Contact Us
US: +1 512 898-9222
SG: +65 3138-4148
EMAIL: India@asiaactual.com
IVD product registration in India is overseen by the Central Drugs Standard Control Organization (CDSCO). The new Medical Device Rules, 2017 significantly expands the number of IVD devices requiring full technical documentation in support of their registration applications. Formerly only the critical IVD devices required registration with complete device master file, prior to being placed on the market in India. Under the new Rules, a risk-based classification is provided for IVD devices and all test kits must obtain Form MD 15 prior to importation.
Required elements of the registration application include:
Further, performance evaluation reports from the National Institute of Biologicals (NIB) are required for IVD devices and test kits related to:
Performance evaluation reports must be conducted by a local National Accreditation Board for Testing and Calibration Laboratories (NABL) accredited laboratory.
The CDSCO processing fees vary by risk classification as per the table below. Processing times are expected to take 6 to 9 months. Successful applicants will be issued an Import License (aka MD Form 15) which is valid for perpetuity, with retention fees due every five years.
Classification Type | Plant Master File | Device Master File |
---|---|---|
Class A IVD | US$1,000 | US$ 10 |
Class B IVD | US$ 1,000 | US$10 |
Class C IVD | US$ 3,000 | US$ 500 |
Class D IVD | US$ 3,000 | US$ 500 |
Asia Actual can manage and submit Import License applications and local performance testing to ensure the efficient, timely and secure issuance of certificates. Contact Asia Actual about registering IVD devices in India.
US: +1 512 898-9222
SG: +65 3138-4148
EMAIL: India@asiaactual.com
実際の亞洲
เอเชีย แอคชวล
एशिया वास्तविक
실제 아시아
515 Congress Avenue, Suite 2100
Austin, TX 78701
+1 512 898-9222
Contact Us
Privacy Policy
116 Changi Road, #04-05