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ISO 13485 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.
Good Distribution Practice for Medical Devices
The 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
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 All medical devices under categories Class B, C and D required to undergone conformity assessment by way of verification conducted by the conformity assessment body registered under section 10 of Act 737.
(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 All medical devices under categories Class B, C and D required to undergone conformity assessment by way of verification conducted by the conformity assessment body registered under section 10 of Act 737.
Full Conformity Assessment
Full Conformity Assessment (FCA) is th technical term given to the process of evaluation
and approval. In the context of medical device regulatory system, it is a systematic
examination of evidence generated and proce dures 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 therefore
conforms to Essential Principles of Safety and Performance (EPSP) for Medical Device.
- Benefits
Our future client's should implement ISO 9001 if:
- 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.
- 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.
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