Medical Devices & Supplies
Registration of Medical Devices & Supplies and Issuance of Marketing Authorization (MDMA)
We provide comprehensive services for registering medical devices and supplies and preparing product files in accordance with regulatory requirements, starting with product review and classification before registration and importation, and through to completing registration, marketing authorization, and clearance procedures.
Our Services Include
- Reviewing medical device and supply files before registration and importation.
- Determining product classification and regulatory requirements.
- Registering medical devices and supplies and issuing Marketing Authorization (MDMA).
- Registering In Vitro Diagnostic Devices (IVDs).
- Transferring medical device and supply marketing authorization from one company to another in accordance with requirements.
- Issuing import permits for medical devices and supplies for display and training purposes.
- Issuing import permits for biomedical devices according to requirements.
- Reviewing shipment documents and ensuring import and clearance requirements are met before shipment arrival.
- Clearing medical devices and supplies and following up on clearance procedures.
- Clearing products that do not require registration, such as toothbrushes and certain laboratory tools and supplies.
- Addressing comments and obstacles that may affect registration, importation, or clearance.
- Following up on applications with the relevant authorities until procedures are completed.
Related services
Explore other services in Medical Devices & Supplies.