All medical devices that are imported, exported, or placed on the market in Malaysia whether manufactured domestically or not, must be registered with the Medical Device Authority (MDA) before they can be supplied in Malaysia.
The term ‘medical device’ covers any product used in healthcare for the diagnosis, prevention, monitoring, or treatment of illness or handicap but excludes drugs.
The application for medical device registration shall be made to the Authority through an online, web-based system called “Medical Device Centralized Online Application System (MeDC@St).
The medical device will be registered for 5 years with the Authority. Upon expiry of the medical device registration certificate, the registration holder shall apply for re-registration of the medical device before it can be imported, exported, or placed in the market.
The re-registration process for medical devices shall undergo the following two stages as below:
- Stage 1: Application for conformity assessment conducted by Conformity Assessment Body (CAB)
- Stage 2: Application for re-registration of medical device via MeDC@St.
For a detailed application process, please refer to the link below
https://www.mda.gov.my/documents/guideline-documents/2002-re-registration-guideline/file.html
BUT… if you want to experience a hassle-free application, please let us assist you with properly submitting your registration renewal! Get assistance now!
Call us at +6011 3120 2252 or knock our email at consultant@ansarcomp.com.my
Feel free to visit our website at https://ansarcomp.com.my/
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