Malaysia MDA Issues Guidance on Changing Registration Ownership

January 6, 2017

New guidance from Malaysia’s Medical Device Authority (MDA) describes procedures for changing ownership of a medical device registration.

In Malaysia, a local manufacturer or its local authorized representative is responsible for registering a medical device with the government. The new guidance says that a change of ownership of a medical device registration is required if:

  • A manufacturer outside Malaysia has set up a company in Malaysia and intends to obtain ownership of a medical device registration from an authorized representative;
  • A manufacturer replaces an existing authorized representative with a new authorized representative for purposes of marketing the device;
  • Two medical device companies merge; or
  • An existing authorized representative ceases operation.

An application to change the ownership of a medical device registration can only be made for completed, not pending, registrations. An application must be made by the new owner through an online portal, following steps laid out in the guidance, and the MDA will need about 30 working days to process it. Both the old and new owners will be notified of the outcome, and the effective date of the change is the date the application is approved.

Read the guidance here: www.fdanews.com/12-30-16-registrations.pdf.