The article provides an overview of the changes to the applicable classification rules with respect to a specific category of medical devices.
Table of Contents
The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to the reclassification of medical devices that are substances to be introduced into the body or applied to and absorbed by the skin. The document describes the applicable transitional arrangements and obligations. The present guidance is intended to provide additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be taken into consideration by medical device manufacturers and other parties involved in order to ensure compliance thereto. At the same time, provisions of the guidance are non-binding in their nature, nor are intended to introduce new rules or impose new obligations. Furthermore, the parties involved in operations with medical devices are encouraged to request professional advice in order to ensure the correct interpretation of the applicable regulatory requirements. The authority also mentions that the present guidance could be subject to changes, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation.
Regulatory Background
In particular, the document describes the changes to the existing classification rules according to which from 25 November 2021, medical devices that are substances for introduction into the body will be required to meet regulatory requirements demonstrating the safety and performance for Class IIa (low-medium risk) or Class IIb (medium-high risk) devices. The new classification rules were initially discussed in 2019 when the authority initiated the appropriate public consultations. The main purpose of the said changes is to align the national regulatory requirements with the approach applied in the European Union. The authority also mentions that additional public consultation took place later in July 2021.
According to the guidance, the requirements for reclassification are:
- Conformity assessment documents demonstrating procedures appropriate for a Class IIa or Class IIb medical device;
- More detailed assessment of the manufacturer’s quality management systems and assessment of technical documentation related to each device.
Applicability Scope
The document further outlines the scope of healthcare products that the amended classification rules apply to. In particular, the changes impact the regulatory status of medical devices that are composed of substances or a combination thereof and are intended to be introduced into the human body. Depending on the effect caused and mode of action, this category includes, inter alia, such products as nasal sprays, dentifrices for sensitive teeth, products for topical use, wound protection gels, and creams.
When describing the products subject to the new classification requirements, the authority additionally emphasizes that the new rules could be applied only with respect to the products that meet the definition of a medical device as set forth under the current legislation. At the same time, the authority acknowledges that some of the products could also be subject to regulation as medicines (in this case, the term “borderline products” applies). It is also important to mention that sometimes the regulatory approach applied in various jurisdictions could be different – for instance, a product regulated as a medical device in other jurisdictions could be subject to regulation as a medicine in Australia since it will fall outside the scope of a medical device definition due to the different mode of action. The determination of the particular regulatory framework to be applied should be based on the principal mode of action and claims made by a product manufacturer and included in the documentation accompanying the product. The authority also states that the impact or effect the product may have or any other secondary intended purpose and dose administered should also be taken into account.
Apart from the above, it is also important to mention that a medical device that incorporates a substance that is a medical device itself, should be considered a Class III medical device for the purpose determination of the applicable regulatory requirements.
Key Factors to be Considered
In order to assist medical device manufacturers and other parties involved in applying the new classification rules described in the guidance, the authority also provides several examples of products falling within the scope of the new classification rules and also explains how the new requirements should be followed. In particular, when determining the regulatory nature of the product and applicable framework, a party responsible for the product in question should take into consideration the following aspects:
- The way the substance is intended to be introduced into the human body.
- If the substances are applied to the skin – whether they are intended to be absorbed by the body.
With respect to the latter, the authority additionally emphasizes that the products that are intended to be absorbed by the body present a higher risk by default since it is not always possible to cease or reverse the effect they cause in case they operate not as intended.
The factors outlined hereabove should be taken into consideration when determining the regulatory status of a new product, together with the level of invasiveness.
The guidance also provides several examples of the products subject to regulation under the amended classification rules and describes in detail the approach to be applied in this respect.
In summary, the present HSA guidance provides an overview of the changes to the country’s classification rules for some categories of medical devices, namely the ones that are substances intended to be introduced into the human body or to be absorbed by the latter. The document explains the regulatory approach the authority applies with respect to such products and highlights the key points to be taken into consideration in order to ensure compliance with the existing legislation.
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