CDSCO Registration and Classification
The Central Drugs Standard Control Organization (CDSCO) is the regulatory authority responsible for regulating pharmaceuticals and medical devices in India. CDSCO plays a crucial role in ensuring the safety, efficacy, and quality of drugs and medical devices available in the Indian market.
1. CDSCO Classification for Medical Devices: The classification takes into account factors such as intended use, duration of contact with the body, and potential harm to the patient. The classification includes Class A, B, C, and D devices, with Class D representing the highest risk.
New Device
| Applicant | Risk / Class | Type of License | Forms |
|---|---|---|---|
|
Importer |
A, B, C,&D |
Clinical Investigation
Permission |
Application MD- 22,
Permission MD- 23 |
|
A, B, C,&D |
Import License |
Application MD- 26, Permission MD- 27 |
|
|
A, B, C,&D |
Test License |
Application MD- 16, Permission MD- 17 |
|
|
Manufacturer |
A, B, C,&D |
Clinical Investigation
Permission |
Application MD- 22, Permission MD- 23 |
|
A, B, C,&D |
Manufacturing License |
Application MD- 26, Permission MD- 27 |
|
|
A, B, C,&D |
Test License |
Application MD- 16, Permission MD- 17 |
Existing Device
| Applicant | Risk / Class | Type of License | Forms |
|---|---|---|---|
|
Importer |
A, B, C,&D |
Import License |
Application MD- 14, Permission MD- 15 |
|
Manufacturer |
A, B |
Manufacturing
License |
Application MD- 3, Permission MD- 5 |
|
Loan License |
Application MD- 4, Permission MD- 6 |
||
|
C, D |
Manufacturing
License |
Application MD- 7, Permission MD- 9 |
|
|
Loan License |
Application MD- 8, Permission MD- 10 |
2. CDSCO Regulatory Approvals and Documentation:
a. Clinical Trials: Pharmaceutical companies conducting clinical trials in India must obtain approval from CDSCO’s Drug Controller General of India (DCGI). Detailed protocols, safety data, and ethical approvals are required.
b. Import and Export Licenses: For the import or export of pharmaceuticals or medical devices, companies must obtain appropriate licenses from CDSCO.
c. Product Labeling and Packaging: CDSCO has specific requirements for product labeling and packaging to ensure that information provided to healthcare professionals and consumers is accurate and in compliance with regulations.
3. Post-Market Surveillance: Companies are required to report adverse events and maintain quality standards throughout the product’s lifecycle.
Note: For medical device registration in India, companies should stay updated with evolving CDSCO regulations and may need to adhere to specific import and regulatory requirements.
Registration Flow for Importers and Manufacturers
1. Register in the Sugam online Portal on the CDSCO website.
2. Pay the Prescribed Fees.
3. Submit the online application- Complete and submit Form MD-14 online, providing essential information about the applicant, product details, power of attorney, relevant certificates, and a Device and Site Master File.
4. Review and Evaluation- Once all the necessary steps have been completed and the submitted documents are found satisfactory, the concerned department will issue the Medical Import License in Form MD-15.
5. Testing and Analysis: Depending on the nature of the product, CDSCO may require samples of imported pharmaceuticals or medical devices to be tested and analyzed in accredited laboratories to verify their quality and safety.
6. Registration Certificate: Upon successful evaluation and compliance with the requirements, CDSCO may issue a Registration Certificate to the importer. This certificate authorizes importing and selling the specific pharmaceutical or medical device in India.
7. Import and Customs Clearance: With the Registration Certificate, the importer can proceed with the actual importation of the products. Importers need to adhere to customs clearance procedures and comply with relevant customs regulations.
8. Post-Import Compliance: Importers are required to ensure ongoing compliance with CDSCO regulations and any other relevant regulations. This includes adhering to labeling and packaging requirements, maintaining quality standards, and reporting adverse events or other relevant information to CDSCO as necessary.
Registration Flow for Local Manufacturers
1. Application for the license for manufacture of these notified devices in India shall be made in Form 27.
2. 60 days of time would be given for making the application for manufacture from the publication date of these guidelines.
3. The applicant shall provide the following details along with the application to the licensing authority.
- Name of the company, address, and other details
- Material Construction
- Intended use
- Product Specification
- Product Literature
- Packaging insert along with samples and promotional literature
4. The SLA State Licensing Authority after verification and inspection, will forward the license to CLAA Central Licensing Approving Authority. Note: Class A & B devices are approved by SLA and Class C & D has to be approved by CLA.
5. Apply for the Free Sale Certificate (FSC).
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