Overview and History
Malaysia presents a robust and influential market for foreign medical device and drug companies looking to expand their presence to Southeast Asia. The oversight of medical devices in Malaysia falls under the Medical Device Authority (MDA), which operates as part of the Ministry of Health (MoH) in Malaysia. To introduce a device to the Malaysian market, it must undergo registration with the Malaysian Medical Device Authority (MDA), and foreign medical device manufacturers are required to designate a Malaysia Authorized Representative to facilitate the Medical Device Registration process.
With regards to drug products, the National Pharmaceutical Regulatory Agency (NPRA) is responsible for enforcing the drug registration process. Established in October 1978, the National Pharmaceutical Regulatory Agency (NPRA), formerly named the National Pharmaceutical Control Bureau (NPCB), was instituted as part of the Pharmacy and Supply Program. Notably, in 1996, the NPRA gained global recognition from the World Health Organization (WHO) as a designated “WHO Collaborating Centre for Regulatory Regulation of Pharmaceuticals.” This recognition was conferred due to the NPRA’s commitment to adhering to drug research and quality control standards through the establishment of appropriate equipment and facilities.
MDA Medical Device Registration
In Malaysia, medical devices are categorized into four levels of risk:
Class A: Minimal risk (examples include blood pressure cuffs, scissors, etc.)
Class B: Low to moderate risk
Class C: Moderate to high risk
Class D: Highest risk (includes implantable devices and those with significant impact on human body physiology)
Medical Device manufacturers lacking a local presence in Malaysia are required to engage a Medical Device Authorized Representative within the country. This representative acts as an intermediary between the manufacturer and the Medical Device Authority (MDA), facilitating the registration process and application submission.
To navigate this process, MedCast serves as a web-based Medical Device Centralized Online Application System for MDA registration. However, utilization of MedCast is restricted to local Authorized Representatives. These Malay representatives need to possess an establishment license along with a certificate demonstrating compliance with Good Distribution Practices for Medical Devices (GDPMD).
For Class B, C, and D devices, manufacturers must engage a Conformity Assessment Body (CAB) for an abridged technical review of their documentation. Essential documents like ISO certificates and CE Certificates must be provided to the CAB. Upon successful review, the CAB will issue the necessary certificate.
To finalize the device registration, a comprehensive package encompassing the Common Submission Dossier Template (CSDT), the CAB certificate, and the application must be submitted electronically to the MDA for evaluation and approval.
It’s important to note that both the CAB and Device registration certificates must be renewed every five years.
NPRA Drug Registration
In Malaysia, drugs are divided into four distinct groups, specifically new pharmaceutical products, biologics, over-the-counter (OTC) generics, and generics.
The National Pharmaceutical Regulatory Agency provides the option of online registration through the Quest 3 system available on its website. However, prior to commencing the registration process, applicants are required to go through certain steps. This involves applying for a Quest 3 membership and obtaining a USB token. Upon receiving the USB token, applicants can access the registration portal and proceed with the online application.
Outlined below is a summarized overview of the online product registration process by the National Pharmaceutical Regulatory Agency:
- Visit the NPRA website (www.npra.gov.my) and navigate to the Industry section, followed by First Time User and USB Token Registry.
- Apply for Membership in NPRA QUEST 3.
What are the requirements?
– Complete the Company Registration Form.
– Submit a Letter of Company Authorization.
– Provide a photocopy of the applicant’s identification (I/C photocopy).
- Purchase the USB Token Quest 3 from MSC Trustgate after receiving Quest membership approval.
- Log in to Quest 3 to upload applications for product registration.
- Furnish the requested details to the National Pharmaceutical Regulatory Agency.
- Collaborate with the NPRA officer in case supplementary information is necessary.
- Present proposed items during the Drug Control Authority (DCA) meeting.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.