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Medical Devices Regulatory Support in Malaysia

Overview

Malaysian Medical Device Authority (MDA) controls and regulates medical device registration in Malaysia. The MDA was established under the Medical Authority Act 737, 2012. The MDA uses a centralized online application system called the MedCast for submissions related to the Malaysia medical devices registration. The Conformity Assessment Body (CAB), Malaysia, carries out the technical data evaluation under the authorization of the MDA.

Malaysia Medical Device Classification

The devices are classified into four (04) classes based on the extent of risk associated with them.

Device Class

Risk

A

Low Risk

B

Low Moderate Risk

C

Moderate – High Risk

D

High Risk


Medical Device Registration

It is important to carry out Medical device classification in Malaysia because different Regulatory requirements may apply to separate categories. Applicants may submit a classification form which can be downloaded from the NPRA website (www.npra.gov.my) if unsure of the product category.

For any foreign medical device manufacturer, it is mandatory to have a local entity or local presence in the name of an Authorized Representative (AR) in Malaysia to carry out medical device registration with the MDA. The AR is a license holder during the pre-and post-registration process. He/she also performs post-market surveillance activities. The AR must have an establishment license and Good Distribution Practices Medical Devices (GDPMD) certification in Malaysia.

The registration application and the Common Submission Dossier Template (CSDT) should be prepared based on the technical information from foreign manufacturers and submitted to an independent Conformity Assessment Body (CAB), Malaysia, for the technical review. The verification certificate from the CAB is mandatory for a device’s approval with the MDA. Once the CAB certificate is submitted to the MDA, reviews can be conducted. Upon the result of the review, the device will be approved/rejected.

The CSDT must contain the following documents:

  1. General information
  2. Information on the manufacturer
  3. Grouping of medical devices
  4. Common Submission Dossier Template (CSDT)
  5. Supporting documents for the CSDT
  6. Post-market vigilance history
  7. Declaration of Conformity
  8. Attestation for medical device registration application

An independent CAB, which needs to be different from the one engaged by the foreign manufacturer in other countries, reviews the same registration application dossier and then issues a CAB certificate that is submitted to the MDA.

If the device is approved in one (01) of the recognized GHTF member countries (US, European Union, Australia, Japan, or Canada), the review process becomes simplified.

  • Validity of Registration Certificate: Five (05) years
  • Renewal: The renewal application should be submitted six (06) months before the expiration of the existing registration certificate along with documents as required in the online MedCast System.
  • Post-approval Changes (Variations): Any change in the registered medicine should be sent to the NPRA with relevant documents, on a case-by-case basis.

Product Maintenance & Compliance

Sr. No

Application

Validity

01

Validity for Registration Certificate

Five (05) years from the date of registration

02

Renewal

The renewal application should be submitted six (06) months before the expiration of the existing registration certificate, along with the documents, as required in the online MedCast System

03

Post-approval Changes (Variations)

Any change of registered medicine should be sent to the NPRA with relevant documents on a case-by-case basis


Freyr Expertise

  • Authorized Local Representation
  • End-to-end Medical Device Registration with the MDA
  • Regulatory Intelligence & Solutions
  • Preclinical Services - Generation of Scientific Report for Regulatory Submissions
  • MDA Establishment License Application for Authorized Representative, Distributors, and Importers
  • Training and Support in the Development of Medical Devices that Meet the International Standards of the EU MDR, FDA, and CE Marking Requirements
  • Business Development Services - Manufacturer’s Audit and Distributor Search
  • Post-registration Activities & Post Marketing Surveillance

Location

Suite 163E, Level 16,
Gurney Paragon Office Tower,
Jalan Kelawei, 10250 George Town,
Pulau Pinang, Malaysia

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