Middle East Medical Devices Regulations
Medical devices market in the Middle East region is very distinct and is displaying exceptional growth with substantial progress. Middle East regulations show certain level of homology with GHTF/IMDRF, wherein the grouping of medical devices is the manufacturer’s responsibility. The Regulatory Authorities (RA) stipulate procedures to be followed by manufacturers during the designing, manufacturing and marketing of all devices in the gulf countries.
Regulatory Affairs services
As the region comprises of multiple states, the regulatory controls are different from each other, but the fundamental principles remain the same. The difference lies with the technical document structure with varied regulations based on regional nuances and process differences also must be understood by the overseas manufacturer for the preparation in their own country with the Embassy or Consulates.
Athreva’s regulatory experts can consult manufacturers with the regulatory process for the authentication with the Embassy and Consulates and define product registration strategy. Since there is a mandate for appointing distributors, Athreva can liaise with the distributor and act as their regulatory partner. Our regulatory team can also endorse for import permit/license and coordinate for audits
Developing the right regulatory strategy for a medical device in ME market is a complex process for successful product development, registration and commercialization. It requires a lot of efforts from cross-functional teams to develop the device right from conception to submission along with understanding the QMS needs in order to be audit ready. Athreva has clear regulatory pathway in developing appropriate and effective regulatory strategy
- Strategizing market entry in Middle East markets and identifying the best markets to commence launch
- Reporting need of any clinical data for country specific registration
- Strategizing QMS/ ISO 13485 needs
In order to start any commercialization activity in Middle East, a local representative along with a distributor is mandatory for all HA correspondences and should be appointed. For a company with multiple products, it becomes a tedious task for the distributor to manage both distribution and the regulatory side, effectively. Specially taking the highly regulated products like medical devices into consideration, there is a special attention needed for regulatory correspondence during the entire course of commercialization including reporting of adverse events. So, it becomes essential that a team should be dedicated for managing regulatory aspects for the manufacturer and liaise with the distributor.
Athreva’s local presence in the ME region helps manufacturer solve this complexity.
- Independent legal representation in countries for foreign manufacturers
- Liaising with distributors to become their regulatory arm
- Support for imports/ customs and regulatory clearance
- Incident reporting and liaising with HAs for event reporting and communicatio