The article describes in detail the way the changes to medical devices are divided into categories and also highlights the key points to be considered in this respect.
The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to changes to medical devices already allowed for marketing and use in the country. The document describes in detail the responsibilities of registration holders concerning medical devices that are subject to modifications or changes. By the virtue of the guidance, the authority explains the way the regulatory status of such changes is to be determined, as well as the actions to be taken in this respect. At the same time, provisions of the guidance are non-binding in their legal nature, nor are intended to introduce new rules or impose new obligations, but rather to provide additional clarifications regarding the existing regulatory requirements, as well as recommendations to be followed to ensure compliance thereto. The authority also reserves the right to make changes to the guidance and recommendations provided therein, should it be reasonably necessary to reflect the amendments to the underlying legislation.
The document describes, inter alia, the way the changes to medical devices are divided into categories, and also outlines the main aspects related to each of the categories.
Change Categories: Overview
According to the guidance, the categories of changes to medical devices are:
- Technical Changes for Class C and D medical devices affect the safety, quality, or efficacy of these medical devices. For such changes to be implemented, prior approval of the authority is required.
- Review Changes for Class B medical devices affect the safety, quality, or efficacy of these devices and also require prior approval. The document further provides an exhaustive list of such changes, namely:
- Change(s) to indications for use of the registered medical device;
- Addition of new model(s) to a registered medical device listing;
- Removal and/or revision of warnings, precautions, contraindications, and/or adverse events;
- Modification of approved method of use.
- Administrative Changes are the ones related to the documents submitted in the course of the initial registration (such changes should be subject to prior approval), as well as the changes to the particulars published on the respective listing (such changes could be implemented immediately once the authority acknowledged the receipt of the appropriate notification).
- Notification Changes could be implemented immediately once the acknowledgment from the authority is received. According to the document, such changes are:
- Change to delete or remove device particulars that are published on public SMDR listing;
- All other changes which do not fall under Administrative, Technical, or Review changes, except for the changes that do not require a Change Notification to be submitted.
The authority also mentions that in case the changes are to be implemented in response to an adverse event (AE) that meets the reporting criteria, or in the course of Field Safety Corrective Actions (FSCAs), such changes could be implemented only after the fulfillment of all the reporting obligations under the respective regulations.
It is further stated that Notification Changes could be subject to bundling to be submitted to the authority as a single application. In certain cases, they can also be included in the scope of the Review/Technical change. The authority additionally emphasizes that the information regarding the changes to be included in the bundle should be communicated to the HSA within 6 months from the date the very first of these changes have been implemented. Furthermore, the parties responsible for medical devices allowed for marketing and use in the country should duly keep the records related to the changes they are making to the applicable QMS requirements. At the same time, bundled Notification Changes should not be applied concerning:
- Artificial Intelligence (AI) based devices (e.g., machine learning, neural networks, and natural language processing);
- Changes to the drug substance/medicinal product of combination product;
- AE/FSCA-related changes.
The authority explicitly states that the changes that were classified erroneously would not be reviewed, and will be rejected, together with the general prohibition of supply of the medical device in question. In such a case, the supply could be renewed only after the submission of a properly classified Change Notification.
To assist medical device manufacturers in following the approach described hereinabove, the HSA also provides a summary table outlining the aforementioned change types.
Changes to Class A Medical Devices
The scope of the guidance also describes the approach to be applied concerning changes to Class A medical devices, which are low-risk products under the existing medical devices classification rules. In particular, the authority addresses the matters related to Class A medical devices intended for use with a registrable medical device in a System and included in the appropriate entry in the register of healthcare products (SMDR). According to the guidance, a Change Notification submission would be required only if there are changes to the listing information of such Class A devices on the SMDR; these changes may be submitted together with other changes to registered medical devices of the System. The authority also mentions that as an alternative approach, the medical devices this rule applies to could be listed in the Class A Medical Device Database – a separate database for low-risk medical devices.
In summary, the present HSA guidance describes the approach to be applied for the categorization of changes to medical devices allowed for marketing and use in Singapore. The authority outlines the existing categories and highlights the key points to be taken into consideration when determining the category to be applied depending on the nature of the changes and the impact they are expected to have on the safety, quality, or efficacy of a medical device in question. As it is explained in the guidance, the regulatory burden and responsibilities of the registration holder would depend on the category of the changes determined as described herein.
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