The Health Sciences Authority (HSA), Singapore’s regulating authority in the sphere of medical devices and other healthcare products, has published a guidance document dedicated to IVD analyzers. Among other issues, the document provides additional clarifications regarding the listing of closed-system IVD analyzers in the SMDR, a country’s register of medical devices. In particular, the guidance addresses different situations and outlines the approach to be applied in each of them.
Listing of a New Closed-System Analyser
First of all, the guidance describes the procedure to be followed for listing a new closed-system analyzer. According to the guidance, there are two options available in such cases:
- IVD System Listing: listing of analyzers together with its compatible IVD reagents;
- SPLIT IVD Analyser Device Listing: listing of the IVD analyzers separately from the compatible IVD reagents. The IVD analyzer may be listed on its own, or with other IVD analyzers that meet the “Family” grouping criteria.
The authority also mentions that in the second case there would be additional expenses to be incurred by the applicant due to the registration retention fee. At the same time, the accessories intended to be used for analyzers could be included in the main application (for the analyzer itself).
The HSA additionally emphasizes that once a listing option from above has been selected, it would not be possible for the applicant to change it afterward.
Registration of a System With no Analysers Listed
The next case described in the document addresses the situations of product registration of closed IVD systems which do not have analyzers currently listed on SMDR in SPLIT IVD Analyser Device Listing(s). According to the guidance, the same regulatory requirements should be applied in terms of product registration. At the same time, the applicants should decide on a particular listing option to be used from the list provided here. Furthermore, should the applicant decide to follow the second pathway (SPLIT IVD Analyser Device Listing), two additional options would be available:
- A New IVD analyser listing; or
- An Existing IVD analyzer listing for which the Family grouping criteria are fulfilled.
It is stated that should the applicant decide to follow the second approach, a Change Notification would be required to amend the existing listing once the initial listing application is approved. Such a Change Notification should be marked as the one related to “Other Notification Changes” and supplemented by the appropriate documentation, namely:
- A copy of the approval letter fro the IVD System application under the MEDICS mandatory field “HSA e-mail”;
- List of compatible reagents with analyzers in SPLIT IVD analyzer device listings;
- Summary Table of Change Notification;
- Medical Device Safety and Performance Declaration;
- List of Configurations with the new analyzer model(s) highlighted.
The authority also mentions that it is necessary to indicate the reference number of the appropriate pre-market application.
To assist medical device manufacturers in following the procedures described hereinabove, the guidance also provides a flowchart to be used for determining the steps to be taken.
Registration of IVD Test Kits With Analysers Listed
The document also describes the requirements to be applied and the procedure to be followed in case of product registration of IVD test kits that have compatible closed-system IVD Analyser(s) already listed in the national register under SPLIT IVD Analyser Device Listing(s). In particular, the HSA states that in such cases it is allowed to remove the closed-system analyzer from the scope covered by the List of Configurations. Moreover, the general requirement to submit supporting documents usually required in the course of pre-market registration could be waived.
In such cases, the approach to be employed by the applicant should be the following:
- Should the new product subject to registration have no changes in comparison to a similar product already listed in the register, the applicant shall file the declaration for registered IVD analyzers in the SPLIT IVD analyzer device listing. Additionally, the applicant will have to file a Change Notification to amend the appropriate device listing.
- Should the new product differ from the one already included in the register, the applicant would have to file a declaration and a Change Notification as described above, and also to submit information about the changes.
As it was mentioned before, change notifications play important role in the regulatory procedures associated with the listing of IVD Analyzers. In this regard, the authority also refers to the appropriate guidance document dedicated to the matter: GN-21 Guidance on Change Notification for Registered Medical Devices.
The document further describes the particular procedures to be followed depending on whether there are any changes to the product in question, as well as on the nature of such changes and regulatory requirements associated thereto. For instance, the authority mentions that a special approach should be applied concerning changes to software used for IVD Analyzers. According to the guidance, all changes to the software of IVD analyzers will require a Change Notification application since software changes may impact the specifications of the IVD test kit or IVD analyzer, or both. The guidance also contains a detailed flowchart describing the process to be followed. The authority mentions that in some cases changes to the software could impact the characteristics of reagents as well. Hence, this should be also addressed in a Change Notification to be submitted by the entity responsible for a product.
The HSA encourages medical device manufacturers to review all the flowcharts provided in the guidance to determine the approach to be followed.
SPLIT Analyzer Listing Options
Apart from the aspects described hereabove, the guidance also addresses the matters related to the SPLIT Analyzer listing for registered IVD systems. It is stated that in such cases the submission of a Change Notification would be also required. The document further indicates the particular types of Change Notifications to be submitted and also outlines the scope of information and documentation to be provided by the applicant.
In summary, the present HSA guidance provides additional clarifications on applicable regulatory requirements for different options of applying for listing IVD Analyzers and products associated thereto in the national register of medical devices. The document pays special attention to the way the appropriate pathway should be determined and also provides additional recommendations to be taken into consideration by medical device manufacturers and other parties involved.
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