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April 1, 2025
Approximately 5 minutes
Predicate Device Identification in India: Requirements for Equivalence and Clinical Data Waiver
Predicate Device Identification in India
In India's medical device registration process, governed by the Medical Devices Rules, 2017, the existence of a registered predicate device significantly impacts the cost, time, and documentation required for a product to obtain an Import License (MD Form 15).
📜 Definition of a Predicate Device
The CDSCO defines a "predicate device" as:
“...a device, first time and first of its kind, approved for manufacture for sale or for import by the Central Licensing Authority and has the similar intended use, material of construction, and design characteristics as the device which is proposed for license in India.”
This definition emphasizes the need for substantial equivalence in intended use, materials, and design between the proposed device and the registered predicate.
Importance in Registration
- Standard Pathway: If a medical device has an identified predicate device registered in India, the manufacturer follows the standard Form MD-14 (Import License) application process.
- Clinical Data Requirement: If no registered predicate device can be identified, the device may be treated as "novel" or "first of its kind." This situation can trigger a requirement for pre-market or post-market clinical data from India, as determined on a case-by-case basis by the Subject Expert Committee (SEC) review.
🧪 Equivalence and Clinical Data Waiver
To establish a predicate device, the manufacturer must identify similar products that use similar technology and have the same indications for use. Simple differences, like a drug-eluting stent compared to an ordinary stent, would disqualify the latter as a predicate.
Exemption from Local Clinical Data
To alleviate the burden of requiring extensive clinical studies in India for devices entering the market, the CDSCO offers an important exemption:
- Devices that have been registered in a reference market for more than two years will be exempted from the local clinical data requirement.
- Reference Markets include the US, the EU, the United Kingdom, Japan, Canada, or Australia.
By demonstrating substantial foreign approval history, manufacturers can bypass the lengthy and costly local clinical investigation, even if an exact predicate is not yet registered in India.
🔍 Identifying the Predicate
Manufacturers should strategically identify potential predicate devices by:
- Identifying competing products that share the necessary characteristics (intended use, materials, design).
- Confirming that these potential predicates are officially registered in India via the CDSCO's public database or by working with local regulatory partners.
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