The article provides a brief overview of Singapore’s regulatory requirements in the sphere of change notification for medical devices.
The Health Services Authority (HSA), Singapore’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to change notification for registered medical devices. The document describes the approach to be applied by medical device manufacturers and other parties involved in operations with medical devices in case of changes thereto are implemented after the initial registration. In particular, the guidance provides additional clarifications regarding the existing regulatory requirements, as well as recommendations to be taken into consideration to ensure compliance thereto. At the same time, provisions of the guidance are non-binding, nor are intended to introduce new rules or impose new obligations. The authority also reserves the right to make changes to the recommendations provided, should it be reasonably necessary to reflect corresponding changes to the underlying regulations. It is also stated that in case of any doubts, the parties involved are encouraged to request case-specific professional advice.
The authority acknowledges that medical devices could be subject to changes and modifications after the initial registration. According to the applicable regulatory requirements set forth by the Health Products (Medical Devices) Regulations 2010, registration holders are obliged to notify the authority about the changes to medical devices they are responsible for, should such changes meet the notification criteria. Thus, by the virtue of this guidance, the authority intends to assist registration holders in determining whether a Change Notification is to be submitted. Recommendations provided in the guidance could be applied concerning any medical devices entered into the Singapore Medical Device Register (SMDR), a country’s register of medical devices approved for marketing and use.
According to the applicable medical device classification rules, all medical devices are divided into four classes (from A to D where A is the lowest and D is the highest) depending on the risks associated thereto when they are used for their intended purpose.
The HSA also mentions that these guidelines to Change Notification are based on the principles of safety, quality, and efficacy of medical devices supplied in Singapore; changes to a medical device can affect its safety, quality, or efficacy and must be approved before the modified device being supplied in Singapore unless otherwise indicated.
As it was mentioned before, the scope of the present HSA guidance covers any medical devices registered in the SMDR. In particular, the document highlights the key points to be taken into consideration by the registration holder concerning changes and modifications to a medical device it is responsible for. The authority explicitly states that the recommendations provided in the guidance are not exhaustive and do not cover all the situations that may take place, so in case of any clarifications needed, the registration holder is encouraged to get in touch with the Medical Devices Branch to discuss the changes it intends to implement. It is also stated that the scope of the guidance covers the cases when changes to a medical device are implemented in response to an adverse event associated thereto, or in the course of a Field Safety Corrective Action (FSCA).
Key Terms and Definitions
By virtue of the present guidance, the authority also provides definitions of the most important terms and concepts used in the context of changes to medical devices to assist medical device manufacturers and other parties involved in interpreting and following the applicable regulatory requirements. In this respect, the authority mentions that the definitions provided herein are expressed not in legal terms, but in a way understandable for laypersons. The definitions described in the guidance include, inter alia, the following ones:
- Accessory – an article that is intended especially 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.
- Control mechanism – a means for verifying or checking that the specifications or outputs of the medical device meet a standard or predetermined result;
- Label – about a health product or an active ingredient, means 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 any informational sheet or leaflet that accompanies the health product or active ingredient when it is being supplied;
- Intended purpose/intended use – the objective intended use or purpose, as reflected in the specifications, instruction, and information provided by the product owner of the medical device;
- Operating principle – how a medical device produces or brings about a desired or appropriate effect;
- Quality management system – certification to ISO 13485 or its equivalent;
- Indirect contact – the nature of body contact of medical devices, includes devices that contact the blood path at one point and serve as a conduit for entry into the vascular system.
Use of the Guidance
The HSA further explains the way the present guidance should be used to change registered medical devices. For instance, it is stated that in case several changes are to be made to a medical device at once, each of such changes should be assessed separately. Should it be identified that the change in question is subject to change notification to be submitted to the HSA, the party responsible for a medical device should provide detailed enough information about the differences between the initial medical device and the modified one. It is stated that the scope of documentation to be submitted to the authority for changes would be based on the nature of changes and specific aspects associated thereto. As it is mentioned by the HSA, the approach described in the guidance also applies to accessories.
It is important to point out that some of the changes are falling beyond the scope of Change Notification and, consequently, require a new application for marketing approval to be submitted. According to the guidance, such changes include, inter alia, the following ones:
- Change to the intended purpose;
- Change to the risk classification;
- Addition of model(s) that do not fulfill the grouping criteria, including permissible variants;
- Change to the medicinal substance in a device that incorporates a medicinal product in an ancillary role;
- Addition of medical devices with device proprietary names different from the registered devices, into a device listing.
As was mentioned before, the parties responsible for medical devices are encouraged to contact the authority and ask for additional clarification in the case of any doubts about the regulatory status of the changes to be implemented.
In summary, the present HSA guidance describes the regulatory approach to be applied in case of changes to medical devices already allowed for marketing and use in Singapore. The document highlights the key points to be considered when determining whether a Change Notification will suffice, or a new application for registration will be required.
How Can RegDesk Help?
RegDesk is a next-generation web-based software for medical device and IVD companies. Our cutting-edge platform uses machine learning to provide regulatory intelligence, application preparation, submission, and approvals management globally. Our clients also have access to our network of over 4000 compliance experts worldwide to obtain verification on critical questions. Applications that normally take 6 months to prepare can now be prepared within 6 days using RegDesk Dash(TM). Global expansion has never been this simple.
Want to know more about our solutions? Speak to a RegDesk Expert today!