Malaysia's Leading GDPMD Consultant & ISO 13485 Expert for Medical Device Registration

GDPMD (Good Distribution Practice for Medical Devices) is a mandatory quality management certification in Malaysia. All companies importing, distributing, or representing medical devices must obtain GDPMD certification before applying for an MDA establishment license to ensure proper handling and distribution throughout the supply chain.

The complete process typically takes 3-6 months depending on device classification. Class A devices are fastest (2-3 months), while Class C and D devices may take 4-6 months. Our 98% success rate with 1000+ devices ensures minimal delays.

An MDA establishment license authorizes your company to operate as an importer, distributor, or authorized representative. Product registration (device listing) is required for each specific medical device you want to market. You must obtain the establishment license before registering products.

Medical devices are classified into Class A, B, C, and D based on risk level per the Medical Device Act 2012. Class A has lowest risk (surgical instruments), Class D has highest (implantable devices). Classification determines registration requirements and costs.

While ISO 13485 isn't always mandatory, GDPMD certification is essential for establishment licensing. ISO 13485 is the international quality management standard for medical device manufacturers and is highly recommended as it demonstrates compliance and expedites registration.

Yes, we assist with US FDA establishment registration and device listing for companies exporting to the United States, as well as HSA (Health Sciences Authority) medical device registration in Singapore for regional market access.

Required documents include manufacturer's ISO 13485 certificate, CE mark certificate (if applicable), product technical documentation, labeling and IFU, clinical evaluation reports, risk analysis, and CSDT. Our team guides you through complete documentation requirements.

GDPMD: our fee is RM 5,500 in year 1, plus the certification body (CAB) audit of RM 4,785 per warehouse, paid direct to the CAB. Surveillance years 2-3: our fee RM 2,500 a year, plus RM 2,585 a year paid direct to the CAB; year 4 re-certification repeats year 1. Establishment licence: the MDA licence fee is paid direct to MDA — distributor RM 2,250 (RM 250 application + RM 2,000 licence); importer and authorised representative licences carry their own MDA fees, also paid direct. Product registration, per product with CAB and MDA fees included: Class A RM 3,800, Class B RM 6,800, Class C RM 9,800, Class D RM 12,000. Our fee is payable 50% to kick off and 50% upon approval / completion; monthly payment plans from RM 1,500/month are also available.

With our 98% success rate and 1000+ devices registered, rejections are rare. If MDA requests additional information, we handle all communications and ensure compliance. We conduct thorough pre-submission reviews to identify potential issues before submission.

Yes, you can search the medical device register through the MDA portal or HSA registered medical device database. Our consultants can assist with verification and provide guidance on registration or competitive analysis.