Import of Diagnostic Kit
I. Type of goods
Diagnostic Kit is a drug under section 3 of the Drugs and Cosmetics Act, 1940 and also a medical device under the Medical Device Rules, 2017.
II. Standardization/ Quality/Certification
i. BIS / ISO / IEC( International Electro Technical Commission), or by any other pharmacopoeial standards
ii. Conform to manufacturer’s standards
iii. ISO 13485 Certificate
III. Labelling requirement
Under the Drugs and Cosmetics Rules, 1945 and also the Legal Metrology (Packaged Commodities) Rules 2011
IV. Registration / NOC from CDSCO
Online Registration /NOC for Import of Testing Kit at the website of the Central Drugs Standard Control Organisation. https://cdscomdonline.gov.in/NewMedDev/Homepage
Testing Kit is not required registration under CHAPTER IIIA of Medical Rule 2017.
V. Testing of Diagnostic Kit ( COVID Kit)
i. Tests by the Drug Controller of India, after the National Institute of Virology validated its test
ii. The National Institute of Biologicals (NIB), NOIDA is designated as a Central Medical Device Testing Laboratory (CMDTL) by Government of India
I. Type of goods
Diagnostic Kit is a drug under section 3 of the Drugs and Cosmetics Act, 1940 and also a medical device under the Medical Device Rules, 2017.
II. Standardization/ Quality/Certification
i. BIS / ISO / IEC( International Electro Technical Commission), or by any other pharmacopoeial standards
ii. Conform to manufacturer’s standards
iii. ISO 13485 Certificate
III. Labelling requirement
Under the Drugs and Cosmetics Rules, 1945 and also the Legal Metrology (Packaged Commodities) Rules 2011
IV. Registration / NOC from CDSCO
Online Registration /NOC for Import of Testing Kit at the website of the Central Drugs Standard Control Organisation. https://cdscomdonline.gov.in/NewMedDev/Homepage
Testing Kit is not required registration under CHAPTER IIIA of Medical Rule 2017.
V. Testing of Diagnostic Kit ( COVID Kit)
i. Tests by the Drug Controller of India, after the National Institute of Virology validated its test
ii. The National Institute of Biologicals (NIB), NOIDA is designated as a Central Medical Device Testing Laboratory (CMDTL) by Government of India
