India has emerged as the world's top manufacturer of medical devices over the past two decades. The Central Drugs Standards Control Organization (CDSCO) is authorised regulatory to approve applications to grant the permission to import medical devices in India. To import notified medical devices, an import license i.e., Form MD-15, must be procured from the CDSCO, as per the Medical Devices Rule, 2017. To import notified medical devices, the manufacturing site and medical devices should be registered with the CDSCO. The Medical Device import license can be obtained by filling Form MD-14 and submitting to the CDSCO. An authorized Indian agent must be appointed for the same. This agent must have a license to manufacture (for sale or distribution) or license to wholesale (sale or distribution) as per the rules. The agent will make an application for the grant of the import license by applying through the Sugam online portal.
An authorized Indian agent must be appointed for the same. This agent must have a license to manufacture (for sale or distribution) or wholesale License FORM 20B & FORM 21 B (sale or distribution) as per the CDSCO guidelines. The agent will make an application to get the grant of medical devices import license by applying through the Sugam online portal.
|Evaluation of the product, if it requires registrations MDR 2017 (Regulated/Non-Regulated)|
|If requires registration, Evaluation of classification (Class A, B, C, & D) based on the product risk category|
|Preparation of documents as per the MD 14 checklist|
|Appoint authorize agent|
|Online generation of application|
|Approval/confirmation of draft application by the authorize agent submission of application.|
|Follow-up with regulatory authority and Query management if any|
|Medical Device Import Approval in India is received|
The permission to import medical device is issued as Form MD 15 remains valid in perpetuity i.e., permanently, as long as the payment of license retention fee is done from time to time, as specified in the Second Schedule. The license retention should be paid each time before completion of the period of 5 years from the date of issue of the license unless it is suspended or cancelled by the Central Licensing Authority.
The Government Timeline for Import License for Medical Device is 6-9 months.
Some Key points, you must pay attention before applying for the permission to medical devices import license.
The Power of Attorney must be submitted in the same format as prescribed in the Medical Device Rules 2017.
The Device Master Files, Site Master Files, and other technical documents need to beprepared as per the format prescribed in MDR 2017.
In case there is no predicate device available in India, the applicant must obtain prior permission in Form MD 27 from the Central LicensingAuthority. No license to an important class of such medical device shall be granted without such permission.
Apostillation and notarization of the particular document must be followed as prescribed in MDR 2017.
CliniExperts professionals strive to provide the unrivalled assistance to streamline the process of licensing and regulatory approvals to Import Predicate Medical Devices as per Medical Devices Rule 2017.
The Power of Attorney needs to be meticulously prepared as this document forms the basis of the entire application of the medical device Import License, India.
The product name and model numbers must be in alignment with the POA, FSC, Label and IFU, and other technical documents.
For Grouping of Products: It is crucial to apply the Grouping Guidelines on Medical Devices issued by the CDSCO. Failure to do the needful may attract additional government fees.
Yes, there can be multiple importers for the same product, however all the applicants should meet the criteria for filling the application.
A new agent has to submit all necessary legal documents like MD 14, the new Power of Attorney, government fees, wholesale or manufacturing licenses, label, IFU, and a copy of the import license issued to the former agent. Additionally, an undertaking from the manufacturer must be submitted stating there is no change in the device master file, plant master file, and other regulatory documents submitted to CDSCO by the previous agent along with their name, address & import license number for registration. When in doubt, take the help of a consultant to make sure your documentation is in place.
As per the Second Schedule, the manufacturer needs to submit the appropriate fees for different classes of the medical devices. If the organization is manufacturing all classes of the product, then the fees pertaining to the higher class need to be paid.
Yes, a change in the Indian authorized agent will require a fresh license application.
The Import license retention fee for various medical devices is as follows:
One overseas site manufacturing Class A medical device other than in vitro diagnostic medical device - $1000; Each distinct medical device of Class A other than in vitro diagnostic medical device -$50.One overseas site manufacturing Class B medical device other than in vitro diagnostic medical device - $2000 ; Each distinct medical device of Class B other than in vitro diagnostic medical device - $1000
One overseas site manufacturing Class C or Class D medical device other than in vitro diagnostic medical device - $3000; Each distinct medical device of Class C or Class D other than in vitro diagnostic medical device - $1500