The new article describes in detail the approach to be applied by a party responsible for a medical device when notifying the regulating authority about the changes to the product already placed on the market.
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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 medical devices. The document is intended to provide additional clarifications regarding the applicable regulatory requirements under which the parties responsible for medical devices allowed for marketing and use in the country are obliged to notify the authority in case of changes to the products. In particular, the document explains the way the applicable approach should be determined based on the nature of the changes, their significance, and potential risks associated thereto. The document also provides recommendations to be followed by medical device manufacturers and other parties involved in operations with medical devices. At the same time, provisions of the guidance are non-binding, and the authority reserves the right to make changes thereto, should it be reasonably necessary to reflect the respective amendments to the underlying legislation.
Application Process: Key Points
The scope of the guidance covers, inter alia, the aspects related to the application process for change notification. As explained by the HSA, once the party responsible for a medical device has identified the appropriate categories for the changes to be implemented, a Change Notification should be duly submitted to the authority.
The document further describes the key points to be considered when preparing and filing the application including, inter alia, the following ones:
- Should the changes fall within the scope of a single dossier, and single risk class, such changes could be submitted by the virtue of a single change notification;
- Should the changes be related to two or more dossiers, a single application could still be submitted, provided the appropriate requirements are met;
- A single application should be also submitted in case of identical changes related to the products of different classes (however, the scope of eligible changes is quite limited and outlined in the guidance).
The authority additionally emphasizes that it is not allowed to submit a Change Notification in case another one related to the same device is currently under review. In such a case, a party responsible for a medical device could either withdraw the initial Change Notification and submit a new one, or wait until the completion of the initial Change Notification process. It is also stated that in case of changes related to different categories, the highest (most strict) classification should be applied.
Change Notification Requirements
As further explained by the HSA, when commencing the Change Notification process, a party responsible for a medical device should submit:
- All supporting documents listed in Annex 1 as applicable for the change types;
- Duly completed Annex 2 to GN-21: Summary Table of Change Notification;
- Duly signed Annex 3 to GN-21: Medical Device Safety and Performance Declaration.
It is stated that the scope of documentation to be submitted should be determined based on all the changes the device is subject to.
According to the guidance, the whole Change Notification process comprises the following steps:
- Registrant identifies a change that requires Change Notification;
- Registrant submits Change Notification Application;
- Screening of the application;
- Depending on the nature of changes, the process includes evaluation for technical/review changes and verification of documentation for administrative change/notification pathways;
- Regulatory decision.
It is important to mention that once the Change Notification has been submitted via the appropriate electronic system, no changes thereto are admissible. The fees are payable per application, hence, an interested party should consider the applicability of grouping criteria.
As it was mentioned before, the applications falling within the scope of “Technical Change” and “Review Change” categories would be subject to evaluation by the HSA. In the course of the said evaluation, the authority would assess whether the changes in question are compliant with the applicable safety, quality, and performance requirements of the product. Based on this evaluation, the authority would determine the application as “approvable” or “non-approvable”. The later determination could also be made in case the applicant fails to provide the authority with additional information requested within the appropriate time frame.
Implementation and Supply
Under the general rule, a party responsible for a medical device may proceed with the actual implementation of changes once the appropriate approval has been granted by the HSA. It is also important to mention that the initial version of a medical device could still be supplied, provided it is fully compliant with the applicable regulatory requirements, including the Essential Requirements for Safety and Performance for medical devices as outlined in the respective Regulations. At the same time, a party responsible for a medical device should ensure that efficient measures are taken to make it possible to differentiate the initial and modified versions of a medical device. This applies to identification elements and traceability requirements which should be strictly followed, and the appropriate records should be duly maintained. Consequently, should the changes to a medical device be implemented in response to the safety- or performance-related issue(s), the initial device should no longer be available on the market. In case of any doubts, a party responsible for a medical device should request written advice from the authority in this respect.
Should the changes be related to the information about the product owner as indicated in the labeling, the authority expects to be notified about the transitional period reasonably necessary to replace the products with the ones containing the updated information. Moreover, the information about the changes to the product owner should be duly communicated to all the parties involved in operations with medical devices to ensure traceability and effectiveness of potential corrective actions. During the transitional period, the products containing outdated information provided in the labeling could still be supplied, however, they should be accompanied by the documentation indicating the new product owner. A similar approach should be applied concerning changes in manufacture and/or sterilization site. The authority mentions that the respective QMS certificate for an old facility should remain valid within the whole period when the products manufactured there are being supplied.
In summary, the present HSA guidance provides an overview of the Change Notification process and highlights key points to be taken into consideration to ensure compliance with the applicable regulatory requirements. The document outlines the scope of information to be submitted together with the application and also provides recommendations regarding specific cases.
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