Home About Qualtech NEWS MALAYSIA: Circular Letter No. 1 Year 2019: Post-Market Responsibilities for Manufacturer and Authorized Representative (AR) - June, 2019
MALAYSIA: Circular Letter No. 1 Year 2019: Post-Market Responsibilities for Manufacturer and Authorized Representative (AR) - June, 2019

June 11, 2019

Placing a medical device in the market upon registration requires consistent monitoring and vigilance to ensure its safety and efficiency are controlled. However, unmonitored medical devices tend to still be in the Malaysia medical device market, due to a number of situations, namely:

(a)    Authorized Representative (AR) closed its business and no replacement is arranged to look after the medical device post-market vigilance

(b)    AR closed its business after placing medical device in the market and being replaced by another AR

(c)     Manufacturers closed their business and did not arrange for any replacement after placing medical device in the market.

It is evident that if these situations persist, there will be a surplus of unsupervised medical devices in the market, with no one to be held accountable for and endangering public lives. Complaints, incidents and recall of medical devices will not be take care of properly.

Thus, in the interest of public health and safety, MDA is implementing the following enforcement control of post-market responsibility for manufacturers and authorized representatives:

(a)    AR closed its business and no replacement is arranged to look after the medical device post-market vigilance

✻  Until a replacement is found, the out-of-business AR shall be responsible for post-market issues at least in accordance with the projected useful life of the medical device as determined by the manufacturer.

(b)    AR closed its business after placing medical device in the market and being replaced by another AR

✻  The newly appointed AR shall be responsible for post-market issues of the medical device.

(c)    Manufacturers closed their business and did not arrange for any replacement after placing medical device in the market.

✻  Even though they may be out of business, the manufacturer shall be responsible for post-market issues at least in accordance with the projected useful life of the medical device as determined by the manufacturer.

All local and foreign medical device manufacturers interested in penetrating Malaysia medical device market have to take the above into consideration and find ways to effectively manage their devices’ post-market activities, until the projected useful life expires.

 

References:
Circular Letter No. 1 Year 2019: Post-Market Responsibilities for Manufacturer and Authorized Representative (AR)

Tags:

Malaysia medical device; post-market vigilance

 

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Home About Qualtech NEWS MALAYSIA: Circular Letter No. 1 Year 2019: Post-Market Responsibilities for Manufacturer and Authorized Representative (AR) - June, 2019