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SS620:2016 Good Distribution Practice for Medical Devices

What is the Singapore Standard SS 620:2016?

Replacing the TS-01 Good Distribution Practice for Medical Devices (GDPMDS) Revision 2.1, SPRING Singapore developed the SS 620:2016 requirements in collaboration with the Health Sciences Authority (HSA) and Singapore Manufacturing Federation. Approved by the Biomedical Standards Committee, it is a certification standard that focuses on the requirements for distributors and importers to ensure the quality and integrity of the medical devices throughout the distribution process for all medical devices and In-Vitro Diagnostic devices and software (IVD). With new clauses involving premises and facilities and the reorganisation of clauses to guarantee the orderly progression of the QMS, an extensive range of procedures and instructions has been structured to meet the internal and external considerations of an organisation.

Steps to SS 620:2016  certification

Before becoming SS 620:2016 certified, an audit of the management system documentation will take place. An auditor will then conduct an on-site audit of the premises and facilities, resource management, management responsibility, materials control, and more. After certification, a yearly surveillance audit will be conducted for its renewal or maintenance.

Why is SS 620:2016 crucial for your business?

With inevitable risks involved in medical devices and IVD related activities such as contamination, adequate control must be in place to ensure that the quality and integrity of these devices are not affected. Thus, it is recommended that distributors comply with the Good Distribution Practices to meet marketing authorisation requirements or product specifications. By conforming to the SS 620:2016 requirements, the certification acts as validation to consumers that the organisation possesses a QMS and takes responsible measures to comply with applicable laws.

Benefits of the SS 620:2016

From ensuring accuracy in documentation to hiring personnel with a high level of competency for the proper execution of tasks involving medical materials, the SS 620:2016 ensures that a quality distribution system is in place. Regardless of the size, type and scope of your business, SS 620:2016 can benefit your organisation in the following ways:

  • Ensuring consistent medical products or service quality
  • Increase in consumer confidence due to quality enhancement
  • Continuous compliance with regulations leading to an undisruptive workflow
  • Increased efficiency and productivity with a well-managed QMS, thus optimising the supply and distribution chain
  • Ability to attain an Importer or Wholesaler’s license from HSA Singapore

Is the SS 620:2016 Certification Right for your Business?

The SS 620:2016 will replace the HSA Good Distribution Practice for Medical Devices – Requirements, Revision 2.1 (HSA GDPMDS TS-01, R2.1) as the certification standard from 9 November 2020 onwards. Therefore, for companies certified to GDPMDS TS-01 Rev 2.1, it is pivotal to embark on the transition process before the expiration of the old standard.

A mandatory requirement in the application of an importer’s or distributor’s licence, this certification must be attained if an organisation:

  1. Is new and plans on importing, trading, storing, assembling, or distributing medical devices and IVDs and attaining a dealer’s license by the HSA
  2. Has a quality management system and wishes to comply with and implement processes based on the new QMS standard in Singapore
  3. Is currently certified to the GDPMS TS-01 Rev 2.1, which will not continue to be recognised and audited after the 8th of November 2020

What can CCIS do for you?

CCIS provides consultancy services to help organisations bridge the gap and meet the requirements of SS 620:2016. Our team of consultants will ensure the smooth implementation of the GDPMDS Standard and guide your organisation to obtaining the SS 620:2016 organisation with the necessary training, consultancy, and audits. Our methodology includes development, implementation, and performing a third-party internal audit.

Get in touch with CCIS now

If your organisation is looking to apply for the HSA dealers’ license to be the approved distributor of medical devices and be SS 620:2016 certified, contact us today for a no-obligation quote!

For more information on our training and consulting services, drop us an email at [email protected] or call +65 63760550.

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