October 6, 2017
The Health Sciences Authority (HSA) drafted guidance, GN-34: Guidance Document for IVD Analyzers, to address the concerns of product owners and registrants with IVD analyzers and their associated accessories. GN-34 is “intended to act as a ‘one-stop’ document for IVD analyzers” which will cover the areas of risk classification, Singapore Medical Device Register (SMDR) listing options, family grouping criteria, product registration and change notification. HSA consultation is open for a one month consultation period, which ends on the 15th of October. Feedback and comments can sent via email to [email protected]
HSA’s updated approach focuses on the risk classification, product registration, devices listing and change notification. The updated approach on risk class will bring about some clarification on Rule 5 of GN-14. For the product registration of closed-system analyzers, there will be no change; hence, no additional product registration fees will be incurred.
For stand-alone analyzers, there will be a required product registration based on their intended use. For the device listing, companies can opt for the current listing approach where the analyzers are to be listed in the device listing of every compatible reagent kit, or they can opt for the analyzers to be listed separately from the reagent kits (also named “Split listing”), which will incur additional license retention fee.
Moreover, for the change notification of changes affecting the analyzers only, there will be no change if the company opts for the current listing approach wherein the change notification is submitted for all the affected device listings containing the analyzers, or if company opts for the proposed listing approach, the change notification will only need to be submitted for the affected analyzer device listing.
The following guidance documents will be affected by the revised approach for IVD analyzers, and HSA will be updating them and releasing them at the same time of the publication of the new IVD analyzer guidance:
- GN-12-1: Guidance on Grouping of Medical Devices for Product Registration – General Grouping Criteria
- GN-12-2: Guidance on Grouping of Medical Devices for Product Registration – Device Specific Grouping Criteria
- GN-14: Guidance on the Risk Classification of In-Vitro Diagnostic Medical Devices
- GN-15: Guidance on Medical Device Product Registration
- GN-21: Guidance on Change Notification for Registered Medical Devices
- GN-22: Guidance for Dealers on Class A Medical Devices Exempted from Product Registration
The tentative date of the proposed implementation after the consultation and finalization stage is on the 1st of December, 2017.
1) GN-34 Draft