ISO 13485

 

The standard provides a framework for a comprehensive management system for the design and manufacture of medical devices.

Its primary objective is to facilitate harmonized medical device regulatory requirements. ISO 13485 contains requirements that are essential for any organization operating at any tier in the medical device and pharmaceutical supply chain.

 

It is especially relevant to manufacturers who wish to demonstrate applicable regulatory requirements, and by organizations whose services support medical device manufacturers.

 

Key Benefits:

  • Ensure regulatory compliance and reduce liability

  • Competitive marketing advantage

  • More effective risk management and quality assurance

  • Improve overall performance and reduce costs

SS 620:2016 Good Distribution Practice for Medical Devices (GDPMDS)

 

Hospital and clinic patients as well as the public in Singapore will be assured that the medical devices used to treat them are properly certified and distributed under licence.

 

The Singapore Accreditation Council (SAC) recently launched the accreditation scheme for the certification of Good Distribution Practice for Medical Devices in Singapore (GDPMDS) since year 2008.

This scheme was introduced to support the Health Sciences Authority (HSA) of Singapore in implementing its Health Products Act 2007 which requires medical devices to be regulated according to the supply/distribution chain (manufacturer, importer and wholesaler), product registration and advertising & promotion.

Under the Health Products Act 2007, medical devices are the first product group to be regulated.

The key areas of regulatory control include:

  • Supply/distribution chain (manufacturer, importer and wholesaler)

  • Product registration

  • Advertising and promotions

 

Key Benefits of Accreditation

Besides supporting HSA to implement its regulation, the scheme will provide third party assurance that certification bodies are competent in providing certification for GDPMDS. SAC accredited certification will in turn help to ensure the quality and integrity of medical devices throughout the distribution process.

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