In vitro diagnostic (IVD) devices such as test kits and reagents are regulated as medical devices under the Medical Devices Rules, 2017. Importers need an import licence from CDSCO, applied for online with the manufacturer's details, free sale certificate, quality system certificates, device master file and performance evaluation data, based on the device's risk class.
Eligibility
An Indian importer with a wholesale licence, typically authorised by the foreign manufacturer.
Documents
- Power of attorney from manufacturer
- Free sale certificate from country of origin
- ISO 13485 or equivalent
- Device and plant master files
- Performance evaluation reports
Process
- Classify the IVD.
- Apply online with documents and fees.
- Respond to queries; evaluation may require testing.
- Receive import licence.
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Frequently asked questions
Is performance evaluation in India needed?
For certain IVDs, CDSCO may require evaluation by notified labs before approval.
Can one licence cover multiple products?
Products from the same manufacturer can be grouped per the rules, subject to classification.
How long does an IVD import licence take?
From several weeks to months depending on class and evaluation needs.
Do I need a test licence?
Test licences allow importing small quantities for testing and evaluation.
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