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:
- Proof of reference country approval
- ISO 13485 certification of the manufacturing facility
- Full technical details as per the prescribed requirements of the device master file.
Further, performance evaluation reports from the National Institute of Biologicals (NIB) are required for IVD devices and test kits related to:
- HIV
- HBV
- Blood Grouping Reagent
- Blood Glucose Test Reagent
- Cancer
- Tuberculosis
- Malaria
- Dengue
- Chikungunya
- Syphilis
- Typhoid
- Influenza
- ToRCH (Toxoplasma gondii, Rubella virus, Cytomegalovirus, Herpes simplex virus)
- Chlamydia
- Pneumonia
- Methicillin-Resistant Staphylococcus Aureus
- Entero Virus
- Marker for congenital disorder e.g. Screen test for Down Syndrome
- Sexually transmitted agent i.e. Treponema pallidum. Neisseria gonorrhoeae, Human Papilloma Virus, Herpes Virus
- Other life threatening infections/agents
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.
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