Industry
Import license [Form MD-15]
Get professional support for obtaining import license for Medical Devices, Software, Spare Parts, Components & Accessories.
Overview
An import license is required to import the medical devices and its spare parts, components and accessories into India. It is issued by Central Drugs Standard Control Organization (CDSCO) in Form MD-15.
Services
Before making an import license application, the applicant should do an honest assessment of the strengths and weaknesses of the application, understand the regulator’s expectations, and take pragmatic decisions based on ground realities, industry practices and past precedents.
We provide end-to-end services for obtaining an import license, which includes:
- MD-14 application filing (Fresh, endorsement and retention applications)
- Plant Master File (PMF) preparation / review
- Device Master File (DMF) preparation / review
- Online portal account creation
- Predicate search, predicate comparison and analysis
- Risk classification evaluation
- Grouping evaluation
- Official queries response / post-application support
- Post approval compliances support
Process
There are generally five steps to obtaining an import license.
- 1
Account creation
Creation of company account on the online portal of CDSCO.
- 2
Application
Submission of application form in Form MD-14 along with the list of documents.
- 3
Fees
Payment of government fees through the online portal.
- 4
Query resolution
Response to the queries raised by CDSCO (if any).
- 5
License
Grant of import license in Form MD-15.
Timeline
The prescribed timeline for issuance of import license is nine (9) months from the date of application. However, the timeline is suspended if a query on the application is raised by CDSCO.
Validity
Import License is valid in perpetuity unless cancelled or surrendered, provided the retention fee for each foreign manufacturing site and each licensed medical device is paid after every five (5) years.
Key documents required
- Plant Master File
- Device Master File
- Free sales certificate
- ISO 13485 certificate
- Test reports
Fees
Fee [Medical devices]
The Government fee depends on the risk class of the medical device. The medical devices are categorized into the following risk classes:
· Class A (Low risk medical devices)
o Manufacturing site / plant fee: $1000 (per site)
o Medical device fee: $50 (for each distinct medical device / per device)
· Class B (Low-moderate risk medical devices)
o Manufacturing site / plant fee: $2000 (per site)
o Medical device fee: $1000 (for each distinct medical device/ per device)
· Class C (Moderate-high risk medical devices)
o Manufacturing site / plant fee: $3000 (per site)
o Medical device fee: $1500 (for each distinct medical device/ per device)
· Class D (High risk medical devices)
o Manufacturing site / plant fee: $3000 (per site)
o Medical device fee: $1500 (for each distinct medical device/ per device)