The Health Sciences Authority (HSA), Singapore’s regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the registration of medical devices. Apart from the general requirements for registration of medical devices depending on their classes under the applicable risk-based classification, the document highlights other important aspects to be considered by the medical device manufacturers and other parties interested in placing their products on the country’s market.
In particular, the scope of the guidance covers the regulatory matters related to:
- Priority review scheme;
- Medical devices incorporating medicinal product;
- Turn-around-time (TAT) for product registration;
- Product registration fees;
- Changes to a registered medical device;
- Amendment of device listing;
- Annual retention fee; and
- Cancellation of registration.
However, it is also important to mention that while the document describes the approach suggested by the HSA as a national regulating authority, it should not be used as a basis for any regulatory decisions taken without obtaining additional legal advice.
Priority Review Scheme
According to the present HSA guidance, the Priority Review Scheme is intended to facilitate the process of placing new medical devices on the market and allows interested parties to achieve a significant reduction of time necessary to complete all regulatory procedures in comparison to the general pathway – the Full evaluation route. There are two routes available depending on the medical device in question.
- Route 1 applies for medical devices intended to cure specific diseases, provided they are also intended for an unmet clinical need which is defined as:
- Intended for a medical purpose with no existing alternative treatment or means of diagnosis; or
- Represents a breakthrough technology that provides a clinically meaningful advantage over existing legally marketed technology.
- Route 2 should be applied for medical devices falling outside the scope of eligibility criteria described hereabove.
Medical Devices Incorporating Medicinal Product
Specific rules should also be applied in the case of medical devices incorporating medicinal products, in case such a product has an ancillary role in the context of the intended use of a medical device. Hence, both regulations for medicines and medical devices would be applicable.
The main concept to be considered in this regard is the concept of the “Primary mode of action (PMOA),” which stands for the mode of action that makes the greatest contribution to the overall intended therapeutic purpose of the combined product. According to the applicable legislation, the medical devices’ framework covers the products that are not intended to achieve their primary mode of action by pharmacological, immunological, or metabolic means. Otherwise, such a device would be subject to regulation as a medicine. The document also provides some examples of medical devices containing medicines. In accordance with existing risk-based classification, such medical devices are to be assigned to Class D.
Moreover, due to their specific legal nature, the assessment should be carried out not only by the Medical Devices Branch but also by the Therapeutic Products Branch of the authority. The HSA also states that if such a medical device has been approved for marketing and use by one of the recognized foreign regulating authorities, it would be eligible for the abridged evaluation route. If the device is intended to be placed on the market for the first time, it should be subject to full evaluation. The authority additionally mentions that in case the medicine the device contains is exempted from registration under the applicable medicines framework, the class of the product, in general, should be determined depending on the class of a medical device. In case of any doubts with regard to the proper classification of the product, the interested party may ask the regulating authority for determination.
Turn-Around-Time (TAT) for Product Registration
According to the guidance, the regulating authority takes all the steps necessary to ensure the applications for marketing authorization are reviewed in a timely manner. At the same time, the interested entity applying for such authorization should ensure the application submitted to the HSA is complete and contains all the necessary documentation and information necessary for the authority to assess the product in question and all safety- and performance-related matters associated thereto. Should the application be incomplete, the authority would request additional information to be provided, which will result in delays for the process in general.
As stated in the document, the target turn-around-time (TAT) for product registration applications commences from the date of receipt of the application does not include “stop-clock time” due to input requests for clarifications and additional information. The authority additionally mentions that if field safety and corrective actions are taken with regard to the medical device in question, the review process would be temporarily suspended until the issues are resolved.
The guidance also provides review timelines that depend on the applicable pathway (e.g., Immediate, Expedited, Abridged, Full, Priority Review Scheme) and also on the class of the medical device subject to review.
Changes to a Registered Medical Device
The document also describes the applicable regulatory requirements in the sphere of changes to medical devices already placed on the market and change notification rules. In particular, it is stated that the entity responsible for a medical device should file the appropriate notification in case of changes that could potentially affect the safety, quality, or efficacy of a medical device that has been already approved for marketing and use in Singapore. The HSA also refers to the guidance dedicated to the matter issued earlier by the authority.
If the changes to the registration constitute only a typographical error, the appropriate request should be submitted to the regulating authority to agree on further steps.
Annual Retention Fee
According to the applicable legislation, the parties responsible for medical devices should duly pay the annual retention fee for maintaining the validity of medical device registration. Should the interested party fail to make payment in time, this could result in the cancellation of registration. In case of delays exceeding one month, the entity responsible for a medical device should provide the appropriate justifications. Should the delay exceed two months, the registration could be canceled.
Cancellation of Registration
In certain cases, the regulating authority is entitled to cancel the registration of a medical device. In such a case, the entity responsible for the medical device would receive the appropriate written notice and would also have a right to be heard. Upon cancellation of the registration, any and all parties involved in supplying such a medical device would be obliged to cease such activity.
In summary, the present HSA guidance highlights additional aspects to be considered with regard to the registration of medical devices in Singapore. The document outlines the applicable regulatory requirements and provides clarifications regarding the key points.
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