The Central Drugs Standard Control Organization (CDSCO) serves as the National Regulatory Authority (NRA) of India for medical devices and in vitro diagnostic (IVD) products. Under the Medical Device Rules (MDR) 2017, CDSCO has established a streamlined regulatory framework to ensure the safety, quality, and performance of medical devices marketed in India. This article provides an overview of the various types of licenses issued by CDSCO based on the nature of the business activity in the medical device sector.
Temporary Licenses
Temporary licenses are primarily issued for research and validation purposes. These licenses enable the development and evaluation of medical devices and investigational products. They are critical for fostering innovation and ensuring the safety and efficacy of devices before market introduction. These licenses are non-renewable and only valid for purpose granted, their validity is not extended in any circumstances.
Key Types:
- Test Licenses:
- Purpose: For testing and evaluation of medical devices, including performance evaluations of IVDs and clinical investigations.
- Regulatory Form: Form MD-12, MD-16
- Clinical Investigation Permissions:
- Purpose: To conduct clinical investigations for high-risk devices (Class C and D).
- Regulatory Form: Form MD-22, MD-24
- Manufacturing Permission for Investigational Devices:
- Purpose: For manufacturing devices intended for use in clinical investigations.
- Regulatory Form: MD-26, MD-28
Commercial licenses are intended for entities involved in the production, sale, and distribution of medical devices. These licenses ensure that the devices marketed in India meet established safety, quality, and performance standards. These licenses can be renewed and subject to perpetuity of the fees paid.
Key Types:
- Manufacturing License:
- Purpose: For manufacturing medical devices intended for sale and distribution.
- Applicable Classes: Class A, B, and Class C, D.
- Regulatory Form: Form MD-3 for Class A and B devices; Form MD-7 for Class C and D devices.
- Requirements:
- A valid Quality Management System (QMS) in compliance with ISO 13485.
- Defined manufacturing site with qualified personnel and equipment.
- Wholesale License:
- Purpose: For entities engaged in the wholesale distribution of medical devices.
- Regulatory Authority: State Licensing Authority (SLA).
- Regulatory Form: MD-41
- Loan License:
- Purpose: For manufacturers who use the facilities of another licensed manufacturer to produce medical devices.
- Regulatory Form: Form MD-4 for Class A and B; Form MD-8 for Class C and D.
- Requirements:
- An agreement between the original and loan license holder.
- Compliance with ISO 13485 standards.
- Import License:
- Purpose: For businesses importing medical devices into India.
- Applicable Classes: All classes (A, B, C, D).
- Regulatory Form: Form MD-15 (application for import license).
- Requirements:
- Device registration in Form MD-14.
- Importer’s authorization from the manufacturer.
- Certificate of Free Sale from the country of origin.
- Declaration of conformity to Indian standards, where applicable.
The Medical Device Rules 2017 have established a comprehensive licensing framework to cater to both research and commercial needs in the medical device sector. Temporary licenses facilitate innovation by supporting research and validation, while commercial licenses ensure the quality and safety of devices intended for public use. Understanding these categories and their specific requirements is critical for businesses to navigate the regulatory landscape and achieve compliance with Indian regulations.
