In October 2008, Singapore’s Health Sciences Authority (HSA) released a draft guidance document for In Vitro Diagnostic (IVD) medical device product registration applications. The HSA implemented the new Common Submission Dossier Template (CSDT) for medical device registration in late 2008 as part of moving towards a more stringent medical device regulatory system. The new guidance document clarifies how the CSDT requirements specifically apply to IVDs when filling out a product registration application.
In general, the CSDT must be prepared in English. Copies of labels, certificates, and reports that are referenced within the CSDT submission must be submitted in their entirety as appendices. Products that have marketing approval from Australia, Canada, the EU, Japan, or the U.S. usually qualify for an abridged evaluation route, whereas all other products must complete submission in full.
For IVDs specifically, in the device description, there should be a description of all components of the IVD (including antibodies, antigens, buffers, substrates, and reagents), specimen collection and transport materials, accessories, and other medical devices (IVD or non-IVD) to be used in combination with the product being registered. There should also be a general description of the principle of assay method or instrument principles of operation. If the IVD device is to be registered as a family or group, then descriptions or a list of the various configurations should be submitted as well.
Information on the device’s intended use needs to be submitted as well, which includes the following: the type of substance measured or analyzed; whether the test is quantitative or qualitative; the role of the test in clinical use; the disease that the test is intended for; the intended users; assay type; type of specimen to be used; and specific name of the instrumentation required for the assay. For instruments, the intended use should also include the instrument modes of operation.
For verification of the device, data should be submitted showing the suitability of the IVD for each of the intended specimen types (e.g., serum or plasma) through pre-clinical and clinical studies.
A risk management report must be filed, with details on the risks and benefits associated with the use of the IVD. The HSA recommends that risk management activities be conducted according to ISO 14971.
Other specific clarifications include details for pre-clinical and clinical data, manufacturing, and device labeling.