MDS-REQ-009-V1/220731
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Version Number: 1
Version Date: 2022/07/31
MDS-REQ 9
“Translated Copy”
Requirements for Licensing of Medical Devices Establishments
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Table of Content
Introduction ................................................................................................................................... 3
Purpose ........................................................................................................................................ 3
Scope .......................................................................................................................................... 3
Background ................................................................................................................................. 3
Responsibilities and Authorities of SFDA ................................................................................... 5
Requirements for Licensing of Medical Devices Establishments .............................................. 6
A. General requirements ........................................................................................................ 6
B. Specific Requirements and Obligations .......................................................................... 10
1. Manufacturers ................................................................................................................... 10
2. Authorized Representatives .............................................................................................. 11
3. Importers, Distributors and Optical Establishments ......................................................... 13
4. Warehouses ...................................................................................................................... 15
5. Establishments of Clinical Trials Verification ................................................................. 16
6. Service Providers of Conformity assessment and quality management system ............... 17
7. Service Providers of Testing (Laboratories) ..................................................................... 19
8. Service Providers of Quality Assurance and Radiological Measurements for Health
Establishments .................................................................................................................. 21
9. Service Providers of Medical Maintenance ...................................................................... 23
10. Service Providers of Technical Consultation ................................................................... 25
Final Provisions ........................................................................................................................... 26
Annexes......................................................................................................................................... 27
Annex (1): Definitions & Abbreviations ................................................................................... 28
Annex (2): License extensions and fees .................................................................................... 31
Establishments type ................................................................................................................... 31
Annex (3): List of Changes on the Previous Version ................................................................ 32
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Introduction
Purpose
The purpose of this document is to Specify and Clarify the licensing requirements and
obligations for medical devices establishments which subject to the Medical Devices Law
and its Executive Regulation.
Scope
This Requirement applies to the following medical devices establishments including
electronic activities:
1. Manufacturers
2. Authorized Representatives
3. Importers, Distributors and Optical Establishments
4. Warehouses
5. Establishments of Clinical Trials Verification
6. Service Providers of Conformity assessment and quality management system
7. Service Providers of Testing (Laboratories)
8. Service Providers of Quality Assurance and Radiological Measurements for Health
Establishments
9. Service Providers of Medical Maintenance
10. Service Providers of Technical Consultation
This Requirement does not apply to pharmacies, partial sale establishments, and Labs
which defined in Annex (1), however obligations from the Medical Devices Law and its
Executive Regulation shall be followed, in addition to obtaining the necessary licenses
from the competent agencies/authorities.
Background
SFDA has issued this document in reference to Article six of the “Medical Devices Law”
issued by Royal Decree No. (M/54) dated 06/07/1442 H which stipulates that “an
establishment shall not engage in any of the activities subject to this Law unless
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registered and a license is obtained” and article ten which stipulates that “The
Regulations shall specify the conditions and procedures necessary for registration;
issuance of the marketing authorization; and for license issuance, renewal, amendment,
transfer, and revocation.” and Articles (2/6) of the Medical Devices Executive Regulation
issued by Board Resolution No. (3-29-1443) dated 2/19/1443 H, which state that
“Establishments that practice any aspect of the activities subject to the provision of the
Law and its Regulation shall obtain a license for the establishment itself, its branches and
its warehouses by the SFDA in accordance with the conditions and requirements
mentioned in this regulation".
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Responsibilities and Authorities of SFDA
1. study and verify that the applicant's applications and information are sufficient and
appropriate and meet all the requirements.
2. An establishment inspection to ensure that all requirements have been met.
3. Notifying the establishment of receiving the information required to license and it
has fulfilled the licensing requirements.
4. During the licensing process, confidentiality of information viewed by the
employees or those contracted with shall be maintained.
5. A determining the fees for issuing a license for each establishment of medical
devices in accordance to Annex (2).
6. Issuing the license for the establishment after fulfill all requirements, valid for one
year or similar renewable periods.
7. Reject license request for establishments that does not meet all requirements, and
notify the applicant of rejection reasons.
8. Periodic supervision and inspection shall be applied to ensure establishment’s
compliance with SFDA’s regulations and requirements.
9. Take proper actions in case of negligence, violation or manipulation of the SFDA's
law, regulations or requirements, and the penalties and fees shall be applied
according to Medical Device laws and its executive regulations.
10. Investigate any complaint submitted by establishments or their beneficiaries; and
ensure they are objectively evaluated according to the followed procedures.
11. Commitment to publish a list of all licensed establishments on the SFDA's website,
along with a statement of their activities.
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Requirements for Licensing of Medical Devices Establishments
Establishments that wish to engage in any of the activities subject to the law, including
electronic activities, shall obtain an establishment license from the SFDA, as well as its
branches and warehouses, in accordance with the general and specific requirements
contained in this document.
A. General requirements
1. Obligation to all requirement, conditions, and legal procedures before applying for
license from the SFDA and provide evidence of compliance.
2. Each establishment shall have a legal entity/or be a part of a legal entity in
accordance to the KSA’s regulations, to be considered as a legally responsible for
its activities and decisions.
3. All medical devices manufacturers, importers and distributors of categories (A) and
(B) shall obtain a Quality Management System certificate from a SFDA’s
accredited Conformity Assessment Bodies (CAB) for medical devices and for
quality management system, in accordance to the Saudi Standard (SFDA.MD/GSO
ISO 13485) or its equivalent.
Note: The SFDA’s accredited conformity assessment bodies means that those
whom carry out their activities inside the Kingdom and have a license from the
SFDA, or those located outside the Kingdom and accredited by the International
Accreditation Forum (IAF)
4. Authorized representatives, importers and distributors of categories (C) and (D)
shall submit evidence of the application of the Quality Management System or an
inspection report from the SFDA, that confirms their compliance with the
requirements of the Quality Management System in accordance with the Saudi
Standard (SFDA.MD/GSO ISO 13485) or its equivalent.
5. Following up all SFDA’s issuance related to rules, regulations, conditions,
requirements, circulars, guidance and instructions, and any amendment or update
published on the SFDA’s website and informing beneficiaries and relevant
establishments of that.
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6. Create an account in “GHAD “ system to obtain an establishments number.
7. Submitting application request through SFDA's “GHAD “ system the for the
purpose of obtaining or renewing a license to practice the activity.
8. Submit all required documents through the SFDA's “GHAD “ system .
9. Pay the License’s fee accordance the periods listed in annex (2).
10. The establishment shall Provide a database to archive all relevant data and
documents in order to be easily accessed and retrieved for a period of no less than
(5) years.
11. No medical devices shall be circulated in the KSA unless it gets registered and
obtain a marketing authorization from SFDA.
12. Provide upon request to SFDA any documents and information within (10) days.
13. A sufficient and appropriate human and other necessary resources shall be provided
to do their duties with efficiency, transparency, impartiality, independence and
integrity.
14. Documented and effective procedures for storage and transportation shall be
available and applied according to the requirements for medical device
transportation and storage published on the SFDA’s website.
15. All advertising and promotional materials for medical devices shall not be
promoted unless it gets the SFDA approval in accordance with the requirements for
approval of advertising published on the SFDA’s website.
16. Empowering inspectors to review documents and verify all information during
inspection.
17. Notify SFDA regarding any changes to the information submitted to obtain the
license within (10) days of the occurring change.
18. Adhered to post-marketing surveillance requirements of medical devices, which
include but not limited to:
18.1. Informing/report to the Center about accidents of medical devices, and
provide the center with all the necessary information and documents,
including supply and distribution data.
18.2. Informing/report to the Center about safety alerts that affect the kingdom
according to the time plan approved by the center.
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18.3. Determining risks related to safety alerts that affect the Kingdom, with
providing supply and distribution information.
18.4. Providing a corrective action implementation plan that specifies the
execution end date.
18.5. Providing proof of safety alarm implementation completion in accordance
with the center’s approved plan.
19. Inform the SFDA immediately if the establishment cannot continue to meet the
provisions and license requirements.
20. SFDA should be Informed immediately if the establishment cannot keep fulfilling
the provisions and license requirements.
21. Inform the SFDA about medical devices that violate the provisions and
requirements of the Medical Devices Law and its Executive Regulation including
falsified medical devices without marketing authorization, and report cases of
suspicion.
22. A license renewal application can be submitted before (60 days) from the expiration
date of the valid license.
23. SFDA should be notified in case of requesting license amendment through “GHAD
“ system and submit required documents.
24. If the establishment wishes to cancel its license or upon license expiry date and is
not willing to renew, he shall submit the application through “GHAD “ system of
the SFDA / notify the SFDA and provide proof that there are no obligations on the
establishment.
25. To cancel a license, before license expiry date or not willing to renew a license, an
establishment shall submit the application through “GHAD “ system and notify
SFDA, as well as provide proof that there are no obligations on the establishment.
26. Commitment not to share any documents of the SFDA to any other party, whether
inside or outside the Kingdom, without a prior written consent from SFDA, and
establishment is fully responsible for maintaining the confidentiality of
information.
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27. Commitment to implement SFDA’s recommendations after the inspection visits
and provide a corrective plan to address cases of non-conformity - if any - and
implement the plan after acceptance by the SFDA within a specified period.
28. Provide a corrective plan to address cases of non-conformity - if any -after SFDA’s
inspection visit and implement the plan within a specified period after SFDA’s
approval.
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B. Specific Requirements and Obligations
In addition to what is mentioned in the general requirements, each establishment shall
comply with the specific requirements Listed below according to the type of each
establishment.
1. Manufacturers
Specific Requirements
1. Provide a proof of compliance to what is stated in point (3) of the “General
Requirements” section.
2. Hiring a full-time technical Managers who are biomedical engineers, technicians
or qualified in one of the related fields.
3. Hiring a full-time quality managers who are biomedical engineers, technicians or
qualified in one of the related fields.
4. Specifying the manufacturer’s activity and the level of risk for medical devices that
are going to be manufactured.
Obligations
1. Compliance with the requirements of medical device Unique Device Identification
(UDI) which published on SFDA’s website
2. Commitment to provide after-sales services for their medical devices, including
approved spare parts that meet standards and technical requirements of the device
to ensure continuity of its function according to its intended porous.
3. A pledge to obtain a marketing authorization certificate from the SFDA before
trading any medical device or supplies in the kingdom according to the
requirements for medical devices marketing authorization which published on
SFDA’s website.
4. A pledge of full responsibility from the manufacturer regarding the quality of all
manufactured batches.
5. Conduct all necessary technical tests to prove compliance of their products with
regulatory requirements for safety, performance and quality.
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6. All technical and reference tests shall be conduct according to technical standards
issued by standardization bodies and standards organizations.
7. Commitment to classify medical devices according to the classification system
published on the SFDA's website.
8. Comply with the SFDA’s special requirements for home use or implanted medical
devices.
2. Authorized Representatives
Specific Requirements
1. Provide a proof of compliance to what is stated in point (4) of the “General
Requirements” section.
2. To be present in the Kingdom.
3. Obtain a separate license for each establishment that have been represented within
the Kingdom,
4. Ensure there is no other authorized representative has been appointed for the same
class or general group of medical devices.
5. Documentation of the necessary processes for performing the tasks assigned to him
with attachment of relevant documents.
6. Agreement with the manufacturer shall be documented, approved and subject to the
regulations in the Kingdom.
7. The agreement with the manufacturer shall include the following information -at
least: -
7.1.Specify the activities in which the authorized representative acts on behalf of
the manufacturer in its dealings with the SFDA.
7.2. Type or group of medical devices subject to the Medical Devices Law and
Executive Regulation to be marketed in the Kingdom.
7.3.Authorized Representative shall comply with all requirements for post-
marketing surveillance published on the SFDA's website.
7.4.Determine the duration of agreement between the parties, as one of them may
terminate it in accordance with the following:
7.4.1. In order to terminate the Agreement, the manufacturer shall provide
written notice to the authorized representative.
7.4.2. Manufacturer shall appoint a new Authorized Representative and
transfer all previous obligations to him immediately upon termination
or non-renewal of the previous Authorized Representative Agreement,
and shall notify the SFDA with that.
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7.4.3. In order to terminate the Agreement, the Authorized Representative
shall provide written notice to the manufacturer.
Obligations
1. Confirming the continuance accuracy and validity of information which previous
submitted on an annual basis, as SFDA shall evaluate any changes to the delegation
and take appropriate action if necessary.
2. Notify the manufacturer and confirm that no more than one authorized
representative has been appointed for the same type or general group of medical
devices that he wishes to represent within the KSA.
3. Represent the manufacturer in its interactions with the SFDA, and provide any
information or documents requested by the SFDA.
4. Cooperating with SFDA in studies and procedures taken during post-marketing
surveillance.
5. Inform the SFDA of any incidents occurred outside the Kingdom related to the
medical devices traded in the Kingdom; an explanation of the circumstances shall
be submitted along with the corrective actions taken by the manufacturer or
intended to be taken.
6. Inform the SFDA of all corrective actions results from post-marketing follow-up
investigations conducted by the manufacturer for medical devices that are traded in
the Kingdom, explaining the reasons for the corrective actions and providing
information on the measures taken or intends to be taken.
7. Provide a proof of complete implementation of the corrective action for the safety
alarm in accordance to the plan approved by the center.
8. Identify risks related to safety alarms that affect the Kingdom and provide the
supply and distribution information.
9. Cooperating with persons engaged in activities subject to the provisions of the
Medical Devices Law and its Executive Regulation regarding medical devices
traded in the Kingdom under the agreement concluded between him and the
manufacturer.
10. The responsibility of authorized representative towards medical devices covered in
the agreement shall not elapse upon their request to terminate the agreement, unless
the manufacturer appoints another authorized representative to replacement him, or
if medical devices are not available on the market and among the users.
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3. Importers, Distributors and Optical Establishments
Establishment is classified according to the electronic questionnaire in Ghad system,
which includes type of establishment, activities practiced, number of employees, scope of
coverage and type of medical device / requirement and the general group of the medical
device / requirement that will be traded.
Specific Requirements
1. Appoint an authorized person for the establishment to deal with the SFDA, that
holds an appropriate qualification in one of the relevant specialties.
2. Submit evidence of compliance either with points number (3) or number (4) of the
“General Requirements” section according to the category of distributors and
importers.
3. Provide manufacturer information and data for the medical devices to be
imported, along with the authorized representative information for manufacturer
residing outside the Kingdom.
4. Existence of documented procedure for storing and transporting medical device in
accordance with manufacturers requirements, and submitting a pledge to
implement and comply with the procedure.
5. Existence of warehouse license at the establishment or a storage license with third
parties issued by the SFDA in accordance with “warehouse licensing
requirements”, as for the sales centers, it is possible to suffice with a storage area
within the establishment in accordance with “transportation and storage for
medical devices requirements” published on the SFDA's website.
6. Provide a documented and an effective tracking procedure to document contact
data of the manufacturer, information related to supply, distribution and use of the
medical device, quantities supplied, data of transportation and storage, contact
information with users, and information of the medical device in used. Also,
provide a pledge to implement and comply with the procedure.
7. Declaration of conformity indicating the conformity of medical device with the
requirements of Medical Devices Law and its Executive regulations, signed by the
manufacturer.
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Obligations
1. Importing and/or distributing medical devices that comply with the requirements
of the Medical Devices Law and its executive regulations.
2. Ensure that all necessary documents are present with each medical device:
a. Marketing Authorization Certificate.
b. Declaration of conformity indicating the compatibility of the medical device
with the requirements of the Medical Devices Law and its executive
regulations, signed by the manufacturer.
c. Unique Device Identification (UDI) of the medical device, which includes the
machine-readable code according to the Unique Device Identification for
Medical Devices requirements published on the SFDA's website.
d. Identifying information and other relevant documents.
e. Contact details of the manufacturer, and the authorized representative if the
manufacturer is outside the Kingdom.
3. A pledge is the manufacturer has been informed, through their authorized
representative regarding applicant's intention to import their medical devices to
the Kingdom.
4. Comply with the manufacturer's instructions and the requirements of medical
devices maintenance which stated in the post-marketing control requirements and
published on the SFDA's website in case of providing maintenance services.
5. If the establishment wishes to provide maintenance services for its medical
devices, it shall comply with the manufacturer's instructions and requirements of
medical devices maintenance stated in the post-marketing control requirements
and published on the SFDA's website. And if the Establishment wishes to
provide maintenance services for medical devices that are not affiliated to it, a
medical maintenance service provider license shall be obtained in accordance
with the Medical Maintenance Service Provider Licensing Requirements.
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4. Warehouses
Specific Requirements
1. Appointing a full-time technical Managers who are biomedical engineers,
technicians or qualified in one of the related filed.
2. Apply storage and transportation requirements for medical devices which
published on the SFDA's website.
Obligations
1. Comply with manufacturer’s requirements in addition to compliance with
transportation and storage of medical devices requirements published on the
SFDA's website.
2. In the event that establishment storage with third parties, the following shall be
adhered to:
a. The renter shall have a storage license with others.
b. A contract shall be signed between the main owner and the renter containing
the information and obligations of both parties in accordance with the
requirements of the SFDA, including data on the areas and spaces allocated
for storage.
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5. Establishments of Clinical Trials Verification
Specific Requirements
1. Completed the electronic application on the SFDA's website for license the
verifies clinical studies’ establishment.
2. Clinical Trials Verification Establishments manager shall be a full-time Saudi
national with a bachelor's degree as a minimum in health or science related
majors.
3. Attach CV, certificates and experiences for clinical trials responsible person.
4. Appointing a full-time Saudi responsible for clinical trials holds an appropriate
academic qualification of not less than a bachelor’s degree, and who has
experience in the field of clinical studies for not less than three years.
Obligations
1. No clinical trials without SFDA approval shall be verified.
2. Compliance with the requirements for clinical trials of medical devices published
on SFDA's website.
3. Proof of compliance to standard of Clinical investigation of medical devices
(SFDA.MD/ISO 14155 Clinical investigation of medical devices for human
subjects — Good clinical practice) or a similar version.
4. Proof of compliance to standard of In vitro diagnostic medical devices
(SFDA.MD/ISO 20916 In Vitro Diagnostic Medical Devices - Clinical
Performance Studies Using Specimens from Human Subjects - Good Study
Practice) or a similar version
5. Appointing a trained and qualified employee and organize a continuous training
programs to develop their skills.
6. Implementation of documented work procedures for the establishment.
7. Providing training programs for employees of the agency executing clinical trials
that suitable to the conducted clinical trials.
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6. Service Providers of Conformity assessment and quality management
system
Specific Requirements
1. Obtaining accreditation from the Saudi Accreditation Center, provided that the
Designation scope is included in accreditation activity. Provisions, requirements
and required documents can be found in designation regulation of conformity
assessment bodies (CAB) and private laboratories and guideline requirements of
designation conformity assessment bodies and private laboratories.
2. Providing the SFDA with a conformity assessment program, including specific
requirements and procedures for each field has been applied for.
3. Providing the SFDA with organizational structure, a list of technical and
administrative staff, and a certified copy of their qualifications, training courses,
and job descriptions.
4. Providing an electronic system to document all procedures for granting
conformity certificates, issuance of technical and financial reports, and all related
procedures for issuing the certificate (for fields that are required). Also, the SFDA
shall granted a full authority to access and electronically link the system.
furthermore, the system shall include, as a minimum, the following:
4.1.The number of applications received and must be detailed by country of origin
or source.
4.2.Number of applications for which conformity certificates were granted, and
SFDA may verify the certificates.
4.3.Number of rejected applications.
4.4.Number of applications for which corrective action was requested.
4.5.Corrective actions completed and documented.
4.6.Number of objections submitted by customers on verification results.
4.7.Any special reports or statistics requested by the SFDA.
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Obligations
1. Bearing professional responsibility for any claims or lawsuits arising from its
activities against third parties.
2. Performing services through any of its branches, and in case it delegates a third
party to perform some of its tasks, it shall be subject to all the requirements
stipulated in this document and obtain SFDA’s approval to delegate tasks and
provide it with a copy of the concluded authorization contracts, while bearing full
legal and financial responsibility for those services provided by a third party.
3. Conformity assessment shall be completed according to the following
mechanism:
a. Inform the establishment of any non-conformities and required corrective
actions, if any.
b. Provide the SFDA with a conformity assessment report in accordance the
approved forms by the SFDA, within a maximum period of (15) days from the
completion of the conformity assessment action.
c. Conformity shall be checked periodically according to the risk assessment.
4. Access to the main company resources shall be available for people in KSA.
5. Keeping a record of people participating in each conformity assessment activity,
including those outside the Kingdom, and to submit it to SFDA upon request or
during audit visit.
6. Applying and following the procedures to guarantee impartiality and integrity,
such as:
a. Employees shall not be involved in design, manufacture, marketing,
installation, maintenance or supply of medical device.
b. Employees shall not have any previously participated in providing consulting
services related to medical device.
c. There shall be no financial interest with the manufacturer, importer or
distributor of the medical device.
7. Apply and maintain a documented policy that guarantees safety and
confidentiality of all documents and information obtained during the conformity
assessment in quality management system. Such documents or information shall
not be disclosed to any person or entity other than the SFDA without explicit
approval from relevant external establishment or manufacturer.
8. Conformity assessment bodies are obligated to provide a service level agreement
with customers in appropriate manner to their designated fields.
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7. Service Providers of Testing (Laboratories)
Specific Requirements
1. Establishment’s manager shall be a full-time with a minimum of bachelor's degree
in one of the relevant fields.
2. Providing quality manual to the laboratory.
3. Submitting a detailed statement of approved tests, products covered by tests
scope, and prices, for consideration by the SFDA.
4. Applying an inclusive laboratory electronic system.
Obligations
1. Obligation to obtain an accreditation from the Saudi Center for Accreditation, the
range of tests and products that were licensed shall be included in the
accreditation certificate within one and a half years from the date of obtaining the
license, but not more than that.
2. Providing the SFDA with organizational structure, a list of technical and
administrative staff, a certified copy of their qualifications, training courses, their
job descriptions, and identification of the devices and equipment needed to
operate the laboratory within one and a half years from the date of obtaining the
license, but not more than that.
3. A licensed establishment may increase the number of tests during the validity
period of the license, as long as the SFDA receives a detailed statement of tests to
be added and products covered by the test scope. After obtaining the license from
SFDA, the accreditation certificate shall include the added tests within one and a
half years after obtaining the license, but not more than that from the date of
obtaining the license.
4. Performing services through any of its subsidiaries, and in the case, it is delegated
to a third party to perform some of its tasks, it shall be subject to all requirements
stipulated in this document and obtain the SFDA's approval to delegate tasks and
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provide it with a copy of the concluded authorization contracts, while bearing full
legal and financial responsibility for those services provided by a third party.
5. A licensed establishment may increase the number of tests during the validity
period of the license, as long as it submits a request that includes details of new
Tests and their accreditation certificate issued by the Saudi Accreditation Center
(SAAC).
6. Committing that all tests are conducted according to the SFDA license and by the
approved price.
7. Tests results shall be issued according to laws and technical regulations,
conditions and requirements, and the establishment is legally responsible for any
resulting damage.
8. Presenting the license, accreditation certificate, organizational structure, technical
departments, and test prices in a visible place at the laboratory entrance, and not
making any modification without SFDA approval. In addition to publishing them
on the laboratory's website.
9. Committing to conduct competency tests organized by SFDA.
10. Preserving intellectual ownership of the standard used, maintaining the
confidentiality of information accessed by him or by his employees or those who
have been contracted with throughout the license period, even after the expiration
of the license and not disclosing any information related to the services without a
prior written consent from the SFDA.
11. Renewing license at least (3) months before its expiry date. The affective of the
renewal will start from the expiry date of the license
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8. Service Providers of Quality Assurance and Radiological Measurements for
Health Establishments
Specific Requirements
1. Appointing a Saudi radiation protection officer licensed by the Nuclear and
Radiological Control Commission, and providing the SFDA with a copy of
the radiation protection officer’s practice license.
2. Provide the SFDA with a copy of the license to practice radioactive materials
in the case that the establishment uses radioactive materials.
3. Provide the SFDA with a copy of engineering plan for radioactive sources
storage area in the case that the establishment uses radioactive materials.
4. Saudi specialists / technicians and experts with a minimum of a bachelor's
degree qualification are required in one of the following disciplines
biomedical engineering, medical physics, or any related specialty.
5. Providing measuring devices and simulators compatible with international
standards and recording their data in the licensing form. Provide SFDA with a
list of all assistive devices for measuring and calibration devices.
6. Provide SFDA with organizational structure, a list of technical and
administrative staff, a certified copy of their qualifications, training courses
and job descriptions.
7. Provide SFDA with a copy of procedures and steps followed to implement
each requested service to obtain a license, with an explanation of approved
scientific reference for conducting tests method.
8. Provide a certified copy from radiation protection and safety program at the
establishment in both Arabic and English, which describes the radiation
protection system used and proposed emergency response plan in the case of
an accidental radiation hazard, and radiation technical consultancy service
providers are excluded.
Obligations
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1. In compliance with what is mentioned in protection against ionizing radiation
general instructions in the Kingdom and safe transportation of radioactive
materials instructions in the Kingdom or any other documents issued by
competent authorities.
2. Referring to approved scientific references for all technical reports issued by the
establishments.
3. Adding related activity to quality assurance services and radiological
measurements provision in the commercial registration after obtaining the SFDA's
license.
4. It is not allowed to use unlicensed radioactive sources in terms of number, type
and radioactivity.
5. It is not allowed to sell, rent, lend or donate radioactive sources to another
establishment without obtaining approval from competent authorities.
6. It is not allowed to transfer fixed radioactive sources to any other place within the
establishment without obtaining approval from competent authorities.
7. Disposal of radioactive sources when they are not needed anymore shall be done
in accordance to the general instructions for radioactive waste management and
the general instructions for protection against ionizing radiation in the Kingdom.
8. Inform the SFDA in the case of a failure in one of radiology and medical imaging
devices quality assurance tests, or in the case of a defect in radiology rooms
shielding within (3) days of test results report issuance with attaching a copy of
the report. The report shall include a recommendation whether to continue using
the device or not.
9. Provide personal radiation dose measurement cards for all employees while
keeping records for 5 years.
10. Obtaining valid calibration certificates for all measurement devices from
accredited laboratories.
11. It is not allowed to change work sites or violate the license without obtaining the
prior approval from the SFDA.
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9. Service Providers of Medical Maintenance
Specific Requirements
1. Providing technical staff of engineers and medical maintenance technicians
according to the following conditions:
1.1.With academic or technical qualifications in biomedical
engineering/technology or a related field.
1.2.They shall receive specialized training from the manufacturer or from a
trained person by the manufacturer on their medical devices.
2. Provide appropriate testing equipment to examine medical device function, its
calibration, efficiency of performance and safety, which must comply with the
measurement and calibration system issued by Royal Decree No. (M/51) dated
13/11/1434 AH, and its executive regulations and related instructions.
3. Providing SFDA with organizational structure, a list of technical and
administrative staff, a certified copy of their qualifications, training courses and
their job descriptions.
Obligations
1. Providing a maintenance management system and an inventory management
system for collecting, storing, organizing, analyzing and recording data of the
medical device in addition to the necessary spare parts, and a list of all spare parts
suppliers approved by the manufacturer.
2. Providing original spare parts to the department/person requesting maintenance
service at health care establishment immediately, as delays are not acceptable
except with justification in case of corrective maintenance.
3. Instructions application issued by the manufacturer regarding corrective
maintenance and calibration. In case the instructions are not available, it shall be
referred to the technical specifications approved by the SFDA.
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4. Providing a suitable storage spaces for medical devices, products and spare parts
as recommended by the manufacturer and in accordance with the requirements for
transportation and storage of medical devices.
5. Providing a designated and equipped place for the medical device’s maintenance.
6. Ensure that test equipment has been calibrated by the manufacturer or an
accredited entity, in accordance with the measurement and calibration system
issued by Royal Decree No. (M/51) dated 11/13/1434 AH, its executive
regulations and related instructions, and maintain calibration certificates.
7. compliance with maintenance requirements contained in post-marketing control
requirements for medical devices, which are published on SFDA's website.
8. Implementation of the documented work procedures.
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10. Service Providers of Technical Consultation
Specific Requirements
1. Establishment manager shall be a full-time, with a minimum of bachelor's degree.
2. Providing SFDA with organizational structure, a list of technical and
administrative staff, and a certified copy of their qualifications, training courses,
and job descriptions.
3. A qualified technical officer shall be appointed for each activity, with a bachelor's
degree as a minimum, according to the requirements contained in the Guide for
Licensing Consulting Services Establishment.
4. A copy Saudi Commission for Health Specialties certificates for establishment’s
employees.
5. Providing a quality system within the establishment that clarifies approved work
procedures and methods of keeping customer’s technical reports.
Obligations
1. Maintaining confidentiality of information viewed the establishment, their
employees or those contracted with during the license period and also after the
license expiry and not revealing any information related to provided services.
2. Experience and full knowledge in the SFDA’s field of work and its regulations;
and the principles of independence, impartiality and integrity, with ensuring that
there is no conflict of interest in the provided services in case there is more than
one activity at the establishment, and ensuring the independence of the technical
staff participating in the consultations from any activity of supplying or
distributing products in the same field of consultations.
3. Committing that the provided consulting services is approved by technical staff
and technical officer in the consulting establishment.
4. Providing a training plan to development establishment's employees in the
licensed fields, and committing to provide technical staff with training courses.
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Final Provisions
1- Adhere to Medical Devices Law, its Executive regulations, and requirements
contained in this document, if non-compliance occur, penalties and violations will
be applied to the violating establishments according to the approved schedule of
violations and penalties published on the SFDA’s website.
2- Establishments have the right to object to the SFDAs decision regarding
establishment’s licensing and provide justifications for that. The objection shall
be in accordance with the applicable legal procedures.
3- Establishment wishes to cancel its license or when finish submitting application
request through SFDA electronic system shall notify SFDA as well providing a
proof there are no obligations on the establishment.
4- Obligating not to use the SFDA name or logo for the purposes of advertisement or
place them on any products or on establishments.
5- Establishment shall commit the principle of independence, impartiality, and
integrity, and ensure that there is no conflict of interests in the services provided
in the case that there is more than one activity at the establishment. and guarantee
independency.
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Annexes
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Annex (1): Definitions & Abbreviations
KSA
Kingdom of Saudi Arabia
SFDA
Saudi Food and Drug Authority
Law
Medical Devices Law
Regulation
Executive Regulations of the Law
NCMDR
The National Center for Medical Devices Reporting
Medical Devices
Any instrument, apparatus or implement or implant or in vitro reagent or calibrator
or software, or material used for operating medical devices, or any other similar
or related article, intended to be used alone or in combination with other devices
for diagnosis or prevention or monitoring or controlling or treatment, or alleviation
of disease or injury, or for compensation for an injury; investigation, replacement,
modification, or support of the anatomy or of a physiological process; supporting
or sustaining life; controlling or assisting conception; sterilization of medical
devices; providing information for medical or diagnostic purposes by means of in
vitro examination of specimens derived from the human body; and does not
achieve its primary intended action by pharmacological, immunological or
metabolic means, but which may be assisted in its intended function by such
means.
Medical Supply
A medical material or product used in diagnosis, treatment, replacement, or
correction/ straightening; or in disability cases or other medical uses for humans,
including medical gases.
Medical Radioactive
Material
A material that emits ionizing radiation either by itself or when used with other
medical devices or supplies for the purpose of diagnosis and treatment.
Establishment
A legal entity engaged in an activity related to medical devices and supplies.
Manufacturer
Any national or foreign establishment the purposes of which include designing or
manufacturing medical devices or supplies for use under its name within the
Kingdom or abroad. Manufacturing shall include refurbishing, assembling,
packaging, and labelling.
Health Care Provider
Any government or private establishment that provides health care services.
Authorized
Representative
A legal person based in the Kingdom who has written authorization from a
manufacturer located outside the Kingdom to represent it in the Kingdom with
regard to the implementation of this Law and its Regulations.
Consultation Services
Establishments
Establishments that provide technical consultation services related to regulatory
affairs to the establishments engaged in the field of medical devices in the
Kingdom market.
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Clinical Trials
Verification
Establishments
Establishments that take charge of follow up clinical trials and conduct all
activities related to clinical trials verification.
Circulation of Medical
Devices and Supplies
The provision of medical devices and supplies at no cost or for a fee, whether for
distribution or use.
Registration
A procedure for listing in the MDNR any medical device or supply and any
establishment that engages in any activity governed by this Law.
Marketing Authorization
A document issued by the SFDA permitting the circulation of a medical device or
supply in the market.
Classification System
A system approved by the SFDA to assess the safety and the level of risk of a
medical device or supply.
Quality Management
System
A system approved by the SFDA to verify the quality, effectiveness, and safety of
a medical device or supply in accordance with the latest edition of the Technical
Standard (ISO 13485) or its equivalent, as provided in the Regulations.
Quality Assurance
A set of technical tests, measurements, and calibrations approved by the SFDA to
verify the safety, accuracy, and quality of medical radiological devices, in order
to ensure the efficacy of diagnosis and treatment.
Technical Regulations
Mandatory documents issued by the SFDA for medical devices and supplies which
specify the basic standards of safety, performance, and manufacturing and provide
relevant instructions, including terms and symbols as well as packaging and
labelling requirements.
Standards
Non-mandatory documents approved by the SFDA, including rules, guidelines,
specifications of medical devices and supplies, or production processes and
methods related thereto as well as terms and symbols, and packaging and labelling
requirements.
Label
Any statement, information, or illustration printed on a medical device or supply,
including identifying information, technical description, method of use, and
manner of storage and transportation.
Safety Alert
A notice issued by the National Center for Medical Devices Reporting indicating
the risk associated with a medical device or supply and the corrective action
required to avoid such risk.
Field Safety Corrective
Action
An action taken by the manufacturer to limit or reduce the risks compromising the
safety of a medical device or supply.
Medical Imaging
Materials
Any material used to improve contrast that can be obtained by using medical
imaging techniques.
Importer
An establishment in the supply chain that supplies a medical device to the
Kingdom.
Distributor
An establishment in the supply chain that supplies a medical device to another
distributor or its end user.
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Traceability
Procedures and measures that enable the tracing of medical devices, at any stage
of the supply chain.
Advertising
Any statement, whether written, audible, visual, or otherwise matters intended to
promote a medical device or its technology, or direct or indirect sale.
Inspection
A systematic and documented procedure carried out by the SFDA to verify
establishment or manufacturer’s obligation with the particular conditions and
requirements for establishments and medical devices determined by the Law and
its Regulation.
Applicant
A natural or legal person who meets the necessary conditions and has an
authorization from the establishment.
Warehouse
A building or part of it licensed by the SFDA and designated for medical device
storage.
Unique Device
Identification (UDI)
A series of numbers and letters created through approved specifications in order
to identify a medical device specifically and clearly throughout all stages of its
circulation.
Calibration
The required correction adjustments to medical devices to maintain its
performance accuracy according to standard.
Suitable test equipment
Devices or instruments used to perform functional or calibration tests of medical
devices.
Maintenance
management system
It is used to automate processes related to technical support for medical devices,
provide support for the inventory management system for the medical device,
corrective maintenance, periodic preventive maintenance (PPM) and contract
management, and provide a wide range of different data reports related to the life
cycle of the device or medical device.
Corrective maintenance
(CM)
Unscheduled process used to restore the physical integrity, safety and/or
performance of a device after a failure. it includes the repair, restoration, or
replacement of used components or systems with the intent of restoring the safety
and performance of the medical device or supply.
Partial sale
establishments
Establishments that carry out the process of selling medical devices for home use
to the end user through retail markets such as canters, exhibitions, points of sale
and electronic stores, but are not primarily involved in importing and distributing
medical devices.
Laboratories
Prosthetics, audio-visual, dental and similar services laboratories.
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Annex (2): License extensions and fees
Note
Financial
compensation
License
period
Establishments type
5000 SAR
5 Years
Medical devices
manufacturers
According to customer's
choice and period of the
contract
2600 SAR Per year
From one to 10
years
Authorized Representative
*Establishment is classified according to the electronic
questionnaire in the Ghad system, which includes type of
establishment, activities that are practiced, number of
employees, scope of coverage, and categories of devices.
Distributors and importers of medical devices *
25000 SAR
Yearly
Class A
15000 SAR
Yearly
Class B
8000 SAR
Yearly
Class C
5000 SAR
Yearly
Class D
**Establishment is classified according to the electronic
questionnaire in the Ghad system, which includes type of
establishment, activities that are practiced, number of
employees, scope of coverage, and categories of devices.
Optics Establishments**
7500 SAR
Yearly
Class A
5000 SAR
Yearly
Class B
2500 SAR
Yearly
Class c
Storage license with
third parties (800 SAR)
each year
4000 SAR
5 Years
Medical devices
warehouses
Domain is from (20,000
/ or 40,000) SAR, in
addition to each country
/ 1000 SAR
Depends on the domain and
adding countries
3 Years
Conformity assessment
establishments and quality
management system
5000 SAR
5 Years
Clinical Trials Verification
Establishments
1000/ Scope
5 Years
Service providers of
Technical advisory
services for medical
devices
License is valid for five
years. License fee is
5,000 riyals for the main
laboratory and 2,500
SAR for each branch
1000/ Designation
3 Years
Medical device testing
services providers
According to the
customer's choice
1000 SAR For each year
From one to 5
years
Maintenance services for
medical devices providers
Activity:
Ensuring quality of
medical x-ray
equipment.
5000 SAR
3 Years
Quality assurance and
radiological measurements
services providers for
health establishments
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Annex (3): List of Changes on the Previous Version
Changes Description
• The following documents have been replaced and the requirements
contained in the old document has been included in this document:
- Rule of Procedure for Establishment Registration (IR2)
- Rule of Procedure for Establishment Licensing (IR4)
- Procedural Rule for Licensing Legal Representatives (IR5)
- Guidelines for distributors and importers of medical devices (G1)
- Domestic Manufacturers' Guide (G2)
- Guidelines for legal representatives of medical devices (G3)
- Guidelines for Overseas Manufacturers (G4)
- Guidelines for licensing requirements for providers of quality assurance and
ionizing radiological measurements services for health establishments (G51)
- Guide to the Saudi Food and Drug Authority requirements for licensing providers
of quality assurance and radiological measurements services
