CDSCO Registration Online Process, Documents, Cost
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CDSCO Registration - Online Procedure, Documentation, Benefits, Fee etc.
CDSCO stands for Central Drugs Standard Control Organization, India’s National Regulatory Authority (NRA) for Cosmetics, Pharmaceuticals, and Medical Devices. As a highly influential organization in India, it specializes in CDSCO Registration.
Under the CDSCO, the Drug Controller General of India (DCGI) oversees Pharmaceuticals and Medical Devices, operating within the Ministry of Health and Family Welfare. Import, manufacturing, sale, and distribution of drugs are regulated in India under the Drugs and Cosmetics Act 1940 and Rules 1945.
What is the Central Drugs Standard Control Organisation?
CDSCO, the Central Drugs Standard Control Organisation, is India’s National Regulatory Body for Cosmetics, pharmaceuticals, and medical devices. It is a highly powerful organization in India and operates under the Directorate General of Health Services, Ministry of Family Welfare & Health, and the Government of India.
The Indian Government has announced its plan to bring all medical devices, including implants and contraceptives, under the review of the Central Drugs Standard Control Organisation. CDSCO, along with state regulators, is responsible for granting licenses for certain specialized categories of critical drugs, such as Blood and Blood Products, I.V Fluids, Vaccine & Sera.
What is CDSCO Registration?
CDSCO Registration is the pivotal approval process from the Central Drugs Standard Control Organisation, assuring the quality and efficacy of Pharmaceuticals, Medical Devices, and Cosmetics. It guarantees that these products are devoid of harmful elements, ensuring no harm to animals during production, and certifies their safety for public use.
Who can Apply for CDSCO Medical Registration In India?
- Manufacturer having a registered office in India.
- The Authorized Agent of the Manufacturer.
- Foreign Enterprises holding Indian Subsidiary.
- Corporates.
- Any other Importers.
Necessary documents required CDSCO Registration
Documents required in CDSCO Registration are as follows:
- Form MD 1.
- Identity and Address Proof of the Applicant.
- Covering Letter.
- Description of the Product.
- Test Protocol.
- Quality Certificates.
- Instructions for Use.
- Undertaking from the Government Authority.
- Fee Challan.
- Legal Form.
- ISO-13485.
- PMS Surveillance
Fees required in CDSCO Registration for License
| Device Type | Governmental Fee | Professional Fee |
|---|---|---|
| Manufacturing of Medical Equipment | ||
| Class A and Class B | ₹5000 (one site), ₹1000 (each distinct medical device) | ₹99,999/- |
| Class C and D | ₹50000 (one site), ₹1000 (each distinct medical device) | ₹99,999/- |
| Import of Medical Equipment | ||
| Class A | $1000 (one site), $50 (each distinct medical device) | ₹99,999/- |
| Class B | $2000 (one site), $1000 (each distinct medical device) | ₹99,999/- |
| Class C and D | $3000 (one site), $1500 (each distinct medical device) | ₹99,999/- |
| Class A and B in vitro diagnostic | $1000 (one site), $10 (each distinct) | ₹99,999/- |
| Class C and D in vitro diagnostic | $3000 (one site), $500 (each distinct) | ₹99,999/- |
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