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.
December 1, 2024
Approximately 5 minutes
India Medical Device Registration: Requirements for Import License (MD-15) under MD Rules 2017
India Medical Device Registration: Import License (MD-15)
Medical device regulation in India is governed by the Central Drugs Standard Control Organization (CDSCO) under the Medical Devices Rules, 2017. Since October 1, 2023, all medical devices (except certain Class A non-measuring/non-sterile) must be registered and require an Import License (MD Form 15) for market access. Foreign manufacturers must appoint a local entity to act as the License Holder.
⚙️ Classification and Market Authorization
Medical devices are classified into five risk categories (A Non-Measuring/Sterile, A Measuring/Sterile, B, C, D). The classification determines the application fees and the complexity of the review process.
| Classification Type | Plant Master File (PMF) Fee (USD) | Device Master File (DMF) Fee (USD) | Authorization Pathway |
|---|---|---|---|
| Class A (Measuring/Sterile) | $1,000 | $50 | MD-14/15 Import License |
| Class B | $2,000 | $1,000 | MD-14/15 Import License |
| Class C | $3,000 | $1,500 | MD-14/15 Import License |
| Class D | $3,000 | $1,500 | MD-14/15 Import License |
| Class A (Non-M/S) | Exempted | N/A | Online Registration/Self-Certification Only |
The typical review time for MD-14 applications (for Classes B, C, and D) is generally 6 to 9 months.
📑 Required Master Files for Import
The Import License application (MD-14) requires the submission of two primary dossiers for each application package:
- Device Master File (DMF): A comprehensive dossier for each product, demonstrating its safety and efficacy. The registration process heavily relies on the assessment of the device's existing approval from its Home Country and a Reference Country (e.g., USA, EU, UK, Canada, Australia, Japan). Special attention is paid to the predicate device comparison to establish equivalence.
- Plant Master File (PMF): A detailed file describing the manufacturing facility's Quality Management System.
- QMS Conformity: An ISO 13485 certification is mandatory for the manufacturing site(s).
- License Issuance: One Import License (MD-15) is issued per manufacturing site, listing all approved medical devices manufactured there.
Investigational Devices
Devices that are new to the Indian market in terms of materials, mechanism of action, or intended use are considered Investigational Medical Devices (IMDs). IMD applications often require expert review by a Subject Expert Committee (SEC) and may necessitate additional clinical investigation in India.
License Validity and Responsibilities
- Validity: Import Licenses must be renewed every 5 years. Renewal requires submitting updated documents and paying the current DMF and PMF fees.
- Local License Holder: The local License Holder is the legal interface with the CDSCO. They are granted Power-of-Authority, are listed on local labeling, handle customs clearance, and are responsible for Post-Market Vigilance (PMS), including notifying the CDSCO and Materiovigilance Programme of India (MvPi) of Serious Adverse Events (SAEs).
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 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.