Gunjan Verma - India

“The new guidance applies to real time RTPCR, RAT, home based testing solutions, antigen/antibody ELISA/CLIA, and rapid antibody tests.”

Gunjan Verma
Managing Partner
Asia Actual India

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India Exempts COVID Test Kits Approved in Reference Countries from Validation Testing

Published on: May 18th, 2021

COVID Test Kits Approved in the USA, EU, Korea, Japan, Australia, Brazil, or by WHO Are Now Exempt

As of April 27th, India’s CDSCO will allow COVID test kits with the following reference country approvals to bypass in-country validation testing. Previously only tests kits approved by the USFDA (including Emergency Use Authorization) were exempt.

COVID test kits approved by the following agencies are now exempt from in-country validation testing:

  1. United States Food and Drug Administration (USFDA)
  2. European CE/IVD
  3. Ministry of Food and Drug Safety of Korea (formerly known as Korea Food & Drug Administration or KFDA)
  4. Pharmaceuticals and Medical Devices Agency (PMDA) of Japan
  5. Therapeutic Goods Administration (TGA) of Australia
  6. Brazil’s ANVISA
  7. WHO’s Emergency Use Listing (EUL)

COVID Test Kits Applicable Products

The new guidance applies to real time RTPCR, RAT, home based testing solutions, antigen/antibody ELISA/CLIA, and rapid antibody tests. It is also applicable for tests using nasopharyngeal, oropharyngeal, throat, nasal, oral, saliva, mouth rinse, gargle, blood, and serum samples.

Regulatory Requirements in Addition to Validation

Once a COVID test kits has approved by the ICMR (or exempt via reference country approval), manufacturers will need to submit a full Device Master File (DMF). Regarding Plant Master Files (PMF) for new manufacturers, the CDSCO is currently accepting ISO 13485 certificates in lieu of typically required documentation. COVID test kits have also been up classified to Class C.

All manufacturers with point of care testing software will also need to meet with an ICMR team to ensure compatibility with the ICMR COVID-19 testing portal.

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Asia Actual assists medical device manufacturers navigate the regulatory requirements in Asia and build comprehensive regulatory and sales strategies for growing sales in the region.

Contact Asia Actual for more information or to discuss the region’s potential for your medical device or IVD.

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