Nov 12, 2015

The Malaysian Medical Device Authority (MDA) has published draft guidance on new medical device labeling rules as well as mandatory problem reporting based primarily on European Union labeling requirements.

MDA labeling requirements

According to an initial Emergo analysis of the MDA labeling guidance, many of the proposed Malaysian device labeling rules are based on European requirements. Furthermore, the guidance introduction states that harmonization of labeling rules across markets would benefit patients, manufacturers and regulators, so clearly MDA officials devised their rules without trying to reinvent the wheel in terms of labeling for the Malaysian market.

Still, there are some areas where Malaysian regulators’ labeling requirements warrant additional attention from manufacturers:

  • The term “Registered with MDA” must appear on the label
  • MDA labeling compliance may be achieved after importation to Malaysia (placing a sticker on a device after importation, for example)
  • The MDA will allow electronic labeling
  • Authorized Representative name and contact details must be included on labels
  • Labels for home-use devices must include clauses advising users to consult with physicians
  • Specific labeling instructions for unregistered devices shipped to Malaysia for demonstration or education purposes

Reporting requirements

The MDA’s guidance on reporting appear to be modeled even more closely on European regulations, particularly MEDDEV 2 12-1. The rules apply to medical devices, establishments and users in terms of post-market incident reporting obligations.

Emergo will provide further analysis of this guidance to determine whether any requirements deviate significantly from European reporting rules, and how that may affect Malaysian medical device registrants.

Additional Emergo resources on Malaysian registration requirements include our regulatory process chart and a four-minute video overview of the MDA approval system.


  • Stewart Eisenhart