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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).
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