About 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 it differs slightly between different countries, it usually serves as a guide on the 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 objective of putting in place a GDP is for the assurance of the quality and integrity of the medical devices throughout the whole distribution process, therefore enhancing the confidence level and safeguarding the consumers.
About Singapore Standard SS 620:2016
The Singapore Standard SS 620:2016 – Good Distribution Practice for Medical Devices - Requirements was developed by SPRING Singapore (now Enterprise Singapore) under the Singapore Standardisation Programme.
Prior to SS 620:2016, the Good Distribution Practice for Medical Devices was also known as the HSA GDPMDS. Starting from November 2017, both new and transition (currently certified to HSA GDPMDS) companies should begin their journey to comply with the new SS 620:2016. With its new rollout, Stendard First™has created a smart generator to help companies adhere to SS 620:2016 quickly and easily.
Roadmap to SS 620:2016 Certification
The Singapore Standard SS 620 : 2016 – Good Distribution Practice for Medical Devices - Requirements was developed by SPRING Singapore (now Enterprise Singapore) under the Singapore Standardisation Programme.
Prior to SS 620:2016, the Good Distribution Practice for Medical Devices was also known as the HSA GDPMDS. With its new rollout, Stendard First™has created a smart generator to help companies adhere to the SS 620:2016 quickly and easily.
+ 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.