Introduction to SS 620 - Medical Device Good Distribution Practice (GDPMDS)

As you aim to achieve recognition and access to the Singaporean medical device market, consumer trust can be won through the assurance of having a proper SS 620 certified system in place.

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Introduction to SS 620:2016 – Medical Device Good Distribution Practice (GDPMDS)

Our experienced team of in-house ISO consultants can plan and guide you through this process smoothly, covering critical areas for your company, as follows, to ensure you are well-established.

What is Medical Device Good Distribution Practice (GDPMDS)?

GDPMDS is a set of Singapore Standards for Good Distribution Practice for Medical Devices (Gdpmds) awarded by the Singapore Accreditation Council (SAC). If you are storing, importing and distributing medical devices prior, you would have probably heard of the Good Distribution Practice for Medical Devices (Gdpmds).

While exact requirements differ slightly between different countries, it serves as a guide on companies’ quality management system 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.

SS 620 is a highly recommended standard for organisations who are looking to gain market authorisation for their medical devices in Singapore.

Potential benefits for companies with SS 620 certification

The SS 620 certification (gdpmds) aims to ensure that companies dealing with medical devices have a quality management system in place. The purpose of these quality management systems is to streamline the supply chain, ensuring that the quality and integrity of the medical devices is maintained throughout the storage and distribution process, thus providing quality assurance while safeguarding consumers interest and enhancing their confidence level.

It is commonly agreed that companies within the medical device industry will be subjected to strict external and internal audit. This kind of scenario makes SS 620 certification (gdpmds) even more vital because it serves as quality manuals for companies. Such assurance from the certification can also ensure clear and timely documentation when the time arises for an audit to be conducted.

Having a robust set of practice for medical devices is essential to companies dealing with this kind of product because the confidence that consumers get from the certification will indirectly affect companies’ profits and revenues.

How do I apply for Medical Device Good Distribution Practice certification? (GDPMDS)

If you are looking to get yourself SS 620 certified, here are the steps which will help you in your certification process:

You must first identify which standard applies to your company, in this case, it would be the SS 620 certification. It is highly recommended that you engage a qualified professional consultant to cooperate with you in this process.

Gaining knowledge on the various requirements and clauses within the SS 620 standard is vital to ensuring a smooth audit.

Together with your SS 620 consultant, you must ensure these criteria are met:

• Ensure medical devices’ design and development work is thorough
• Ensure comprehensive coverage of medical devices’ production and manufacturing activities
• Ensure that distribution channels for the medical devices, while extensive, are well-managed
• Ensure that there are proper failsafe and control systems in place to respond to any potential risks or hazard
• Ensure that all appropriate procedures are well documented and consistently stored

Holistically speaking, you must have a robust quality management system specifically targeted at gdpmds requirements.

To achieve the SS 620 certification, you must ensure the competency of your team regarding SS 620 standard and requirements through the conduct of training courses. Next, the consultant will work together with you in crafting and performing an initial internal audit with your team to ensure the effectiveness of your quality management system in preparation of SS 620 certification.

Note that a yearly surveillance audit will be conduct to maintain the certification thus it is crucial that your systems are robust and there must be suitably qualified personnel to consistently maintain the standards.

Lastly, finding an accredited certification body to certify your processes through the mandatory audit would enable you to be SS 620 certified.

Conclusion

To conclude, we have summarised the background of the SS 620 certification, the various benefits of being SS 620:2016 certified and how being certified can improve customers’ confidence, profits and revenue and also how you can get your organisation SS 620 certified.

Why choose Stendard?

Stendard can provide you with a one-stop consultancy service. At Stendard, we believe that quality is everyone’s business because it takes a team to consistently deliver and uphold excellent standards that build confidence with customers, partners and the community.

We are a regulatory consultancy and technology company that helps businesses implement international standards, streamline business processes across the organisation, and accelerate global growth.

With our vast range of consulting services, feel free to contact us, and we at Stendard will be glad to assist.