Medical Device and IVD Emergency Use Routes in India

In India, medical devices and IVDs are regulated by the Drug Controller General of India (DCGI) within the Central Drugs Standard Control Organization (CDSCO). The regulatory framework for medical devices and IVDs is based on drug regulations under the Drugs and Cosmetics Act, 1940 and Drugs and Cosmetics Rules, 1945 (D&C Rules), as well as on the Medical Device Rules, 2017 (MDR-17). Only certain ‘Notified’ devices are currently subject to registration by CDSCO. Note that all products meeting the definition of a medical device are legally subject to regulation; however, CDSCO is phasing in registration and so far, nothing has been phased in.

COVID-19 IVD test kits, hand sanitizer, surgical disinfectant, drugs, and vaccines have been put on a priority list for CDSCO and relevant approvals to be expedited. Frequent updates are made on the CDSCO website, which should be checked for current information.

Regulations, guidance, and resources

The following publications are relevant to the current special circumstances:

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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.

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