CERTIFICATION

GDPMD
ISO 13485
ISO 9001
Overview

Regulatory requirements for medical device safety & performance. It shall be implemented and maintained by an establishment in carrying out activities in medical device supply-chain to comply with Malaysian medical device regulatory requirements as stipulated in Medical Device Act 2012 (Act 737).

Benefit

To medical device Authorised Representatives, distributors and importers.

Recognition

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Others

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Overview

International standard represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices. It includes the legal manufacturer and own brand labeller (OBL).

Benefit

To medical device manufacturer and own brand labeller (OBL).

Recognition

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Others

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Overview

International standard that specifies requirements for a quality management system (QMS). Organizations use that standard to demonstrate the ability to consistently provide products and services that meet customer and regulatory requirements.

Benefit
  • Suitable for both small and large organizations.
  • Better internal management.
  • Increase in efficiency, productivity and profit.Improved customer retention and acquisition.
  • Consistent outcomes, measured and monitored. Globally recognized standard.
  • To new invented medical devices or any medical devices without the recognized pre-market approvals eg. EU countries, US FDA, MHLW Japan, Canada Health or TGA Australia.
  • To all medical devices that pre-market approved by the recognized body eg. EU countries (EC/ CE marking), US FDA, MHLW Japan, Canada Health or TGA Australia).
Recognition

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