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.

Medical Device Regulatory Affairs

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

Product market entry

After diagnosis of manufacturer’s documentation is conducted and its class is determined, the applicant is informed about the device’s compliance and regulatory status, and if it should be registered or listed. Post assessing all the registration requirements, a certificate of registration or listing will be issued by the MoH. Generally, the approved artworks and designs are needed to be attached to the registration certificates.

  • Formal product classification to determine the route of device entry
  • Support with conducting a diagnosis of the technical file and compilation and submission of new technical files to agency
  • Identification of suitable distributors and liaising with them to become their regulatory arm
  • Support with obtaining a Medical Device National Registry number (MDNR) listing per distributor (for Kingdom of Saudi Arabia)
  • Support for obtaining Free Sale Certificate (FSC)

Regulatory strategy

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

Support for Labelling, Promotional material design and technical file scientific translation

It is essential to ensure that the label designs are as per country specific guidelines and adhere to language requirements. Athreva can support you to ensure your labels and technical files are compliant

  • Regulatory support for labelling design
  • Gap analysis of labels
  • Promotional material design
  • Local language translation

Authorized representation

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

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