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Internal Auditors Training

Good Distribution Practice for Medical Devices (GDPMDS)

SS 620:2016 Quality Management Systems

What is Quality Management?

From achieving quality policies to meeting regulatory and customer requirements, a Quality Management System (QMS) instils confidence in an organisation’s ability to perform and improve on a continuous basis. With the exceeding customer expectations and stringent standards set for quality assurance, there is an increased demand for a companies’ QMS to excel and deliver. Therefore, a robust QMS that caters to an organisations’ business needs is vital in assuring that a company can provide quality products and services in an efficient and authorised manner.

What is the Singapore Standard SS 620:2016?

Replacing the TS-01 Good Distribution Practice for Medical Devices (GDPMDS) Revision 2.1, the SS 620:2016 requirements were developed by SPRING Singapore 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 orderly progression of the QMS, an extensive range of procedures and instructions has been structured to meet internal and external considerations of an organisation.

Steps to 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 Important for your Business?

Given the inevitable risks, such as contamination involved in medical devices and IVD related activities, adequate control must be in place to ensure that the quality and integrity of these devices are not affected. It is thus 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 of an organisation’s possession of a QMS that responsibly takes 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, a list of the SS 620:2016 benefits include:

  • Ensuring consistent medical products or service quality
  • Increase in consumer confidence due to quality enhancement
  • Continuous compliance with regulations leading to an un-disruptive 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 ISO 41001 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.

Being 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. The CCIS team of consultants will help ensure the smooth implementation of the GDPMDS Standard and be SS 620:2016 certified with the necessary training, consultancy, and audits. Our methodology includes development, implementation, and performing a third-party internal audit.

Get in Touch

If your organisation is looking to apply for the HSA dealers’ license for the approved distribution 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 query@ccis.com.sg, or call +65 63760550.

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