The first article provides a brief overview of the general rules for grouping medical devices when applying for marketing approval in Singapore.
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The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to the grouping of medical for product registration. The scope of the guidance covers general grouping criteria to be considered by medical device manufacturers intended to place their products on the market. The document is non-binding and is intended to provide recommendations to be followed by the parties involved to ensure compliance with the applicable regulatory requirements, while in case of any discrepancies with provisions of respective legislation the latter should prevail. The authority also reserves the right to amend the document and recommendations provided therein, should it be necessary to reflect the changes and amendments to the underlying legislation. The scope of the guidance covers any medical devices that are subject to regulation by the HSA, so the requirements described therein should be followed when applying for marketing approval for all such products.
The authority also mentions that an interesting party may submit a request to reconsider the grouping criteria. Such a request should be duly justified and contain the following details:
- Device type and description;
- Existing grouping options and their limitations (if any);
- Proposed grouping criteria and the rationale;
- Technical/scientific information to support the above proposal.
The authority will review the requests submitted as described hereinabove and make changes to the respective guidance documents. The HSA additionally emphasizes that any changes would become applicable only after being published as updates to existing guidelines.
Regulatory Background
As explained by the HSA, the guidance is intended to assist medical device manufacturers in determining whether the products in question could be submitted for registration under the single application. The guidance is based on the Health Products Act which prescribes that any medical devices intended to be marketed and used in the country are subject to prior registration with the HSA unless they are falling within the scope of special exceptions.
Under the general rule, medical devices could be supplied either as separate products or as part of kits or packs. Moreover, they could be also made available to customers in different configurations. It is important to mention that the scope of the present guidance covers general grouping criteria, while device-specific grouping criteria are addressed in separate guidance published by the HSA. The parties interested in placing their products on the market should familiarize themselves with both documents and follow recommendations provided thereto when applying for marketing approval.
Terms and Definitions
To assist medical device manufacturers in interpreting the applicable regulatory requirements, the document provides definitions of the most important terms and concepts used in the context of medical device grouping, including the ones that are not initially provided in the underlying legislation. The authority explicitly states that the definitions provided herein should not be construed as legal definitions but as additional clarifications. The definitions the authority provides include, inter alia, the following ones:
- Accessory – an article that is intended specifically by its product owner to be used together with a particular medical device to enable or assist that device to be used for its intended purpose. The authority also mentions that accessories are usually intended to be used for purposes falling within the scope of the medical device definition, hence, are subject to regulation under the medical device framework.
- Proprietary name – a unique name given by the product owner to identify a medical device as a whole product, also known as the trade name or brand name.
- Intended purpose / intended use – the objective intended use or purpose, as reflected in the specifications, instructions, and information provided by the product owner of the medical device. It is important to mention that this definition is provided in the applicable regulation.
- Product owner stands for an entity that places a medical device on the market under its name, and is responsible for operations with this device, including device development, manufacturing, etc., even in a case such activities are outsourced to other entities.
Grouping: General Principles
The guidance further provides clarifications regarding the general principles of grouping to be applied for medical devices when applying for product registration. However, the authority also mentions that the way medical devices could be listed in the country’s register of medical devices – the Singapore Medical Device Register (SMDR) – could be different from the way they were submitted for registration. The authority provides an example of the situation when medical devices with different proprietary names are submitted for registration under the scope of a single application since they meet the applicable grouping criteria. In such a case, they will anyway be registered separately.
It is also stated that medical devices submitted for registration could contain other medical devices or accessories thereto, produced by other manufacturers. In such a case, an entity applying for registration of the final product should be responsible for the overall performance and safety.
The document also clarifies the way the details about manufacturers should be indicated in the register. For instance, in case the device submitted for registration could be used with instruments or accessories from other manufacturers, only the initial device manufacturer would be mentioned in the respective entry, even though it would be necessary to provide information about compatible accessories in the course of the registration process. The authority additionally emphasizes that only medical devices that are duly registered and included in the SMDR are allowed for marketing and use in the country.
Once the device is registered, the registrant shall be responsible for ensuring compliance with any requirements related to post-market activities. In particular, it should:
- Comply with the conditions applicable to the registered medical device and conditions imposed on the registrant;
- Submit applications to the authority for changes made to the registered medical device;
- Maintain records of supply;
- Maintain records of complaints;
- Report defects and adverse effects to the authority; and
- Notify the authority concerning field safety corrective action (FSCA), including recall.
In summary, the present HSA guidance provides an overview of the general grouping principles and also highlights certain specific aspects to be considered by the parties interested in placing their products on the market. The document also provides definitions of the most important terms and concepts used in the context of medical device grouping and describes the way they should be interpreted.
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