Device types and eligibility Criteria
A memo has been published on the decision to fast-track the regulatory approval process for vaccines, diagnostics, prophylactics, and therapeutics for COVID-19. Notably, the CDSCO is creating a Coronavirus unit to address inquiries on the development of these products.
As noted, only Notified devices are subject to regulation by CDSCO; others can be imported and sold in India by simply complying with general customs requirements. The following list addresses the regulatory status of critical care devices under the current COVID-19 situation.
|
Device Type |
Regulatory Status |
|
Facemasks/respirators |
Registration not required |
|
Ventilators |
Registration not required |
|
Dialysis/infiltration machines and consumables* |
Registration not required |
|
Dialysis solution |
Registration required |
|
Endotracheal tubes |
Registration required |
|
Non-invasive ventilators (bipap) machines |
Registration not required |
|
Gowns, gloves |
Registration not required |
|
Oxygen masks (venturi masks) |
Registration not required |
|
**Central lines |
Registration not required |
|
**Arterial lines |
Registration not required |
|
Vascular catheters |
Registration required |
|
IVD test kits |
Registration required |
* Tubes used to connect the dialysis machine to the body are regulated.
** Tubes used to connect any instrument/device to the human body would be regulated.
Pathway overview
The CDSCO is prioritizing applications for COVID-19 test kits.
Any firm having an in-vitro diagnostic kit for COVID-19 can directly approach DCG(I) through public relations office to seek guidance for the regulatory pathway.
Any firm that has an IVD test kit already approved for COVID-19 in any other country can directly approach DCG(I) to discuss regarding expedited approval for marketing in India.
Prioritized applications are processed within 7 days. As part of the fast-track approval process, data requirements for performance evaluations may be abbreviated, deferred, or waived on a case-by-case basis, depending on type and nature of diagnostic kit, existing data on the product, and evidence of available clinical performance evaluation data of such kit.