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STEP 1 Appointment of UAE Authorised Representative (Agent)

According to the UAE medical device regulations, non-local legal manufacturers/applicants are required to appoint an Authorised Representative (Agent) company to act as the contact person for the relevant device in the UAE. The Authorised Representative will be responsible for product compliance and post-market surveillance.

STEP 2 Determine the classification of the product

Determine the classification of your device according to the MOHAP classification rules (application submitted by the UAE Authorised Representative and classification approval obtained).

STEP 3 Prepare technical documentation and systems

The company needs to prepare the documents to be submitted according to the requirements of MOHAP and prepare the system certificate (recognised as ISO13485).

STEP 4 Submission of Technical Documents to MOHAP

The manufacturer transfers the completed technical documentation to an authorised representative in the UAE, who then submits it, accepts the questions, and responds to corrections.

STEP 5 MOHAP Approval

Once MOHAP is granted, the licence holder (always the legal manufacturer) can ship the goods to the UAE for sale.