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Medical Device Indutry Assessment


What is Product Verification?

Starting from 1 July 2013 when Act 737 comes into effect, all medical devices to be placed in the Malaysian market are required to be registered under the Act before it can be imported, exported or place in the market. For the purpose, an application for the registration of a medical device must be made according to the requirement under Act 737 and in the manner determined by the Authority in Medical Device Regulation 2012.

The persons responsible for registering a medical devide under Act 737 are:-
1. The manufacturer of medical device as defined under Act 737.
2. The authorised representative of the foreign manufacturer, as defined Section 2 of Act 737.

Benefit

Our future client's should implement ISO 9001 if:
1. There is a need to assess and show that the organisation is consistently capable of providing products and services that meet customer requirements and comply with all relevant statutory and regulatory requirements.
2. There is a need to demonstrate that the organisation can enhance customer satisfaction because it is consistently capable of continually improving both its products and services and its practices and processes.