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.
February 1, 2025
Approximately 5 minutes
India Medical Device Classification: Risk-Based System under Medical Devices Rules 2017
India Medical Device Classification System
The Central Drugs Standard Control Organization (CDSCO) in India employs a risk-based classification system for medical devices and In-Vitro Diagnostics (IVDs), as defined by the Medical Devices Rules, 2017 (MDR 2017). This classification is crucial as it determines the regulatory pathway, documentation requirements, and timeline for market authorization.
📈 Risk-Based Classification (Class A to D)
Medical devices are classified into four classes based on their intended use, level of risk, delivery method, and degree of invasiveness to the human body. The risk level ranges from low (Class A) to high (Class D).
| Classification | Risk Level | Authorization Requirement |
|---|---|---|
| Class A | Low | Online Registration/Self-Certification (Non-Measuring/Non-Sterile) or Import License (Measuring/Sterile) |
| Class B | Low-Moderate | Import License (MD-15) |
| Class C | Moderate-High | Import License (MD-15) |
| Class D | High | Import License (MD-15) |
As of October 1, 2023, all medical devices, including Class A (Measuring/Sterile), Class B, Class C, and Class D, are required to obtain an Import License before being imported and sold in India.
categorizing Products
The CDSCO classification process begins by grouping devices into 24 distinct product categories, which are more specific than standard global groupings. These categories include:
- Surgical Specialties: Cardiovascular, Neurological, Ophthalmic, etc.
- General Devices: General Hospital/Operation Theater (OT), Respiratory, Personal Use.
- IVD Devices: IVD products are categorized separately into IVD Analyzer, IVD Instrument, and IVD Software, and then further assigned a risk class (A-D).
The specific classification (A, B, C, or D) is determined within these categories based on the product’s detailed intended use and mechanism.
Regulatory Transition
The Indian regulatory system has been undergoing a mandatory transition, expanding the scope of devices that require registration and an Import License. This ensures all medical devices fall under the regulatory umbrella of the Drugs and Cosmetics Act of 1940. The CDSCO maintains a list of Notified Medical Devices that must comply immediately, but the mandate now covers virtually all device types.
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 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.