Changes Coming to Device Registrations in Singapore
Singapore’s Health Sciences Authority wants stakeholder feedback on updated proposals for submitting similar medical devices in a single product registration application.
Specifically, the authority is seeking input on GN-12-1: Guidance on Grouping of Medical Devices for Product Registration – General Grouping Criteria; and GN-12-2: Guidance on Grouping of Medical Devices for Product Registration – Device Specific Grouping Criteria.
The first document is intended to help companies determine whether certain devices may be included together and submitted in one application. It arranges products into the following categories: families, systems, IVD test kits, IVD clusters, groups and single.
To be considered part of the same device “family,” for example, products should meet the following criteria:
- They are from the same product owner;
- They are in the same risk classification;
- They have the same common intended purpose;
- They have the same design and manufacturing process; and
- Their variations are within a permissible scope, e.g., have a similar physical design, or have the same risk profile.
To help industry, the document provides a table listing permissible variants, as well as a flowchart to aid in determining whether a grouping of medical devices as a family is appropriate. It provides similar details for the other categories as well.
Stakeholders wanting the HSA to reconsider or review any aspect of this document may notify the authority by e-mailing with the subject line “Request for review of GN-12 grouping criteria.” The HSA will review all requests and update the documents as needed. Updates will occur once every six months.
The second document gives an overview of whether certain models of specific devices may be submitted in one product registration. It touches the following products: Class A and B dental medical devices, hearing aids, immunohistochemistry in vitro diagnostic reagents, fluorescence in situ hybridization probes in vitro diagnostic reagents and in vitro fertilization media.
The documents will go into effect Oct. 1.
The authority implemented the grouping system in 2008 to aid in registration of multiple models of similar medical devices that have the same intended purpose. “This eliminates unnecessary resource burden for both the industry in preparing and for the regulator in reviewing multiple submissions for similar devices with common technical validation,” an HSA spokesperson tells IDDM. “As a result, this enables timelier access of medical devices for patients’ clinical need.”
The move is part of an ongoing initiative by the HSA to streamline its processes for the filing of product registration. The authority holds sessions with stakeholders to gauge their opinion and solicit feedback. The next session is scheduled for September and attendees will offer their views on the revised documents how previous feedback affected the latest versions.