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Malaysia: Guideline for Re-Registration of Registered Medical Device by MDA

On September 15 2022, the MDA has issued second edition of guideline document entitled “Re-Registration of Registered Medical Device” (MDA/GL/08).

The following information are added on the guideline:

  1. Applicant is not allowed to submit re-registration application concurrently with change notification application; and
  2. Requirements on Pre-Market Clearance / Approval

All application shall undergo conformity assessment via verification route for registered medical devices:

a) Valid CE marking or pre-market approval as per circular 2/2014 conformity assessment procedures for medical device approved by recognized countries shall be submitted.

b) Removal of CE marking shall be notified to MDA via change notification. This letter shall be submitted to CAB, in order to do conformity assessment via verification route.

c) All the registered application that was approved under full conformity assessment also will undergo verification route with CAB for re-registration.

You can read about the amended guidelines in full on the MDA website here.

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