Introduction to Medical Device Good Distribution Practice (GDP)
If you are storing, trading and distributing medical devices, you would have probably heard of the Good Distribution Practice (GDP) before. While exact requirements differ slightly between different countries, it serves as a guide on companies’ QMS for the handling, storage, delivery, installation, servicing, secondary assembly and other related activities (for example, warehousing, logistics and freight forwarding services) of medical devices, including in-vitro diagnostic devices and software.
The aim of this is to ensure that companies dealing with medical devices have a quality distribution system in place. This ensures that the quality and integrity of the medical devices is maintained throughout the storage and distribution process, thus safeguarding consumers and enhancing their confidence level.
Roadmap to SS 620:2016 Certification
The Singapore Standard SS 620:2016 – Good Distribution Practice for Medical Devices - was developed by SPRING Singapore (now Enterprise Singapore) under the Singapore Standardisation Programme. The certification to GDPMDS is a mandatory requirement in the application of an Importer's or Wholesaler's Licence.
Prior to SS 620:2016, the Good Distribution Practice for Medical Devices was known as the HSA GDPMDS TS-01, R2.1. With the change implemented on 9 November 2017, all companies are required to comply with this new certification standard from 9 November 2020 onwards. To aid this transition, Stendard First™ creates the organisation-specific documents that adhere to SS 620:2016 within a day. Companies can implement the standard with ease.
+ Stage 1: Start preparing for the journey. Learn how to with Stendard.
- Gain an overview of regulatory requirements (catered to your business expansion strategy).
- Understand the requirements of the standard and know what quality practices need to be in place.
+ Stage 2: Automate the creation of your QMS documents with Stendard Solution™.
- Stendard Solution™ allows for efficient, automated document generation.
Site Master File and SOPs customised according to certification requirements and your company specifics.
Form templates, ready for immediate implementation.
+ Stage 3: Begin putting your SOPs into practice. Digitalise this with Stendard Solution™.
- Set up your QMS with the implementation of processes.
The team at Stendard is able to support this with a step-by-step run-through of the clauses and SOPs to match your current business practices - tightening processes to be implemented, or modifying draft documents if necessary.
- With Stendard Solution™, maintain an updated, consolidated depository of your team's records, without physical limitations.
+ Stage 4: Perform your internal audit.
- Support from the team at Stendard includes:
Training on how to conduct an internal audit.
Proper diagnostic assessment before your first audit to ensure readiness.
- The Audit module within Stendard Solution™ includes a clause-by-clause checklist to ensure you have covered all the requirements of the standards.
+ Stage 5: Achieve your Certification!
(Given external audit by Certification Bodies)
- Passing your external audit would mean obtaining your SS 620:2016 certification!
- Every SS 620 audit follows a 3-year cycle: an initial audit, with surveillance audits each year for the next two years. After which, the cycle begins again.
- Maintaining your certification would require continued compliance to the standards. With Stendard Solution™, you can easily keep up with it!