CDSCO – The Government Authority Medical device registration in India is overseen by the Central Drugs Standard Control Organisation (CDSCO), a Ministry of Health & Family Welfare’s Directorate General of Health Services division. The CDSCO is India’s National Regulatory Authority (N.R.A.).
• Indian Regulations for Medical Devices
· The Drugs and Cosmetics Rules of 1945 and the Drugs and Cosmetics Act of 1940
· 2017 Medical Devices Rules
· Medical Devices (Amendment) Rules, 2020
• Medical device status: As of April 1, 2020, all medical devices outside the original 23 notified must be registered under The Drugs and Cosmetics Act of 1940. By October 1, 2023, all Class C and D devices that haven’t been notified must have import licenses.
Class C medical device – Medical devices classified as class C are considered moderately high risk. CDSCO requires a manufacturer’s license from any business that plans to manufacture these medical devices for retail or distribution. Examples are Blood bags, syringes, etc.
Class D medical device – Medical devices classified as class D are considered High risk. CDSCO requires a manufacturer’s license from any business that plans to manufacture or import these medical devices for retail or distribution. Examples are Spinal needle bioimpedance, etc.
The forms required for import License/Manufacturing in case of class C and D notified medical devices:
Applicant type
| Applicant type | Application | License |
| Manufacturer | Form MD-7 | Form MD- 9 |
| Manufacturer (Loan License) | Form MD- 8 | Form MD- 10 |
| Test license | Form MD -12 | Form MD -13 |
Fee structure:
| Subject | Fees (in rupees) INR |
| Manufacturing license or loan license to manufacture Class C medical device for,- | |
| (a) one site; | 50000 |
| (b) each distinct medical device | 1000 |
| Manufacturing license or loan license to manufacture Class D medical devices for,- | |
| (a) one site; | 50000 |
| (b) each distinct medical device | 1000 |
| Manufacturing license or loan license retention fee for | |
| (a) one site of manufacturing Class C medical devices; | 50000 |
| (b) each distinct medical device of Class C. | 1000 |
| Manufacturing license or loan license retention fee for | |
| (a) one site of manufacturing Class D medical devices; | 50000 |
| (b) each distinct medical device of Class D. | 1000 |
| Test license to manufacture for clinical investigations, tests, evaluations, examinations, demonstrations, or training for each distinct medical device. | 500 |
Phases for manufacturing license registration:
Registration of Applicant for CDSCO Manufacturing License
To generate login credentials for the CDSCO manufacturing license registration process, you must upload the necessary documents to the CDSCO portal.
Process:
- Filling out an online CDSCO form.
- Uploading corporate information and documents.
- Following submission of the form, CDSCO will raise any queries.
Application for a Manufacturing Test License from CDSCO
To produce small, high-quality medical devices for personnel testing, evaluation, demonstration, and training, a CDSCO manufacturing test license is needed.
How to Apply:
- Use an online application portal.
- MD-12 Form packed with accurate information, putting papers online.
- Payment of fees.
- Modification in the application’s status.
Application for a Manufacturing License from CDSCO.
One must apply for a manufacturing license from CDSCO to manufacture medical devices.
Process:
- Using the CDSCO portal to submit an online application.
- The MD-7 form must be completed with accurate information to manufacture class C and D.
- Upload the documents.
- Fee payments by CDSCO are getting mail regarding a license’s approval or rejection.
How to Get a Medical Device Manufacturing License from CDSCO Step-by-Step:
- Find Your Medical Device’s Classification: The CDSCO divides medical devices into four classes based on risk level. The classification of your application will dictate the necessary level of scrutiny.
- Assemble technical documentation: For your medical device, prepare technical documentation that includes the device’s specifications, safety information, manufacturing process, and description. Verify that the documentation satisfies the CDSCO specifications.
- Apply: Send in the CDSCO’s manufacturing license application. The application must contain the necessary fees, a cover letter, and technical documentation.
- Review of CDSCO: Your application and technical documentation will be reviewed by the CDSCO. CDSCO may send out a deficiency letter if it needs more information.
- Inspection of Manufacturing Facility: The CDSCO will inspect your manufacturing facility after reviewing your application. Whether your facility complies with CDSCO regulations will be determined by the inspection.
- Manufacturing License: The organization will award you a manufacturing license if your facility satisfies the CDSCO requirements.
- Renewal of License: The average validity period for a manufacturing license is five years. Your license needs to be renewed before it expires.
Validity –
Manufacturing license – Five years
Documents for Manufacturers of Class C and D notified medical devices:
1. Cover letter
2. Fees
3. Constitution details of the manufacturing firm or authorized agent.
4. The Establishment /Site Ownership/Tenancy Agreements.
5. Copy of Duly notarized valid copies of Quality Certificate in respect to manufacturing site(s), if any;
6. Copy of Certificate supporting quality management system (ISO: 13485), if any;
7. Quality management system as per the medical device rule,2017.
8. Reference for predicate device,
9. Plant master file
10. Device master file
11. Test license (for the domestic manufacturer)
12. Ensure that the manufacturing site complies with the quality management system.
Conclusion -The regulatory landscape for medical devices in India has undergone significant advancements, with the introduction of the Indian Medical Device Rules (IMDR) in 2017 and subsequent amendments in 2020. The Central Drugs Standard Control Organisation (CDSCO), as the National Regulatory Authority (N.R.A.), plays a pivotal role in overseeing the registration and licensing processes. As the healthcare industry evolves, collaboration between stakeholders, including manufacturers, regulators, and regulatory consultants like Medfins, will be essential to refining and enhancing the regulatory framework. This collective effort will align with global standards and position the Indian medical device market as a competitive player on the international stage, fostering growth and development within the healthcare ecosystem.
For further clarification or assistance, call 7042028042 or info@medfinsinternational.