The article provides an overview of the regulatory requirements related to change notification for medical devices that are already placed on the market.
The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to the change notification requirements for registered medical devices. The document is intended to provide additional clarifications regarding the interpretation of the applicable regulatory requirements, and also recommendations to be followed by the parties involved. At the same time, provisions of the guidance are non-binding, so in case of any discrepancies with provisions of the underlying legislation, the latter should prevail. The authority also reserves the right to make changes to the guidance from time to time, should it be reasonably necessary to reflect the respective changes to the regulatory framework. It is also stated that in case of any doubts, professional advice should be obtained before taking action.
The authority acknowledges that medical devices could be subject to changes during their life cycle. By the virtue of the present guidance, the HSA intends to describe the approach to be followed by the parties responsible for medical devices concerning the changes implemented after the product has been approved for marketing and use and made available to customers. The Health Products (Medical Devices) Regulations 2010 prescribe that the registration holders are obliged to submit change notifications to the authority concerning the products registered in the Singapore Medical Device Register (SMDR), a country’s register of healthcare products.
The authority also reminds us that under the general rule, all medical devices could be divided into 4 classes depending on the risks associated thereto. The applicable classification system is described in detail in the respective guidance document issued by the HSA. According to the document, these guidelines to change notification are based on the principles of safety, quality, and efficacy of medical devices supplied in Singapore; while 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.
The scope of the present guidance covers any medical devices subject to registration in the national register of healthcare products. In particular, the document outlines the key points to be considered by medical device manufacturers and other parties involved in operations with medical devices when determining the regulatory status of changes and deciding on steps to be taken to comply with the change notification requirements. At the same time, the authority additionally emphasizes that the scope of the guidance and recommendations provided therein does not cover all the situations that may occur. Hence, the particular approach to be followed should be determined on a case-by-case basis depending on the nature of the device in question, its characteristics, and features, and also the risks associated thereto. Moreover, the registration holders are also encouraged to contact the authority to obtain additional clarification.
The authority also states that the scope of the guidance covers all the types of changes medical devices could be subject to including, inter alia, the changes to labeling resulting from an Adverse Event (AE) that meets reporting criteria, or an ongoing Field Safety Corrective Action (FSCA).
Terms and Definitions
First of all, the document provides the definitions of the most important terms and concepts used in the context of change notification requirements including, inter alia, the following ones:
- Control Mechanism – an approach to be applied for verifying or checking that the specifications or outputs of the medical device meet a standard or predetermined result;
- Label – 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 information sheet or leaflet that accompanies the health product or active ingredient when it is being supplied;
- Operating principle – the one by which a medical device produces or brings about a desired or appropriate effect.
The authority further describes the approach to be applied by the registration holder when assessing the changes and determining their regulatory status. For instance, according to the guidance, in the case of several changes taking place simultaneously, the registration holder should assess each of such changes separately. Should it be determined that the change in question meets the appropriate change notification criteria, the registration holder should duly submit such notification within the timeframes and by the procedures set forth by the applicable legislation. The said notification should be accompanied by a detailed description of changes and differences in comparison to the initial device.
The authority also mentions that certain changes require not the change notification, but an entirely new submission. The examples of such changes include the following ones:
- Change to the intended purpose of a registered medical device;
- Change to the risk classification of a registered medical device;
- Addition of model(s) that do not fulfill the grouping criteria, including permissible variants, as listed in the GN-12 guidance documents on Grouping of Medical Devices for Product Registration;
- 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.
Categories of Changes
According to the guidance, all changes to medical devices registered in Singapore could be divided into the four categories as follows:
- Technical Changes to high-risk (Class C and D) medical devices that impact quality, safety, or effectiveness; and, consequently, subject to HSA’s prior approval.
- Review Changes to Class B medical devices as per the respective exhaustive list. Such changes are subject to prior approval as well. These changes include, inter alia, changes to indications for use, removal and/or revision of warnings, or modifications of the approved method of use.
- Administrative Changes include changes to the documents submitted at the stage of the initial registration of a medical device before being placed on the market. The changes of this type could be implemented immediately once the authority confirms the receipt of the appropriate notification.
- Notification Changes include all other changes that fall outside of the above mentioned categories. Such changes could be implemented immediately once the authority confirmed the safe receipt of the respective notification via the electronic submission system.
The authority additionally emphasizes that if the change is in the context of, or is a consequence of a reportable Adverse Events (AEs) or Field Safety Corrective Actions (FSCAs), implementation of such changes can only proceed after the FSCA/local AE cases have been reported to the Medical Devices Branch (MDB).
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