The Health Sciences Authority (HSA), Singapore’s regulating agency in the sphere of healthcare products, has published a detailed guidance document describing the most important aspects associated with the registration of medical devices in order for them to be allowed for marketing and use in the country. The latest version of the document was issued in August 2021.
The document is intended to provide an overview of the current regulatory framework and assist medical device manufacturers and other parties involved in complying with the applicable regulatory requirements. However, the document is non-binding in its nature, and in case of any discrepancies with the provisions of applicable legislation, the latter should prevail.
Singapore’s existing regulatory framework for medical devices is based on the Health Products Act and Health Products (Medical Devices) Regulations 2010. Under the general rule, any and all medical devices intended to be marketed and used in Singapore should be subject to prior registration with the regulating authority. The HSA guidance additionally emphasizes the importance of following the regulatory requirements in order to facilitate placing medical devices on the market and avoid undue delays. For instance, in the case of incorrect classification of a medical device subject to review, a new submission would be required.
First, the authority provides the definitions of the most important terms and concepts used in the context of registration of medical devices in Singapore, including the following:
- Intended use stands for the objective intended use or purpose, as reflected in the specifications, instructions, and information provided by the product owner of the medical device;
- Label – any written, printed, or graphic representation that appears on or is attached to the health product or active ingredient or any part of its packaging, and includes an informational sheet or leaflet that accompanies the health product or active ingredient when it is being supplied;
- Product owner stands for a person who (i) supplies the health product under his own name, or under any trademark, design, trade name or other name or mark owned or controlled by him; and (ii) is responsible for designing, manufacturing, assembling, processing, labeling, packaging, refurbishing or modifying the health product, or for assigning to it a purpose, whether those tasks are performed by him or on his behalf.
Apart from those listed above, the document also provides definitions of such terms as “applicant,” “export,” “import,” “manufacture,” “medical device,” “registrant,” “serious deterioration in the state of health,” “sterile state,” “telehealth,” and “wholesale.”
Risk Classification for Medical Devices
Another important aspect addressed in the HSA guidance relates to the applicable risk-based classification for medical devices. According to the guidance, medical devices could be divided into four classes depending on the risks associated with the device, its intended use, and also the measures implemented by the manufacturer to mitigate existing risks. Other factors to be considered when determining the class of a medical device should include the contact duration with the body, degree of invasiveness, whether the medical device delivers medicinal products or energy to the patient, whether they are intended to have a biological effect on the patient, etc. The legislation also provides special classification rules to be applied in the case of products consisting of both medicines and medical devices. In the case of in vitro diagnostic medical devices, the most important factors to be considered should include the intended purpose of the medical device, technical/scientific/medical expertise of the intended user, importance of the information to the diagnosis, and impact of the results to the individual and/or to public health.
Irrespectively of the type of medical device, the risk classes are marked from A to D, where A refers to the lowest risk and D to the highest, respectively.
Registration of Medical Devices
The guidance further describes in detail the procedures to be followed in the course of registration of medical devices in Singapore. As mentioned, the regulatory requirements to which the device will be subject will actually depend on the risks. Prior registration is mandatory for any and all medical devices apart from those explicitly exempted under the current legislation.
- Class A medical devices are exempted from registration due to relatively low risks associated thereto. At the same time, such devices still should comply with the Essential Principles for Safety and Performance for Medical Devices in order to be allowed for marketing and use in the country. The parties involved in operations with such devices are also obliged to follow the general requirements related to medical devices. The authority additionally mentions that Class A medical devices initially intended to be used with other devices as part of a system should be registered together with the system itself.
- Grouping medical devices. For the purpose of registration, medical devices could be compiled into groups. The options available include registration of:
- A single medical device;
- One medical device family;
- One medical device system;
- One medical device test kit;
- One medical device IVD cluster;
- One medical device group;
- One device-specific grouping of hearing aids;
- One device-specific grouping of IHC IVD reagents;
- One device-specific grouping of FISH probes IVD reagents; or
- One device specific grouping of IVF media.
- Telehealth Medical Devices, Devices for Modification of Appearance or Anatomy and 3D-printed Medical Devices. The aforementioned types of medical devices are subject to special regulatory requirements due to their specific features. In this regard, the authority refers to the relevant device-specific guidance documents describing the applicable regulatory framework.
Class B Medical Devices Registration
Due to the increase in risks associated thereto, Class B medical devices are subject to prior registration with the HSA. According to the guidance, there are three pathways to be applied for such devices, namely:
- Full Evaluation Route;
- Abridged Evaluation Route;
- Immediate Class B Registration (IBR) Evaluation Route.
It is stated that second and third pathways could be applied if the device has already been placed on the market in another jurisdiction and thus has a prior safe marketing history. The list of reference regulatory agencies includes Australia’s Therapeutic Goods Administration (TGA), Health Canada, Japan’s Ministry of Health, Labour and Welfare (MHLW), US Food and Drug Administration (FDA), and European Union’s Notified Bodies (EU NB). For the latter, a conformity certification issued under the Directives remains admissible. In order to be eligible for any of the accelerated pathways mentioned above, a medical device subject to review should have prior approval granted by any of the abovementioned reference regulatory agencies.
In summary, the present guidance issued by the HSA provides a detailed overview of the regulatory requirements for placing medical devices on Singapore’s market. The document provides additional clarifications regarding the applicable legislation in order to assist medical device manufacturers and other parties involved in the interpretation thereof.
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