Malaysia Medical Device Registration Coming Very Soon!

In the past medical device registration was not required in Malaysia.   This will all change very soon.

Beginning July 1, 2015, device registration will become mandatory in Malaysia.  There are three basic steps in the registration process.  First, a foreign manufacturer needs to appoint an Authorized Representative (AR) in Malaysia who will register their devices.  This is done by creating an ‘Authorisation Letter’ which also includes a list of medical devices to be registered.  Throughout the registration process and after registration approval, the AR will act as the foreign manufacturer’s local agent (license holder).

There are two main advantages of using an independent AR as your local agent in Malaysia. First, by appointing an AR, sensitive technical information will be kept confidential and will not be shared with distributors.  Second, if the foreign manufacturer utilizes an independent third party instead of letting the distributor do the registrations, it is easy to change distributors in the future if the foreign manufacturer wishes to do so. The AR will also be responsible for handling mandatory post-market surveillance activities.  The AR could be (1) your own subsidiary office in Malaysia, (2) a Malaysian distributor, or (3) an independent third party such as Pacific Bridge Medical.

The second part of the process entails the AR preparing the registration application dossier CSDT based on the technical information from the foreign manufacturer.   He/she will then submit the documents to the Malaysian Medical Device Authority (MDA) through an online system.

Third, an independent Conformity Assessment Body (CAB) reviews the same registration application dossier and then issues a CAB certificate that is submitted to the MDA.  The independent CAB must be different from the one engaged by the foreign manufacturer overseas.  The MDA will not approve the product until a CAB certificate is obtained.

A major problem with the new registration system is that the MDA has still not yet specified which documents the CAB will require for review.   As a result, no devices are currently being approved and it could be several months or even years before the MDA develops an efficient registration approval process.  To help remedy this problem, the MDA created a “transition list.”  If a manufacturer (through their AR) submits a registration application dossier for their device to the MDA by June 30, 2015, then their device automatically goes on the “transition list” and can be imported and sold in Malaysia after July 1st, even without registration approval.

However, if a manufacturer (through their AR) submits a registration application dossier AFTER June 30, they will NOT be able to sell their device in Malaysia until after registration approval.  This could take a few years due to the major backlog of applications the MDA and the CABS have to review.  Generally speaking, the products on the transition list will be approved first before products NOT on the transition list.