By June 30, 2015, foreign medical device manufacturer products must be on Malaysia’s transition list to be sold in Malaysia.
In addition, in February of 2015, the Malaysia Medical Device Authority (MDA) published a draft guidance for a proposed system of post-market surveillance regulatory audits for medical device manufacturers. There are two proposed types of audits: “proactive surveillance audits” and “for-cause audits.” The government can initiate these audits for a variety of reasons, including legislation changes, product complaints and other concerns regarding post-market vigilance.
Prior to a proactive audit, the device manufacturer will be given at least a two week notice in a confirmation letter from the MDA. This letter will also include a list of areas that the audit will cover. Generally, no notice will be given in advance for a for-cause audit.
Before the audit, specific information may be requested from the manufacturer, including details of the Conformity Assessment Body and a manufacturing flow chart. Any non-compliance found during the audit will result in the development of a corrective action plan with a specified timeframe for completion. The MDA may require the manufacturer to submit evidence of completion.