May 9, 2018

Medical Device Authority (MDA), Malaysia has recently introduced a new initiative calling for e-mail notification subscription by all interested stakeholders. This new initiative by MDA aims to provide the latest information to stakeholders and general public who wish to subscribe to this service, by offering to promote effective dissemination of information to individuals and companies that values on time and direct access to pertinent regulatory information and activities related to medical devices.

As widely known, MDA regularly publishes or issues new regulatory information on medical device on its official webpage, which have to be constantly tracked to get updated on. With this program, updated pertinent information from MDA is directly accessible to the stakeholders such information are including but not limited to the following: Gazettement orders, Regulations, Policies, Guidance documents, Guidelines, Programs, Trainings and other related regulatory information.

MDA targets all interested individuals to promote this service, including manufacturers, authorized representatives, importers, and distributors, conformity assessment bodies (CABs), medical device associations, healthcare institutions or universities, healthcare professionals (HCPs), testing labs, students; and all others in between. Subscribing for this email notification service is relatively easy, as one only needs to provide some pertinent information and pay the required fees. The application form, found on this link, to subscribe to this service needs to be filled in and a tax invoice will be issued by MDA to the applicant via email provided in the application form. All applications will be charged RM 106 per application including 6% GST. The validity of e-mail notification subscription is valid for one (1) year. The subscriber will receive an e-mail reminder 30 days before the expiration date for renewal.