Table of Contents
Medical Device Registration in Saudi Arabia
Click here to visit SFDA (Authority) website to learn more on medical device registration in Saudi Arabia.
Labels to show the following:
1. The manufacturer name and address
2. The EU representative details (name and address), for non-European manufacturer
3. The product brand name
4. The product model number/ REF number
5. CE marking
6. Date of manufacturing/ expiry date
7. Traceable code (serial/ lot number)
8. Storage conditions as per instruction for use.
9. Power ratings showing 230V 60Hz, if applicable
10. Any special handling or sterilizing method, any special indicators (single use, sterile, IVD, keep away from sunlight, dust rain…etc.)
Instruction for use (IFU):
1. The manufacturer name and address
2. CE marking
3. Date of issuance/ revision…etc.
4. Must show the product name and the models if any
Brochure:
1. The manufacturer name and address
2. Date of issuance/ revision
Declaration of conformity:
1. The product risk class
2. The route to the compliance annex
3. To be printed on your official papers signed and stamped and dated.
For the establishment:
1. EC-certificate for class II or higher,
2. Design examination certificate for class III
3. ISO 13485 certificate
4. The most recent audit report on the EC-certificate 93/42/EC, which needs to be:
a. Complete and in English
b. Signed by the notified body
c. Dated less than a year
d. Contains a recommendation of continuity
Additional documents:
1. The Technical File document in which the intended use and clinical benefits are stated for each device.
2. Analytical performance document in which performance assessment study is conducted for each device.
3. Post-Market Surveillance (PMS) Plan and Report for each device.
Updated additional requirements as of Oct 2020 for medical device registration in Saudi Arabia
Technical File Table of Contents
Detailed Product Description
Essential Requirements Checklist.
All relevant evidence of compliance to Essential Requirements including but not limited to Tests Reports, and Verification & Validation Reports.
Clinical Evaluation Report (CER), and copies of referenced articles.
Complete Biological Evaluation Reports including all biocompatibility testing data.
Post-Market Surveillance (PMS) Plan and Report.
Post-Market Clinical Follow-up (PMCF) Plan and Report.
Risk Management File (RMF).
Risk classification criteria/rule and rationale
Contact
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