What is Import License MD-15?
According to the Medical Devices Regulations, CDSCO hands out form MD-15 as part of their process for authorizing IVDs or healthcare items entering India. The document MD-14 is utilized to submit an application for obtaining this permit; upon approval of the submission, form MD-15 will be provided as confirmation. An import permit facilitates an Indian buyer or designated representative’s entry into India to acquire healthcare equipment manufactured abroad for commercial use within our country.
Without obtaining an Import License for Medical Devices – specifically MD-15 – you may not lawfully bring into or distribute within India any such products if they comply with necessary regulations. The permit guarantees that the foreign goods meet safety standards, possess excellent qualities, and comply with Indian laws. Additionally, it aids in safeguarding both patients and healthcare providers through regulation of the entry procedure and guaranteeing transparency.
Who Needs It and When?
Should your organization be classified as either an Indian enterprise involved in importing medical devices or acting on behalf of a foreign entity selling such products within India, obtaining this permit is usually necessary for bringing these items onto the country’s territory.
The necessity hinges upon the classification level assigned by medical devices according to Rule 2017 for Class I through IV classifications, each corresponding to varying degrees of hazard.
Key Requirements and Process
An import company needs an approved retail permit within India’s jurisdiction. Essential files needed comprise an overseas firm’s production permit, a Country Originated Sales Authorization (COSA), Device Master Record, Facility Master Document, ISO 13485 certification, among other requirements.
Applications can be made electronically via the CDSCO’s SUGAM system or on their latest interface. Upon completing Form MD-14 along with necessary paperwork, the agency may grant the license via Form MD-15 or deny it citing specific grounds by the deadline outlined.
Fee Structure (Grant of Licence)
For medical devices:
Class A (other than non-sterile/non-measuring):
- Fee per manufacturing site: USD 1,000
- Fee per distinct device: USD 50
Class B:
- Fee per site: USD 2,000
- Fee per distinct device: USD 1,000
Class C or D:
- Fee per site: USD 3,000
- Fee per distinct device: USD 1,500
For IVD (in-vitro diagnostic) medical devices:
Class A or B IVD:
- Fee per site: USD 1,000
- Fee per distinct device: USD 10
Class C or D IVD:
- Fee per site: USD 3,000
- Fee per distinct device: USD 500
Validity
The import permit remains active over an extended period spanning five calendar years since its issuance.
Timeline
The process typically takes 4 to 7 months.
Special Features and Conditions
It designates an Indian representative or buyer for goods produced abroad by manufacturers in specific locations, detailing which healthcare products they cover. An Indian representative oversees every operation conducted by an overseas producer within India.
In certain contexts, the validity of the license extends without expiration until it’s canceled through revocation or surrender; however, its ongoing status depends on continuous payment of an annual retention charge for fiscal intervals lasting five years each.