Government Authority (CDSCO)
The Central Drugs Standard Control Organisation (CDSCO), a Ministry of Health & Family Welfare’s Directorate General of Health Services division, manages medical device registration in India. India’s National Regulatory Authority (NRA) is the CDSCO. Medical devices require close observation since they directly affect public health. To prevent miscommunication or inaccurate information among medical device entities, the regulatory body regulates not only the manufacture or import of devices but also other activities like labeling, packaging, and instructions for use.
Medical Device Regulations in India which a manufacturer or importer needs to keep an eye on:
- The 1940 Drugs and Cosmetics Act and the 1945 Drugs and Cosmetics Rules
- Medical Devices Rules, 2017
- Medical Devices (Amendment) Rules, 2020
Class A medical device
Medical devices classified as class A are considered low-risk. CDSCO requires a manufacturer’s license from any business that plans to produce these medical devices for retail or distribution. Examples are stethoscopes and weight scales with body composition.
Class B medical device
Medical devices classified as class B are considered Low-moderate risk. CDSCO requires a manufacturer’s license from any business that plans to manufacture or import these medical devices for retail or distribution. Class B medical devices include contact lenses, contact lens disinfecting solutions, pulse oximeters, cannulas, etc.
Forms for Class A and B notified medical devices:
| FORMS | DESCRIPTION |
|---|---|
| Form MD-3 | Application form to manufacture. |
| Form MD-4 | Application form for loan license. |
| Form MD-5 | Permission to manufacture. |
| Form MD-6 | Permission for loan license. |
| Form MD-12 | Application for a test license |
| Form MD-13 | Permission for a test license |
Manufacturing license or loan license to manufacture Class A (other than non-sterile and non-measuring)
| Subject | Fees (in rupees) INR |
|---|---|
| (a) one site; | 5000 |
| (b) each distinct medical device | 500 |
Manufacturing license or loan license retention fee for Class A (other than nonsterile and non-measuring)
| Subject | Fees (in rupees) INR |
|---|---|
| (a) one site manufacturing | 5000 |
| (b) each distinct medical device | 500 |
Manufacturing license or loan license to manufacture Class B medical devices for
| Subject | Fees (in rupees) INR |
|---|---|
| (a) one site manufacturing | 5000 |
| (b) each distinct medical device | 500 |
| Test license to manufacture for clinical investigations, tests, evaluations, examinations, demonstrations, or training for each distinct medical device. | 500 |
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 send a preliminary approval email and any queries raised.
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.
- To manufacture class A and B, the MD-4 form must be completed with accurate information.
- Upload the documents.
- Fee payments by CDSCO getting mail regarding a license’s approval or rejection.
How to Get a Medical Device Manufacturing License from CDSCO Step-by-Step:
Find Out 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 raise queries 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 CDSCO will give 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.
Documents for Class A and B notified medical devices:
| Documents required from the manufacturer. |
|---|
| 1. Cover letter |
| 2. Fees challan |
| 3. Constitution details of the manufacturing firm or authorized agent |
| 4. The Establishment /Site Ownership/Tenancy Agreement. |
| 5. Copy of Duly notarized valid copies of Quality Certificate in respect to manufacturing site(s), if any; |
| 6. Certificate copy supporting quality management system (ISO: 13485), if any; |
| 7. Plant master file |
| 8. Device master file |
| 9. Test license (for the domestic manufacturer) |
| 10. Undertaking that the manufacturing site complies with the quality management system. |
How Medfins International will assist you
Medfins, with its extensive experience and expertise in regulations around the world, is well-equipped to assist manufacturers in registering Class A and B medical devices in India. Here’s how Medfins can help streamline Class A and B medical device registration:
In-depth Knowledge of Regulatory Landscape:
Medfins comprehensively understands the Indian regulatory framework, including the requirements outlined by the Central Drug Standard Control Organisation (CDSCO). This knowledge ensures manufacturers receive accurate guidance tailored to Class A and B medical device criteria.
Initial Assessment and Classification:
Medfins can conduct an initial assessment to determine if your medical device falls within the Class A and B categories according to CDSCO definitions. This is a crucial step in understanding the regulatory pathway and requirements applicable to your device.
Documentation Preparation:
The team at Medfins will guide manufacturers in preparing the necessary documentation, ensuring that all required information is accurate and compliant with CDSCO regulations.
Form Submission and Communication:
Medfins can assist in submitting the completed forms to the CDSCO and facilitate communication with the regulatory authorities on behalf of the manufacturer. This ensures that the submission process is efficient and that any queries or additional information requests are promptly addressed.
Audit Preparation and Support:
In cases where manufacturing sites require an audit, Medfins can assist in preparing for the audit by ensuring that the site complies with the necessary standards, such as ISO 13485. This proactive approach helps manufacturers navigate the audit process smoothly.
Adaptation to Regulatory Changes:
Medfins stays abreast of any updates or changes in the regulatory landscape. This ensures that manufacturers receive timely information and can adapt their processes to comply with new requirements, keeping their registrations current and compliant.
The regulatory framework for medical devices in India, overseen by the Central Drug Standard Control Organisation (CDSCO), is crucial in ensuring the quality, safety, and proper functioning of low-risk medical devices. Classifying devices into risk categories allows for a tailored regulatory approach, ensuring that the regulatory burden is commensurate with the potential risks associated with these devices. This benefits manufacturers by expediting market entry and provides continued oversight to safeguard public health.