Effective 1st July 2024, a new registration initiative – NextGen MD, is available for product owners who are keen to market their next-generation MDs/IVDs in Singapore. The registration requirements follow the latest GN-15: Guidance on Medical Device Product Registration, with an additional task of completing the NextGen MD form. This form consists of two parts, namely:
- Part 1: Comparison Table of Next Generation Device versus Registered Device;
- Part 2: Justification on Relevance of Previously Submitted Data to the Next Generation Device.
Please note that this initiative is only applicable to the Full Evaluation Route.
Qualification criteria of NextGen MDs/IVDs as extracted from the source is as shown below:
| General Medical Devices | In-Vitro Diagnostic Medical Devices |
|---|---|
| All models in the application must meet ALL of the following criteria when compared with the registered device: | All reagents in the application must share ALL of the following criteria when compared with the registered device: |
| a) Same product type | a) Identical formulation AND labelled storage condition |
| b) Identical validation for Biocompatibility, Sterilization, AND Shelf-life | b) Identical intended use and indications for use |
| c) Identical sample type |
The registered device must meet the following:
- Same Product Owner and Registrant as the next generation device.
- Registered with HSA via ABRIDGED or FULL route.
- If you are leveraging the changes made to the registered device, the changes must be registered via a REVIEW or TECHNICAL CN.
- Registered on SMDR (i.e. active listing) at point of submission of the next generation device.
This initiative aims to enable product owners to capitalize on relevant technical documents already submitted for the registered devices, thereby reducing the bulk of the workload (since product owners will not have to re-perform all validation and verification tests on their NextGen devices).
Further information can be accessed here nextgen-md-initiative.pdf (hsa.gov.sg).
If you have any queries about this draft guidance, please contact us at sales@andamanmed.com or click the button below.