Medical device import and distribution business has been on an upward trend, with an estimate of over 1300 Singapore companies till date. Since 2010, if you are dealing with medical devices import and distribution in Singapore, you need to be licensed by the Health Sciences Authority (HSA). As part of the licensing requirements, you need to put in place a system within your company to show that the quality of the medical devices is well maintained throughout the supply chain.
This quality system is called the Good Distribution Practice for Medical Devices, GDPMDS in short.
This implementation is important because as a consumer, you definitely do not want to land a counterfeit or sub-standard (expired, damaged) medical devices in your hand without knowing it. The impact to one’s health can be detrimental.
Moving from a Guidance Document to a Singapore Standard
With continuous industry feedback over the years, a Singapore Standard was published in November 2017 – SS 620. This is led by the Working Group on GDPMDS and under the direction of the Biomedical Standards Committee.
Several plus points to note about the new SS 620:2016:
- Aligned to international standards’ structure and terminology, such as the ISO 13485. If you want to adopt this standard and be a Product Owner in the future, you are already 1 step closer.
- Take your business beyond Singapore. You are ready to go regional. Malaysia has a similar requirements in place know as the GDPMD. Other ASEAN countries will put in place such structure very soon. In all cases, complying with SS 620 means you are ready to scale your business to the region.
Moving forward, you should start complying with the new SS 620:2016.
How Stendard First™ can help.
In less than 3 weeks’ time, we are launching for SS 620. If you are on HSA GDPMDS (TS-01), great news! It isn’t as difficult that you need to hire/engage someone to help, but it’s not that straightforward either. Leverage on our software Q&A to customise an updated set of documents to comply with the new requirements – all in less than half a day.
If you are just about to get into the business, it’s straightforward for you – Use Stendard First™ to help you comply with the requirements while you focus to startup your business.
As part of our pre-launch, we are keeping this service for free, based on a limited period.
Request for an invitation now (scroll up) and our team will be in contact with you right after this.