Malaysia’s Medical Device Authority (MDA) has extended the deadline for expedited medical device registrations by one year to June 30, 2016. As reported in a previous news brief, device registration was originally slated to become mandatory in Malaysia as of July 1, 2015.
Once medical device registration becomes mandatory, foreign medical device companies will have to go through three basic steps to register their product:
- Appoint an Authorized Representative (AR) in Malaysia to register their devices and handle post-market surveillance requirements.
- Have the AR prepare the registration application dossier CSDT and submit it to the MDA through an online system.
- Obtain a Conformity Assessment Body (CAB) certificate issued by an independent CAB after they assess the registration application dossier. This certificate must be submitted to the MDA in order to receive registration approval.
Device manufacturers who submit a registration application to the MDA before the new deadline of June 30, 2016 will be granted an expedited registration and allowed to sell their products without approval from the MDA even after the mandatory registration requirement goes into effect on July 1, 2016. These companies are allowed three years to obtain and submit a CAB certificate.
After June 30, 2016, medical device companies that have not submitted a registration application must undergo the full CAB assessment and registration approval process before they can start selling their device products in Malaysia. There may be long delays in obtaining product approval if device companies submit their registration applications after the deadline passes, as there is a serious backlog of applications pending review by the MDA and CABs.