Medical Device Global Market: Expanding into Asia-Pacific (APAC)
Daniel English, Regulatory Affairs Consultant at IMed Consultancy provides valuable insights in this first short article of a 3-part series.
Are you a UK or EU Manufacturer with a medical device already approved in the UK or EU? Have you recently CE Marked a lower risk class Medical Device and you have wondered whether you could expand and sell into the rest of world market? Then this article is for you.
Medical Device Global Market Expansion -Are you making the most out of your portfolio?
Here we offer a brief look at some of the economic areas with the most potential. This short article will provide an overview of those classification systems, requirements and regulatory pathways which often have commonality with other countries within the same region.
The Asia Pacific area has some of the world’s most populated countries making up over 60 percent of the global population. Market data Forecast states that the APAC medical device market is worth over 105 billion (USD) in 2022 with estimate growth expected to hit nearer 150 billion (USD) by 2027. The APAC regions also has some of the more developed and thorough Regulatory agencies, as seen in Australia, Japan and Singapore. The latter of these markets is generally considered as one of the more accessible ways into the region for a foreign medical device manufacturer, with a user-friendly requirement and registration process and regularly updated guidance.
Expanding into Singapore: SMDR
Medical devices in Singapore are regulated by the Medical Device Branch of the Health Sciences Authority (HSA) and all registered medical devices are listed (and publicly available) on the Singapore Medical Device Registered (SMDR). Foreign medical device manufacturers must appoint a Legally Responsible Person (LRP) as their registrant to submit device applications and represent them to the HSA.
Classification system in Singapore for Medical Devices
The Classification system ranges from Class A (Low) to D (High) and generally aligned with the EU. For example, a class IIb EU device is generally a Class C (Moderate-high risk). You will be required to classify your product against the comprehensive HSA guidance (GN-13: Guidance on the Risk Classification of General Medical Devices) before you begin the registration process.
Devices considered to be low risk Class A do not require a registration approval pathway and a Class A exemption can be completed in the online MEDICS system.
Once you have identified your device risk classification you can look to the possibility of device grouping which can allow similar devices to be registered in a single submission (The HSA has guidance on the grouping of devices).
Medical Device risk classification
The Evaluation Route your device will depends on its Risk classification, duration of safe marketing history and prior approval of your device by any of the HSA recognised reference agencies (EU Notified Bodies, US (FDA), Health Canada (HC), Japan (MHLW) and Australia (TGA). The evaluation route of your device will also determine the approval time, fees and documentation needed for registration. The assessment routes for a medium to high-risk devices range from the Full Route for devices which have no prior approval by any of the above reference agencies and the Abridged Route for those devices which have received prior reference agency approval(s). Other routes are available (with some exceptions) for products with a robust history in the market, details of which can he found here. The required technical dossiers are based on the ASEAN Common Submission Dossier Format (CSDT), while documentation from a European (MDR) technical file can be used to satisfy many of the required documentation demands.
Things to consider when placing a Medical Device on the Singapore Market
- How to appoint a Local Authorised Representative (LAR): a letter of Authorisation is required from the manufacturer stating all product/devices covered.
- The (LAR) is your registrant and representative in Singapore and controls your device registration, so chose a registrant with an established relationship with the HSA.
- Multiple registrants can be authorised, however the each must register the device again as a new device application.
- All registration submissions are made via the online Medical Device Information and Communication System (MEDICS)
- The HSA Pin allows access the MEDICS system outside of Singapore. Your LAR can provide this Pin to allow you to access and check up on the process.
- Special Access routes are available to enable qualified practitioners to access unregistered medical devices for use on their patients (more information here).
Also please look out for Part 2 of this global expansion review where we will look at the Middle East and North Africa region.
Regulatory Affairs Consultant