GDPMD ( Good Distribution Practise For Medical Device )
As of 1st July, 2013, the Medical Devices Act 2013 (Act 737) was enforce, thus requiring all local authorised representatives (LAR) or any parties involved with import, wholesale, warehousing or distribution of medical devices to obtain an establishment license as required by the Malaysia Medical Device Authority before being able to trade medical devices in Malaysia.
In order to obtain an establishment license, the organization must be certified to GDPMD as a pre-requirement for application. Trading medical devices without an establishment license means you are going against the law and based on the Medical device Act 737 .
The Good Distribution Practice for Medical Devices (GDPMD) is a mandatory certification scheme for all Parties as stated above. GDPMD qualifies organizations that their medical devices are consistently stored, transported and handled under quality condition as required by the standard. The Law is applicable to any larger organization and also to small organization which might be operated by 1 man show which is either operated in the Office or Houses.
GDPMD specifies the requirements for a quality system to be established and maintained by an organization in carrying out activities in the medical devises supply-chain. GDPMD requires an organization to demonstrate its ability to maintain safety and performance of medical devices throughout the supply-chain. It will be used by both internal and external parties to determine the ability of an establishment to meet the requirements specified within.
This system is a great system which will educate the industry players to consistenly monitor the medical device which has been supplied to the customers while ensuring the quality is in place.
For the company which are having 2 companies together we can also merge to documents for your in order to suit your requirement and minimize the papers.
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“ Its Our Duty to Ensure that the GDPMD system is Established In Your Organization “