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Medical Device Industry Assessment


Good Distribution Practice for Medical Devices

Good Distribution Practice for Medical Devices (GDPMD) specifies that a quality management system shall be established, implemented and maintained by an establishment carrying out activities under requirements of Medical Devices Act 2012 (Act 737). It requires an establishment to demonstrate its ability to maintain the quality, safety and performance of medical while its custody. It is applicable to all parties involved in the supply-chain of medical devices covering authorized representatives of foreign manufacturers, importers and distributors of medical devices in Malaysia.

ISO 13485

Medical Devices - QMS - Requirements for Regulatory Purposes

Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes is an International Organization for Standardization (ISO) standard, was published for the first time in 1996, that represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices.

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 placed in the market. For that 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 device under Act 737 are :-

(i) The manufacturer of medical device as defined in Section 2 of Act 737

(ii) The authorised representative of the foreign manufacturer, as defined in Section 2 of Act 737.

Full Conformity Assessment

Full Conformity Assessment (FCA) is a technical term give to th process of evaluation and approval. In the context of medical device regulatory system, it is a systematic examination of evidence generated and procedures undertaken by the manufacturer, under requirements established by the Regulatory Authority (RA), to determine that a medical device is safe and performs as intended by the manufacturer and, conforms to Essential Principles of Safety and Performance (EPSP) for Medical Device.

“Necessary certification, trade in your target markets, assurance you need anywhere in the world”