December 17, 2019
MDA has introduced a revision to the Circular Letter No 1 of Year 2019: Post-Market Responsibilities for Manufacturer and Authorized Representative. This Ciruclar Letter essentially discusses all the duties and obligations which fall upon local manufacturers and local authorized representatives, after placing devices on the market.
In the revised CL issues recently, clause (8) reiterates that if a body corporate commits an office under the Medical Device Act 2012 (Act 737), any person who at the time of commission an offence was a director, manager, secretary, or other similar officer of the body corporate may be charged severally or jointly. When the body corporate is found guilty of the offence, they shall also be deemed guilty of that offence.
Circular Letter No. 1 Y 2019 (Revision 1): Post-Market Responsibilities for Manufacturer and Authorized Representative
Malaysia; MDA; Establishment Responsibilities