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What is an Import License?
India and its healthcare market is rapidly growing. The large population of global manufacturers are attracted to this large market and aiming to sell their medical devices in India. However, the import of medical devices in India requires a mandatory regulatory framework. It enables a hassle-free import of medical devices and allows to keep a check on the quality of the imported medical products in India.
Registration and import license are binding requirements for importing medical devices per CDSCO guidelines. Therefore, any foreign manufacturer who intends to export medical products into the Indian markets must possess a registration certificate and an import license from a local authorized agent.
All these actions related to medical devices, such as their manufacturing, import, export, sale and distribution, are governed by the Drug and Cosmetic act 1940 and Rules 1945.
What is Form MD 14 and MD 15?
Forms MD-14 and MD-15 are the primary documents required for obtaining the import license for medical devices.
Form MD-14 is the application form filled and submitted at an online portal of CDSCO to get permission to import Class A-D medical devices.
Form MD-15 is the license approved by the CDSCO to import medical devices in India as per their classifications A, B, C and D.
Who Can Apply for Import License?
An authorised Indian agent is appointed who acts on behalf of the company. It is a local person in India who the manufacturer authorises to play an important role in the registration process and be responsible for all local business activities, post-market surveillance and certification.
The agent must possess a manufacturing or wholesale license (for sale or distribution) i.e., Form 20 B and Form 21 B as per the CDSCO guidelines. The agent will make an application on behalf of the foreign company for the grant of the import license by applying through the CDSCO-authorised online portal -SUGAM.
How to Apply for Import License?
The process of the approval for ‘Permission to Import Medical Devices’ from CDSCO is regulated under the Medical Device Rules, 2017.
- The company should evaluate all products as per registrations of MDR 2017.
- The evaluation of Class A, Class B, Class C and Class D medical devices is based on the risk associated with each device.
- The company needs to prepare the documents as per the checklist of Form MD-14.
- The company must appoint an authorised local agent to file an online application form.
- These agents will act on their behalf and carry out the regulatory process, from making the application draft to taking the follow-ups from the regulatory Authority and handling queries.
- If the authority finds all the documents in line, the Medical Device Import License is approved by CDSCO in Form MD-15.
- The procedure for obtaining is a Government process and the timeline to receive the import license for medical devices is around six-nine months.
Essential Documents for Import License
The following list of documents is essential while applying for an import license:
- Device Master File
- Site Mater File
- Power of Attorney
- Wholesale License (Authorised Agent)
- Free SALE Certificate form GHTF
All the mandatory documents needed for permission to get the medical device import license must comply with the format prescribed in the Medical Device Rules, 2017.
Fees involved in Import License?
Medical Devices Rules, 2017 classifies each medical device into different categories (Class A to Class D) based on the risk associated with each device. Therefore, the following fee structure grants an import license for each medical device class.
Class A medical devices: The import license fee for each medical device for the Class A category other than IVD medical devices cost $50.
Class B medical devices: The import license fee for each Class B medical device other than IVD medical devices cost $1000.
Class C-D medical devices: The import license fee for each distinct Class C or Class D medical device other than IVD medical devices costs $1500.
Validity for Import License?
The Import License is issued in Form MD-15 and the grant of permission remains valid permanently. One should ensure that the payment of the license retention fee is made from time to time, as mentioned in the Second Schedule, before completion of the period of five years from the date when the license was issued, or it may get suspended or cancelled by the Central Licensing Authority.
