Medical Device Regulatory Updates in Malaysia

The past several months have seen several announcements by the Malaysian Medical Device Authority (MDA). First launched in mid-2013, the online Medical Device Centralized Application System (MEDCAST) was expanded to support in vitro diagnostic (IVD) device submissions in May 2014. The MDA released directions for a 12 step IVD registration procedure.

Also in May 2014, the MDA issued 5 new policy circular letters to further implement the Medical Device Act:

  • Licensing for establishment as authorized representative and establishment undertaking multiple activities
  • Conformity assessment procedures for medical devices approved by recognized countries
  • Exemption of certain medical devices from registration requirements
  • Medical devices for export and transit
  • Certification of good manufacturing practice (GMP) for the purpose of obtaining establishment license

For Western companies, one of the most important announcements concerned conformity assessment requirements. When registering most medical devices in Malaysia that are currently marketed in certain countries — like the U.S. or Japan — only a simplified assessment by a conformity assessment body in Malaysia is required. The MDA also released a list of low-risk medical devices exempt from registration. However, the MDA should be notified of these devices before they can be sold in Malaysia.

In June 2014, the MDA released a revised device application guidance document, with minor procedural changes. Separately, the MDA’s requirement for domestic medical device establishment licensing became effective on June 30, 2014. While this only affects Malaysian establishments, distributors and authorized representatives, it is important to make sure that your Malaysian distributor or representative has obtained the appropriate establishment license in Malaysia — and is following the updated device registration guidelines.