SS 620:2016 (2021) Good Distribution Practice for Medical Devices
In Singapore, organizations that are involved in the import, scope, distribution, installation, servicing, and secondary assembly of medical devices are required to obtain SS 620:2016 Good Distribution Practice for Medical Devices certification prior to applying for Importer’s or Wholesaler’s Licence with the Health Sciences Authority (HSA).
What is SS 620:2016 (2021) Good Distribution Practice for Medical Devices?
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SS 620:2016 Good Distribution Practice for Medical Devices was developed by SPRING Singapore under the Singapore Standardization programme for organizations who are involved in wholesale and/ or importation of medical devices in Singapore as it is mandatory to have SS 620 GDPMDS certification prior to applying for an importer or wholesaler license with the Health Sciences Authority of Singapore (HSA).
SS 620 specifies the requirements for distributors and importers to implement a quality management system that focuses on ensuring the safety, quality and performance of medical devices throughout the distribution process.
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Benefits of SS 620:2016 (2021) Certification
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Enhance customer confidence - Maintenance of medical device quality throughout the distribution network,
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Compliance to regulatory requirements for import and wholesale license,
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Improved company’s branding,
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Increase productivity and efficiency with an effective quality management system.
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Enhance customer confidence - Maintenance of medical device quality throughout the distribution network,
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Compliance to regulatory requirements for import and wholesale license,
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Improved company’s branding,
-
Increase productivity and efficiency with an effective quality management system.
Why get certified with SOCOTEC Certification Singapore?
SOCOTEC Certification Singapore is accredited by Singapore Accreditation Council (SAC) for SS 620:20216 (2021) for all activities and scope of medical devices, and we are able to assist with the upgrading from SS 620:2016 (2021) to ISO 13485:2016 Quality Management System for Medical Devices.
Key steps to certification
