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.
January 3, 2025
Approximately 5 minutes
India IVD Device Registration: Classification, Import License (MD-15), and Local Testing
India IVD Device Registration and Approval
The regulation of In-Vitro Diagnostic (IVD) medical devices in India is overseen by the Central Drugs Standard Control Organization (CDSCO) under the Medical Devices Rules, 2017. These rules establish a risk-based classification system for IVD devices, requiring most kits to obtain an Import License (MD Form 15) prior to importation.
⚙️ IVD Classification and Fees
IVD devices are classified into four risk classes (A, B, C, D). The classification determines the application complexity and associated processing fees.
| Classification Type | Plant Master File (PMF) Fee (USD) | Device Master File (DMF) Fee (USD) | Authorization Pathway |
|---|---|---|---|
| Class A IVD (Non-M/S) | N/A (Exempt) | N/A (Exempt) | Registration/Listing Only (No Cost) |
| Class A IVD (Sterile/Measuring) | $1,000 | $10 | MD-15 Import License |
| Class B IVD | $1,000 | $10 | MD-15 Import License |
| Class C IVD | $3,000 | $500 | MD-15 Import License |
| Class D IVD | $3,000 | $500 | MD-15 Import License |
The processing time for Import License applications (MD-15) is typically 6 to 9 months. Licenses are valid in perpetuity but require retention fees every five years.
📑 Technical Documentation Requirements
Registration for imported IVDs (Classes A Sterile/Measuring, B, C, D) requires the submission of a Device Master File (DMF) and a Plant Master File (PMF) to the CDSCO, along with key supporting documents:
- Proof of Reference Country Approval: Documentation of approval from a recognized reference country (e.g., USA, EU, UK, Japan).
- ISO 13485 Certification: Mandatory certification of the manufacturing facility's Quality Management System (QMS) is required as part of the PMF.
🧪 Mandatory Local Performance Evaluation
For high-risk IVD devices and test kits targeting specific life-threatening diseases, a mandatory Performance Evaluation Report is required from a local National Accreditation Board for Testing and Calibration Laboratories (NABL) accredited laboratory.
This requirement applies to kits related to diseases such as:
- HIV, Hepatitis B Virus (HBV).
- Blood Grouping Reagents.
- Tuberculosis, Malaria, Dengue, Chikungunya.
- Sexually Transmitted Agents and other life-threatening infections.
The performance evaluation must be submitted as part of the comprehensive registration application to the CDSCO.
Related Articles
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
Predicate Device Identification in India: Requirements for Equivalence and Clinical Data Waiver
Identifying a predicate device registered in India is key to the standard MD-14 Import License application. Devices without an Indian predicate may require local clinical data, often involving a Subject Expert Committee (SEC) review, unless they qualify for a waiver based on 2+ years of approval in a reference country.
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.