When medical device importers want to sell products in the Indian market, they will need to understand and navigate the CDSCO license requirements from the Central Drugs Standard Control Organization. This comprehensive Guide will detail the requirements, processes, and regulations that govern CDSCO medical device license applications and the importers engaged in the country’s healthcare ecosystem.
What is CDSCO and what authority does it hold?
The Central Drugs Standard Control Organization (CDSCO) is installed as the National Regulatory Authority for India’s Ministry of Health and Family Welfare, which is administered by the Directorate General of Health Services. As the governing authority for medical devices, CDSCO operates like the FDA in the US and the European Medical Agencies. Its mandate is to enforce medical device regulations in a consistent manner and safeguard patient safety and health.
The CDSCO derived its powers from the Drugs and Cosmetics Act 1940 and the Medical Device Rules 2017, which require all medical devices to comply with regulations prescribed under 2017 Indian medical device regulations before it can be sold in India. The CDSCO serves as the Central Licensing Authority for Class C and D devices and it also acts as the authority which oversees the State Licensing Authorities that regulate Class A and B devices.
A medical device classification system
CDSCO utilizes a risk-based classification system that divides medical devices into four classes with respect to potential risk to patients:
Class A (Low Risk): Non-invasive devices with negligible patient contact, i.e. bandages, surgical masks and examination gloves. Class A devices are split into two categories, sterile/measuring and non-sterile/non-measuring.
Class B (Low-Moderate Risk): Non-invasive devices contacting intact mucous membranes, i.e. hypodermic needles, suction devices and aerosol nebulizers.
Class C (Moderate-High Risk): Invasive devices entering the body through orifices or contacting internal body fluids, i.e. bone fixation implants, heart valves and intraocular lenses.
Class D (High Risk): Invasive devices contacting the cardiovascular or central nervous system, or intended for life support, i.e. pacemakers, defibrillators, and stents.
Requirements for CDSCO License
Application Eligibility
Applications for a CDSCO import license can be submitted by various parties, including but not limited to wholesalers, importers, foreign medical device manufacturers (through their appointed authorized agents), research organizations, health care providers, and importers of specialized test kits.
If a foreign manufacturer is applying for an import license, they must appoint an authorized agent in India that has a valid wholesale license (Form 20B/21B) for distributing medical devices. The authorized agent in India is the entity of reference in India as foreign manufacturer and intermediary with CDSCO while the process is taking place.
Necessary Documentation
The CDSCO license requires considerable documentation to demonstrate conformity with regulating bodies and biotechnology safety:
1. Plant Master File (PMF)—A PMF is like a Quality Manual; containing information on how the product is manufactured, administered quality systems and inventory management systems.
2. Device Master File (DMF)—More descriptive technical documentation than the Device Technical File as stated in ISO 13485: 2016.
3. Free Sale Certificate—A free sale certificate shall be a legal document and notarized by the National Regulatory Authority for the Country of Origin declaring legal market authorization.
4. Quality Management Certificates—Standard components of a Quality Management System shall include ISO 13485 certification from the actual manufacturing site.
5. Regulatory Certificates—Documents with CE marking or FDA approvals or similar documents obtained from recognized regulatory authorities.
6. Declaration of Conformity—The manufacturer’s declaration thus confirming the requirements of the appropriate regulatory authorities and standards.
7. Power of Attorney (POA)—The foreign manufacturer’s POA for the Indian agent to act on behalf of the foreign manufacturer.
Application Process
The CDSCO registration process consists of a clear and consistent process through the SUGAM online portal:
1. Account Creation — The applicant must register on the CDSCO SUGAM portal, and verify it.
2. Application Submission — The applicant must complete Form MD-14 providing information about the product in detail and complete submission of all documents.
3. Fees Paid — The applicant must pay the prescribed fees (based on device) for the device on Form MD-14, as specified earlier — between $1000 and $3000 per facility plus additional per device fees, according to device classification, based on earlier discussion.
4. CDSCO Specialized Review — The authority reviews the application to determine if all safety and efficacy requirements are met. These may include questions on the specific item you are submitting or a total review which some new product might be reviewed by the Medical Device Advisory Committee (MDAC).
5. Respond to Queries — The applicant will usually have 45 days to respond to the CDSCO with additional documentation per their questions.
6. Facility Assessments — On occasion, CDSCO may inspect the importing facilities in Canada to ensure quality requirements are being met as described.
7. Issued License — When CDSCO is satisfied with your application they will issue an Import Licence in Form MD-15.
Validity and Renewal of the License
CDSCO medical devices licenses are valid for an indefinite period unless suspended or cancelled. Action must be taken by license holders to keep their status active, however, a retention fee must be paid to CDSCO every five years from the original date of issuance. The fee structure is the same as application fees as made evident by the Medical Devices and Cosmetics Act.
License holders who fail to pay retention fees by the required deadline will have their license cancelled, and will then need to reapply for the licenses that will allow for renewal into that market.
Enforcement and Penalties
License holders of a CDSCO license in India faces serious business and criminal repercussions for violation of the CDSCO license under the Drugs and Cosmetics Act, 1940, and the Medical Devices Rules, 2017. Offences could result in imprisonment and/or fines for importing medical devices with a CDSCO license, or providing false information.
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