With over 1000+ medical devices registered successfully, we are your trusted GDPMD consultant and ISO 13485 consultant helping manufacturers and distributors navigate the complex landscape of medical device registration in Malaysia with a 98% success rate.
Our extensive experience as a GDPMD consultant in Malaysia spans over a decade, with successful medical device registration across all classifications. We've navigated complex MDA establishment license applications, product registrations, and renewal services for manufacturers worldwide.
As your dedicated ISO 13485 consultant, we provide comprehensive quality management system implementation tailored to medical device manufacturers. Our services ensure seamless integration of regulatory requirements with your operational processes.
Time is critical in the medical device industry. Our GDPMD consultant services expedite your market entry by strategically planning the optimal regulatory pathway, reducing time-to-market by up to 40% compared to industry standards.
We believe quality regulatory services should be accessible to all medical device companies. Our transparent pricing structure comes with flexible monthly payment plans starting from RM 1,500. No hidden fees, no surprises.
Complete support for MDA establishment license application including GDPMD certification, site visits, and compliance guidance (Class A, B, C, D).
ISO 13485 quality management system implementation and ongoing compliance support for medical device manufacturers.
Expert guidance on medical device classification, FDA establishment registration, and HSA registration strategies.
Ongoing regulatory intelligence, compliance training, and medical device register verification assistance.
Medical devices successfully registered with MDA Malaysia
Success rate in medical device registration approvals
Average time to complete registration process
Companies served across Malaysia and Southeast Asia
Our streamlined process ensures your medical devices are compliant and registered efficiently
Site visits, compliance assessment, GDPMD certification, and MDA establishment license application support.
Medical device product registration for Class A-D devices with complete documentation and CSDT preparation.
Annual GDPMD renewal, 3-year establishment license renewal, and 5-year product registration renewal.
Choose the right package for your business needs
One-time fee
One-time fee
One-time fee
Medical device registration by class
Per device
Per device
Per device
For Class D devices and device classification assistance, contact us for a custom quote.
Maintain compliance with our renewal packages
Annually
Every 3 years
Every 5 years
Common questions about GDPMD certification and medical device registration in Malaysia
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.
Establishment license packages: RM 10,000 to RM 25,000. Product registration: Class A (RM 2,500), Class B (RM 6,000), Class C (RM 9,800). Fees include consultation, document preparation, CAB fees, and MDA fees. Monthly payment plans from RM 1,500/month 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.