We often receive requests for registering a low-risk medical device in Singapore.
Here is in a Nutshell what You Need to know
Singapore has four (4) different risk classes for medical devices:
(a) Class A (low risk);
(b) Class B (moderately low risk);
(c) Class C (moderately high risk); and
(d) Class D (high risk).
A Class A registration is relatively easy, while Classes B, C, and D require a more thorough registration process with HSA, which is the local government agency that is in charge of protecting and advancing national health and safety.
For low-risk medical devices that fall into class A, there is a simplified process that requires a local company in Singapore that is responsible for placing that medical device in the local market. This company has to initiate parallel product registration and dealer license application steps for that specific medical product.
Before registering the respective medical product, it is
compulsory to verify whether the product complies with the official
requirements by doing a classification step. HSA has provided a
simple online pre-classification tool that allows you to check
instantly whether your medical product falls into class A,
here
https://www.hsa.gov.sg/medical-devices/registration/is-it-a-medical-device
There is also an online database for Class A medical devices, click here (search for "Dr. Storz" as the owner and you will receive a few thousand hits)
And there is a quick guide for registering the product and the local responsible company, here https://www.hsa.gov.sg/docs/default-source/hprg-mdb/quick-guide-to-md-registration-and-licensing_may-2021.pdf
Example 1: Hospital Bed
As an example, that is what you do if you have a medical product in the form of a hospital bed that you want to import into Singapore: you first classify your product with the online tool, here https://www.hsa.gov.sg/medical-devices/registration/is-it-a-medical-device.
You answer all the qualifying questions with "no" and the online tool will tell you that your hospital bed is "unlikely to be a medical device" (you can download the document here if the link above is dead hospital bed online result), and you will be directed to a set of slides that explains the differences between medical devices and non-medical devices, here https://www.hsa.gov.sg/medical-devices/registration/is-it-a-medical-device (you can download the document with the slides here if the link is dead: medical-devices-product-classification-guide).
Please don't be scared, this uncertainty is normal if you deal with the gray area of medical devices. You need proper guidance from an experienced attorney with an engineering or science degree and with knowledge of the relevant law for making the final decision to classify your medical device in Singapore.
Let's assume that this classification expert classifies your hospital bed as a "Class A" medical device.
The next step is filing the applications with HSA. Please note that this will incur some official fees.
After requesting registration, HSA will either raise objections or right away issue an official notification of the registrations. It is recommended to double-check the registrations by comparing them with what has been requested.
The final step is to docket and monitor the renewal deadlines for the registrations, plus initiating the renewals once they become due.
Example 2: A Laptop For Logging Heartbeat Measurements from an Existing Heartbeat Monitor
If you have a medical product in the form of a laptop for logging heartbeat measurements from an existing heartbeat monitor then it is more complicated. There is a cable between the laptop and the heartbeat monitor and it is not clear what is done over that cable. The online tool will tell you that your laptop with a connection cable is a medical device because you have to answer the question "Is your product intended for the diagnosis, prevention, monitoring, treatment or alleviation of any disease?" with "yes" (you can download the document here if the link above is dead laptop online result).
The online tool will then direct you to the risk classification tool to find out the risk class of your medical device. This is where it gets tricky. The online tool will ask you whether the device is an active medical device. You find a difficult definition there, that you need to answer with "I am not sure". This means that your answer will be "yes" in this context, to be on the safe side. The next question is "Is the device an active therapeutic device intended to administer or exchange energy to or with the human body, or is a software?". And you would again need to answer "I am not sure", which means "yes" in this context, to be on the safe side. The result is that your laptop is considered to be "Class B" (see here laptop with unclear cable connection). But there are chances that the laptop can be classified as "Class A", depending on answering the above unclear questions.
For example, if the cable connection is a pure reading line that reads out the data from the heartbeat monitor and if this cable is neither used for transmitting information nor for transmitting energy to the existing heartbeat monitor, then the laptop is a "Class A" medical product (see here laptop reading data from heartbeat monitor).
Again, please don't be scared, this uncertainty is normal if you deal with the gray area of medical devices. You need proper guidance by an experienced attorney with an engineering or science degree and with knowledge of the relevant law for making the final decision to classify your medical device in Singapore. Follow this website https://www.hsa.gov.sg/medical-devices/registration/requirements and there is a useful website (click here) that leads you even deeper into the subject matter of classifying your medical device.
Let's assume that this classification expert classifies your laptop as a "Class A" medical device.
The next step is filing the product registration and dealer license applications with HSA. Please note that this will incur some official fees.
After requesting registration, HSA will either raise objections or right away issue an official notification of the registrations. It is recommended to double-check the registrations by comparing them with what has been requested.
The final step is to docket and monitor the renewal deadlines for the registrations, plus initiate the renewals once they become due.
And that is it?
Of course, that is not all. Upon importing a medical product into Singapore, the importing company must make sure that the imported medical device complies with what has been registered. Regular random sampling and tests are required, followed by proper documentation. In fact, a Quality Measurement System (QMS) according to a recognized standard such as ISO 13485 has to be in place.
And what Happens if I am Selling my Medical Products without Proper Registration or if my Medical Products are Different from What has been Registered?
This is not good at all. Your products will be seized. All people involved may get fined and/or go to jail.
Check out this link for more information on that:
http://bit.ly/SG-illegal-products-HSA
By the way, the same applies if you make a wrong statement when registering your medical device with HSA. Being registered, there is still no guarantee that the medical device complies with the official requirements. The actual importer, dealer or wholeseller of the respective medical device and his helpers are still liable for that.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.