Import of Diagnostic Kit - Medical device and Drug -Registration, Certification,Testing, labeling and NOC

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