Medical Device Registration in
Ministry of Health
Medical Device Regulation
Class I, IIa, IIb and III
- Register in the e-services, create a username and password (if not already registered) and access the electronic system.
- Submit the request through the electronic service and complete the payment to meet all conditions and required fees.
- The competent technical committees will deliberate the registration of products and then recommendations are to be submitted to the competent ministerial committee.
- Letters are to be addressed to the concerned companies stating the committee’s decisions.
- The company should complete the requirements and submit them via electronic service.
- The relevant technical and ministerial committees will re-deliberate the registration of products that have been deferred in advance as soon as companies complete the requirements.
- Issuing certificates of registration of products that have been approved.
- Application Form
- CE Mark certificate
- QMS certificate
- Technical documents
- Manufacturing site registration
- Letter of Authorization
45 working days