Malaysian Agency Plans New Regs On Medical Device Recalls
This article was originally published in PharmAsia News
Executive Summary
The Malaysian Medical Device Authority is planning a new draft guideline that explains the processes that medical device companies should put in place to initiate a voluntary product recall, or to deal with a recall ordered by the regulator.
A new draft guideline from the Malaysian Medical Device Authority is designed to help manufacturers comply with the provisions of the Medical Device Act 2012 (Act 737) and its supporting regulations that are still in the process of being implemented.
In addition to explaining processes for initiating a voluntary recall, the guideline clarifies that the MDA has the right to suggest and also order product recalls in cases where a device poses a high public health risk.
The guideline states that while the concerned device establishment – a term that includes manufacturers, importers and distributors – is solely responsible for undertaking the necessary corrections, the MDA would also monitor the entire rectification process until all faulty products are removed from the market or are corrected.
The MDA requires device establishments to have a documented standard operation procedure (SOP) in place to undertake effective and timely recalls. The guideline includes an annex outlining the possible elements that could be included in a recall SOP.
Two other annexes in the guideline deal with the formats that device establishments should follow when notifying all concerned stakeholders and the MDA about the recall. In both cases, the notification has to be provided before, or upon, initiating the recall. If the concerned device is being exported to other countries, the device establishment is also required to notify the foreign authorities about the recall.
In addition, device establishments are required to submit to the MDA a preliminary report specifying the anticipated closure date of the recall. For Class I recalls (posing the highest-risk), the preliminary report has to be submitted within 48 hours of the recall being initiated, for Class II recalls (medium-risk) within three working days and for Class III recalls (low-risk) within five working days.
A final report would have to be submitted within 30 days of the recall being completed, and this should include the results of the recall and any action taken to prevent the recurrence of the problem.
(This article also appears in Scrip Regulatory Affairs
. PharmAsia News brings selected complementary coverage from our sister publications to subscribers.)