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.
March 1, 2025
Approximately 5 minutes
India Medical Device Grouping: Maximizing Efficiency under MDR 2017 Guidance
India Medical Device Grouping for Registration
The Indian regulatory system, governed by the Medical Devices Rules (MDR) 2017, provides specific guidance on the grouping of medical devices and IVDs. Grouping allows manufacturers to include multiple related products or configurations under a single application and potentially a single fee, leading to a more cost-effective and time-saving registration process.
🗂️ Grouping Categories and Requirements
Grouping requires that the products share key attributes, such as common risk classification, intended use, and manufacturing process.
1. Device Family
A Family consists of products that share a common risk classification, license holder, intended use, design, and manufacturing process. They can be registered under a single fee and a common Device Master File (DMF).
- Permissible Variants: Products within a Family may have slight differences (variants) in features without affecting their core characteristics.
- Example Variants: Catheters with different numbers of lumens or coating materials; Stents with different delivery systems (over the wire vs. through the scope); Orthopedic Implants with cemented or non-cemented fixation.
2. System
A System includes a medical device and its accessories that work in combination to achieve a common intended purpose, sold under the same proprietary name and license holder.
- Packaging: If sold and imported as a single unit package, it can be registered under a single application and fee, though separate documentation for individual components is required. If the manufacturer intends to sell components separately, separate fees and documentation apply for each component.
3. Group
A Group consists of two or more medical devices that are imported and sold in the same packaging under a common proprietary system name and intended purpose.
- Key Feature: Allows for different manufacturers within the Group, provided they share a common license holder.
- Fees: A single fee applies for the Group, but separate documentation must be provided for each medical device within the Group.
4. IVD Test Kit and Cluster
- IVD Test Kit: Contains reagents and/or articles intended to be used in combination for a common intended purpose (excluding analyzers). If sold as a single unit package, a single fee and application can apply, with separate documentation for components.
- IVD Cluster: Contains IVD reagents/articles with a common license holder and methodology but may have different intended uses. Separate fees apply for each product, but a common DMF can be submitted.
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
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.