Medical Device Regulations 2012, the subsidiary legislation under the Medical Device Act 2012 (Act 737), has been approved by the Minister of Health and has been published in the Gazette and official enforce on July 1st, 2013. As such, all medical equipment are regulated and subjected to mandatory MDA registration accordingly to subsection 79(2) of the Medical Device Act 2012 [Act 737], dividing into 4 categories; Class A, B, C and D respectively.
Each of the local importer/Distributor shall obtain register for license and obtain Good Distribution Practice (GDPMD) from MDA recognised Certification Assessment Body (CAB). For class A devices, the lead time for approval is estimate at 2 months and Class B, C, D shall be around 6 – 8 months.
For more information, please contact G&M Compliance, Inc. at 714.628.1020