The new article highlights the key points related to the application process to be followed when notifying the authority about the changes to registered medical devices.
The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to the changes to registered medical devices and regulatory procedures associated thereto. The document describes in detail the approach to be applied concerning different types of changes depending on their regulatory status. It is important to mention that 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 considered 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 corresponding changes to the underlying regulations.
Application Process: Key Points
The scope of the guidance covers, inter alia, the aspects related to the application process to be followed in terms of change notifications. It is important to mention that before submitting an application, the party responsible for a medical device in question should determine the legal nature of the changes and the particular pathway to be followed following the respective flowcharts.
The authority also explains that in certain cases, changes could be combined into groups and submitted as a single Change Notification application. In this respect, the authority outlines the following rules:
- If the changes are of the same risk class and related to the same registration dossier, several changes could be combined in one application and submitted together. In such a case, the fees payable and the review flow to be applied would be determined based on the highest applicable change category.
- If the changes are of the same risk class but are related to different dossiers, a single Change Notification application could be submitted for identical administrative and notification changes to multiple SMDR listings or where the same new product is added to multiple SMDR listings if the changes are submitted together (SMDR states for the Singapore Medical Device Register, a country’s register of medical devices allowed for marketing and use in the country). The authority additionally emphasizes that in case the notification submitted will cover the changes that are not identical, such notification will be rejected.
- In certain cases, a change notification could cover identical changes related to SMDR listings of different risk classes, provided such changes are within the scope outlined below:
- Change in product owner;
- Change in the manufacture and/or sterilization site;
- Change only involves an update of the QMS certificate validity date;
- Addition of identical Class A accessories.
- It further stated that in case of identical changes related to the current Field Safety Corrective Actions (FSCAs) or Adverse Events (AEs) subject to reporting, related to the registered products of different classes under the applicable risk-based classification, additional advice from the authority should be obtained.
The authority also mentions that in case there is a pending Change Notification application to a medical device, the new one cannot be submitted. In such a case, the registration holder can either:
- Withdraw the pending Change Notification application and submit a new change notification application, or
- Submit a new Change Notification application once the pending Change Notification application is completed.
Under the general rule, in case of an application covering the changes of several types, the classification should be based on the most stringent category. This applies to the review flow, Turn-Around-Time (TAT), and also the fees the applicant will have to pay.
Requirements for Change Notification
The guidance also outlines the list of documents an interested party has to submit. According to the document they include the following ones:
- All supporting documents required for a specific change type,
- Summary Table of Change Notification,
- Medical Device Safety and Performance Declaration.
The authority additionally emphasizes that when determining the scope of documents to be submitted, a registration holder should take into consideration all the changes covered by the scope of a Change Notification application.
The document also contains a flowchart illustrating the whole process for Change Notifications related to Class B, C, and D medical devices. According to the flowchart, the said process includes the following steps:
- The registrant identifies a change that requires a Change Notification,
- Registrant submits Change Notification application,
- Screening of application,
- Evaluation of application (technical/review change), verification of documentation (administrative change/notification),
- Evaluation decision (technical/review change),
- Regulatory Decision.
The HSA additionally emphasizes that once an application related to changes has been submitted via the respective online system, no further changes thereto would be accepted. As it was mentioned before, an application fee should be paid per application, hence, medical device manufacturers may combine several changes under a single application, provided the grouping criteria described herein above are met.
According to the guidance, Change Notification applications submitted under the “Technical Change” or “Review Change” pathways would be subject to evaluation to be carried out by the authority. The latter will conduct a rigorous assessment of the information submitted by the applicant and make its decision based on the results of such a review. In particular, the authority will determine whether the Change Notification application is approvable (if the changes made to the device are compliant with all applicable regulatory requirements in terms of safety and effectiveness) or non-approvable (in case the changes to the device are non-compliant, or the applicant fails to provide the proper response in time).
In summary, the present HSA guidance describes in detail the review process for Change Notification applications and highlights the key points to be considered. The document provides an overview of the applicable grouping requirements and provides a flowchart illustrating the review process.
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