Malaysia Tightens Medical Device Regulations

In short

Here’s an item that stands out from the crowd, but which at the same time reflects the ever increasing global focus on medical device regulations. In this case it’s Malaysia, who’s Health Minister Datuk Seri Liow Tiong Lai has announced new controls over devices in order to protect his population from what Mr Liow calls “fly-by-night or sub-standard manufacturers.”

Background

We’re reporting on coverage from Malaysia’s “Sun Daily” news sheet in which an article was published yesterday detailing the measures to be introduced by the Malaysian government specifically intended to tighten medical device regulatory controls. The article says that “Under the recently gazetted Medical Device Act 2011, a Medical Devices Authority will be formed as a regulatory body to register such devices, and to monitor manufacturers and importers for quality compliance.”

The interesting thing is that the two basic tenets of the legislation are that regulations will be tighter for higher risk devices, which is no great surprise, and secondly that “Devices which fall under the medium-high or high-risk categories will have to register with the authority, who will ensure that the products adhere to strict standards.” … although those standards have not yet been laid out.

What has been flagged is the fairly clear intention to base regulatory approval on evidence, without which devices will be pulled off the market.

What has also been communicated is the threat of a sizeable fine, or imprisonment, or both, for makers or importers who fail to register.

Anyway, you can enjoy the article here.

Source: Malaysian TheSunDaily