Class A and B Loan License to Manufacture for Sale or for Distribution of Class A Class B Medical Device Registration In India
The Central Drugs Standard Control Organisation (CDSCO), under the Ministry of Health & Family Welfare’s Directorate General of Health Services, is India’s National Regulatory Authority responsible for medical device registration.
Key Indian Medical Device Regulations:
- The Drugs and Cosmetics Act, 1940 and The Drugs and Cosmetics Rules, 1945
- Medical Devices Rules, 2017
- Medical Devices (Amendment) Rules, 2020
Classification of Medical Devices:
Class A (Low-Risk Devices):
- Medical devices classified as Class A pose minimal risk.
- Manufacturers must register with CDSCO for manufacturing and distribution.
- Examples: Tongue depressors, stethoscopes, etc.
Class B (Low to Moderate Risk Devices):
- Class B devices have a slightly higher risk than Class A.
- Manufacturers require a CDSCO manufacturing license for retail or distribution.
- Examples: Electrocardiographs, nebulizers, digital thermometers, etc.
The forms required for Manufacturing License in case of class A and B notified medical devices:
Applicant type
Applicant Type | Application | License |
Manufacturer | Form MD-4 | Form MD-6 |
Test License | Form MD-12 | Form MD-13 |
Fee Structure:
Subject | Fee (in rupees) INR |
Manufacturing licence or loan licence to manufacture Class A (other than non-sterile and non-measuring) or Class B medical device for,- | |
one site manufacturing | 5000 |
each distinct medical device | 500 |
Test license to manufacture for clinical investigations, tests, evaluations, examinations, demonstrations, or training for each distinct medical device | 500 |
Phases for Manufacturing License Registration
- Application for a Manufacturing Test License from CDSCO
A CDSCO- MD 13 (Licence to Manufacture Medical Devices for the Purposes of Clinical Investigations or Test or Evaluation or Demonstration or training) is required to produce small, high-quality medical devices for personnel testing, evaluation, demonstration, and training.
Process:
- NSWS Portal Registration
- Filling and Submitting Form MD-12
- Complete the MD-12 application form
- Submit the required documents
- Application Review and Approval
Timeline: 1–2 months (After Submission of application on the NSWS Portal)
Validity: 3 years
- Registration of Applicant for CDSCO Manufacturing License
To register an applicant for a CDSCO (Central Drugs Standard Control Organization) manufacturing license in India, follow these steps:
Create an Account on CDSCO’s SUGAM Portal
- Visit the SUGAM portal
- Click on Sign Up Here and select Manufacturer as the applicant type.
- Fill in the required details (company name, authorized person details, email, phone number, etc.).
- Upload the required documents (Company PAN, GST certificate, etc.).
- Submit for verification.
Process:
Step 1: Determine Medical Device Classification
- CDSCO classifies medical devices into four categories (Class A, B, C, and D) based on risk level.
- The classification determines the regulatory requirements and level of scrutiny.
Step 2: Prepare Technical Documentation
Ensure compliance with CDSCO requirements by compiling:
- Device specifications
- Safety and performance data
- Manufacturing process details
- Risk management reports
- Labelling and intended use description and etc.,
Step 3: Online Application Submission
- Submit the application form on the CDSCO portal.
- Upload corporate details, supporting documents, company registration, QMS certificates, and technical documentation.
Step 4: Initial Review by the State Licensing Authority (SLA)
- The SLA verifies the application for completeness.
- If approved, the application is forwarded to a Notified Body for assessment.
Step 5: Audit by the Notified Body
- The Notified Body reviews documents and conducts an on-site audit of the manufacturing facility.
- The audit ensures compliance with QMS and regulatory requirements per the 4th and 5th Schedules of the Indian Medical Device Rules, 2017.
Step 6: Evaluation and Query Resolution
- The Notified Body may raise queries or note non-conformities.
- The applicant must address queries and implement corrective actions.
Step 7: Issuance of Form MD-11
- After satisfactory resolution of queries, the Notified Body issues Form MD-11, documenting the audit and inspection process.
Step 8: Final Review and License Issuance
- The SLA reviews Form MD-11 and all submitted documents.
- If compliant, the SLA grants the manufacturing license for Class A and B medical devices.
Timeline: 150 – 160 days (After Submission of application on the CDSCO Portal)
Manufacturing License Validity: 5 years
Required Documents for Class A & B Notified Medical Devices:
- Cover Letter
- Fee Payment Proof
- Firm’s Constitution Documents
- Establishment/Site Ownership or Tenancy Agreement
- ISO 13485 Certificate (Quality Management System)
- Plant Master File
- Device Master File
- Test License
FAQ:
- Can a Loan Licensee sell products directly to the market?
Yes, but they must comply with labelling, distribution, and post-market surveillance regulations as per the Medical Device Rules, 2017. - What post-market surveillance responsibilities does a Loan Licensee have?
A Loan Licensee must:
- Report adverse events
- Ensure product traceability and recall procedures.
- Submit periodic post-market surveillance data if required.
How can Medfins help you?
As a regulatory consultant, our role in the CDSCO manufacturing license registration process includes:
- Applicant Registration Support
- Assisting with SUGAM portal registration and ensuring proper documentation submission.
- Verifying the company details, manufacturing site information, and authorized signatory details.
- Regulatory Documentation Preparation
- Preparing and reviewing the Manufacturing License Application (Form MD-4).
- Assisting with the Device Master File (DMF) and Site Master File (SMF).
- Ensuring compliance with ISO 13485 and GMP requirements.
- Providing guidance on the risk classification of medical devices.
- Liaison with Regulatory Authorities
- Coordinating with CDSCO and State FDA for approvals.
- Handling queries, deficiency letters, and compliance responses.
- Ensuring smooth audit/inspection readiness for Notified Body Audits.
- Post-Approval Compliance
- Ensuring Post-Market Surveillance (PMS) and Adverse Event Reporting compliance.
- Supporting renewals and modifications of licenses.