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: Document Generation (By Stendard First™)
Stendard First™ is a smart generator that helps your organisation create a documentation structure (Site Master File, Procedures, Work Instruction and Forms) to meet the SS 620:2016 requirements.
Using an intuitive Q&A interface, questions are accompanied by layman hints, explanations and guidance. From the answers that you provide, a fully customised set of documents is generated. With just a click of the 'Export' button, gain full ownership of 30+ customised documents in just an instant.
What used to take 4-6 weeks to prepare, is now generated in less than 1/2 day. We tackle the most time consuming process for you.
+ Stage 2: Training (By Stendard)
Training is usually conducted in collaboration with our professional partners. This can include a general Standard Awareness Training or a more in-depth Internal Audit Training. We recommend at least one of your team mates to go for an Internal Audit Training, so you can be self-sufficient and able to perform your own internal audit.
+ Stage 3: Document Implementation (By you)
After you have generated your documents via Stendard First™ and have completed your training, you can finalise all the content details and get ready for implementation.
Upon implementing your QMS documents, it is time to start following the procedures and using the forms day-to-day.
+ Stage 4: Internal Audit (By you)
Based on the audit checklist generated via Stendard First™, your team will conduct an internal audit. The purpose is to make sure that everyone in your team is familiar with the documented procedures and are executing it well. Any non-conformance should be detected and recified. This is also a good exercise for everyone prior to the actual audit.
+ Stage 5: Certification (By Certification Bodies)
The final stage of this compliance journey is the actual certification audit. Every SS 620 audit goes in a 3-year cycle - an initial audit followed by 2 years of surveillance audits, and the cycle goes on. Upon successful completion of each audit, the SS 620 Certification is officially yours.