MD-15 Import License: In the constantly evolving regulatory landscape of India, obtaining an Import License for medical devices is an important step for manufacturers looking to enter the market. Since the implementation of the Medical Device Rules, 2017, all medical devices and In Vitro Diagnostics (IVDs) require classification and a subsequent Importer License, classified as Class A, B, C, or D, to be marketed in India. This blog offers a concise overview of the necessary steps and documentation required to navigate the CDSCO‘s regulatory environment successfully. This blog provides an overview of the necessary steps and documentation required to navigate CDSCO’s regulatory environment successfully with the help of Morulaa, a consultant in medical device registration in India.
Obtaining an MD-15 Import License in India:
In India, the Authorized Indian Agent also acts as the Legal Importer, applying for the Import License using the MD-14 form via the SUGAM portal. Upon approval, they receive the MD-15 Import License, marking them as the device’s importer. The application process involves several key steps, all of which require understanding the CDSCO’s regulatory framework:
- Assigning power of attorney to the Indian Agent.
- Filling out the MD-14 form on the SUGAM portal.
- Document submission according to the device’s class.
- Fee payment.
- Addressing any queries.
- Undergoing an MDAC review for innovative products.
- Acquiring the MD-15 Import License.
- Exporting medical devices to India.
Essential Documentation for MD-15 Import License:
When seeking the Indian license, applicants must prepare specific documents according to CDSCO guidelines:
- Plant Master File
- Device Master File
- Predicate Table (comparable to the substantial equivalent devices in the Clinical Evaluation Report)
Manufacturers with approval from a GHTF country typically possess the necessary documentation, facilitating the application for the MD-15 Import License based on the device’s classification. A detailed checklist can be found on the following Link.
Maintaining License Validity through Post-Approval Compliance:
After submission and successful query resolution leading to the acquisition of the MD-15 Import license, the manufacturer is required to consistently update device and production site information, adhering to the Import License’s requirements. This ensures the perpetual validity of the license, requiring only a retention fee payment every five years and streamlining license renewal. Neglection of post-approval compliances can result in the manufacturer having to repeat the entire registration process after 5 years.
Conclusion:
Apart from the MD-15, manufacturers also need to adhere to additional product-specific licenses, such as Electronic Waste Disposal and BIS Certificates, Plastic Waste Management, Price Control etc. Morulaa supports in ensuring these compliances are maintained enabling a smooth commercial process in India. To know more, contact us on [email protected] or Click Here.