Medical Device Authority Approved
We support procurement teams with certified medical products, tender- ready documentation, and reliable delivery cycles across Malaysia.
Why Choose Genuine Diamond?
Licensed by Medical Device Authority, Genuine Diamond has over 44 technical codes, specialising in In-Vitro Diagnostic Medical Devices. Click here to see our technical codes.
Requirements under MDA
To register a medical device in Malaysia, a manufacturer or importer must engage with a conformity assessment body (CAB) licensed by Medical Device Authority to certify the application. Certified application by CAB will then be submitted to the Medical Device Authority via online registration system called MEDCAST for approval. Before the registration process begins, a manufacturer or importer shall have an “establishment license” for them to legally sell the medical device as part of requirements by Medical Device Authority. Non-local manufacturer shall appoint an Authorised Representative which will be responsible in managing the registration process.
GDSB Core Business
1. Management system certifications
1.1 Quality Management System for Medical Devices (ISO 13485)
1.2 Good Distribution Practice for Medical Device (GDPMD)
2. Product Registration
2.1 Full Conformity Assessment
2.2 Conformity Assessment by Way of Verification
2.3 Re-registration of Registered Medical Device
Impartiality
GDSB are committed to the avoidance of potentially situations regarding conflict of interest. This effort covers all potential sources of conflict of interests that are identified, whether they arise from within GDSB or from the activities of other persons, bodies or organizations. GDSB does not:
- Provide any consultancy service to client.
- Outsourced audits required by the certification process to any organization.
- Offer its services in such a way that the client has the impression that the would gain advantages if a specified consultancy organization were used.