Local Regulatory Experts
Connect with regulatory affairs consultancies specializing in this region.
Registrar Corp
Hampton, Virginia (HQ), Shenzhen, China, London, United Kingdom, Paris, France, Madrid, Spain, Hyderabad, India, Kuala Lumpur, Malaysia, Tel Aviv, Israel, Guatemala City, Guatemala, Cape Town, South Africa
A global FDA compliance firm assisting businesses in the food, medical device, drug, and cosmetic industries with registration, U.S. Agent services, labeling, and regulatory software solutions.
ARQon Pte. Ltd.
Singapore (HQ), Malaysia, Vietnam, Indonesia, Philippines, Thailand, Taiwan, Hong Kong, South Korea, Switzerland, USA, Australia, New Zealand, Rwanda, India, Sri Lanka
We are a premier regulatory consultancy firm specializing in medical devices, in-vitro diagnostics (IVD), and pharmaceuticals. Founded in 2014, the company offers a comprehensive suite of services ranging from product development strategy and clinical trials to product registration and post-market surveillance. With a team of experts possessing vast experience in regulatory authorities and industry, we bridge the gap between scientific innovation and regulatory compliance, ensuring patient safety while fostering medical advancement. The company also provides unique business matching services through its ATTOPOLIS platform and training through the International Medical Device School.
Regulatory Compliance Associates Inc. (RCA)
Pleasant Prairie, WI, Tampa, FL
Regulatory Compliance Associates (RCA) is a leading global provider of regulatory and compliance expert consulting services for life science companies. The company offers expertise in regulatory affairs, assessments and audits, agency response, preparation and remediation, and new product development support for medical devices, pharmaceuticals, and compounding pharmacies.
Emergo by UL
USA, Canada, Brazil, Australia, China, Hong Kong, Taiwan, India
A dedicated partner for medical device and IVD manufacturers, we offers deep local regulatory expertise through its offices in over 20 global locations. Services include product registration, human factors research, clinical strategy, and local in-country representation to ensure rapid, compliant market access worldwide.
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.
Related Articles
Approximately 5 minutes
India IVD Device Registration: Classification, Import License (MD-15), and Local Testing
In-Vitro Diagnostic (IVD) devices in India are regulated by CDSCO under the MD Rules, 2017, and are classified by risk (A-D). Higher-risk IVDs (Classes B, C, D) require an MD-15 Import License based on submitted Plant and Device Master Files (PMF/DMF) and mandatory local performance evaluation for high-risk kits.
Approximately 5 minutes
India Medical Device Registration: Requirements for Import License (MD-15) under MD Rules 2017
India's CDSCO regulates medical devices under the Medical Device Rules, 2017. Imported Class B, C, and D devices require an MD-15 Import License, necessitating submission of a Device Master File (DMF) and Plant Master File (PMF) via a local License Holder.
Approximately 5 minutes
India Medical Device Classification: Risk-Based System under Medical Devices Rules 2017
India's CDSCO classifies medical devices based on risk (Class A to D), intended use, and invasiveness, adhering to the MDR 2017 Guidance. This system is crucial for determining registration requirements, with higher-risk classes (C and D) needing an Import License (MD-15) and a more rigorous review.
Approximately 5 minutes
India Medical Device Grouping: Maximizing Efficiency under MDR 2017 Guidance
India's CDSCO allows grouping of related medical devices (Family, System, Group, IVD Kits/Clusters) for registration under the MDR 2017 to simplify the application process, save costs, and reduce review time by submitting a common Device Master File (DMF).
Approximately 5 minutes
India Medical Device Local Labeling Requirements: Compliance Before Customs Clearance
Medical device labeling in India must comply with the Medical Devices Rules, 2017, and Legal Metrology Rules, 2013, with India-specific details (Importer contact, Registration Number, MRP) applied *before* Customs clearance. Electronic Instructions for Use (eIFUs) are accepted.
Approximately 5 minutes
India Medical Device Advertising Rules: Compliance with Approved Intended Use and UCMPMD
Medical device advertising in India must align strictly with the CDSCO-approved intended use (Form MD-15). Although a formal pre-approval process is lacking, compliance is enforced by the Drugs and Magic Remedies Act and the mandatory self-regulation under the Uniform Code for Marketing Practices in Medical Devices (UCMPMD).
Approximately 5 minutes
India's Central Drugs Standard Control Organisation (CDSCO): Regulator, Compliance, and Market Access
The CDSCO is India’s primary regulatory body, overseeing the import, manufacture, and sale of medical devices. Its main function is to ensure device safety, quality, and efficacy, which is achieved by issuing site-specific MD-15 Import Licenses based on the MD-14 application and facility inspections.