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Frequently Asked Questions

GDPMD FAQs

  • Helps ensure medical device retains its safety and efficacy during transit in the supply chain.
  • Enable swift recalls if and when necessary.
  • Importers, distributors, authorised representatives
  • Understand the GDPMD regulatory requirements
  • Develop and implement standard operating procedures and forms which are compliant with GDPMD
  • Conduct an internal audit to ensure the GDPMD QMS is being followed
  • Have your GDPMD QMS audited by a Conformity Assessment Body (CAB)
  • Apply for the MDA Establishment Licence for Importer/Distributor
  • Allow 2-3 months for the GDPMD training, documentation, implementation and audits.
  • Medical Device Authority (MDA)
  • Usually about 1 month after submission.
  • The GDPMD certificate is valid for 3 years.

Medical Device Registration FAQs

  • The manufacturer if it is a locally manufactured medical device; the LAR if it is an imported medical device.
  • By submitting all the necessary regulatory information and documentation to MDA for evaluation and approval. This has to be done via Medc@st, MDA’s on-line portal.
  • Information about the medical device, the device classification, manufacturer’s information, a Common Submission Dossier Template (CSDT) which includes clinical evaluation, labelling, risk analysis, and an essential principle checklist amongst others.
  • This depends on the medical device’s risk classification. Devices with higher the risk classifications usually need more time than devices with lower risk classifications. Allow 2-6 months.
  • Consultancy fee, CAB product verification fee, MDA fees.
  • MDA fee schedule
Class A Application fee (MYR) = 100 , Registration fee (MYR) = n.a.
Class B Application fee (MYR) = 250 , Registration fee (MYR) = 1000.
Class C Application fee (MYR) = 500 , Registration fee (MYR) = 2000.
Class D Application fee (MYR) = 750 , Registration fee (MYR) = 3000.

ISO 13485 FAQs

  • An international standard that specifies the requirements for a quality management system where an organization needs to demonstrate its ability to consistently meet customer and applicable regulatory requirements for medical devices.
  • In Malaysia, all manufacturers of medical devices need to have ISO 13485 certification before they can apply for a manufacturer’s licence.
  • This depends on the scope of your activities, the size of your operations and availability of your resources to participate in the project.
  • The ISO 13485 certificate is valid for 3 years.

For More Information

NPRA Licensing

Cosmetics

Health Supplements

Traditional Medicine

Generic Medicine

Contact Us

Sentral Business Suites @ Komplek Sentral Point, Taman Kajang Sentral, Kajang 43000, Selangor, Malaysia.

+60 3-8740 8318 , +60 3-8741 7681

Our Services

  • Quality Management System Services
  • Product Registration
  • In Country Representation

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