Overview of IVD Device Manufacturing License
The In-Vitro Diagnostic (IVD) Device Manufacturing License is issued by the Central Drugs Standard Control Organization (CDSCO) under the Medical Device Rules, 2017. It is mandatory for manufacturers of diagnostic kits, reagents, and instruments used for detecting diseases or health conditions. Corporate Analytica assists businesses in obtaining CDSCO manufacturing licenses for Class A, B, C, and D IVD devices across India.
Advantages of CDSCO IVD Manufacturing License
- Legal authorization to manufacture diagnostic medical devices in India
- Builds trust among doctors, labs, and healthcare providers
- Eligibility to supply to hospitals, government tenders, and export markets
- Enhances product reliability and market competitiveness
- Ensures compliance with national and international quality standards
Eligibility Criteria
- Registered manufacturing unit with adequate infrastructure
- Quality Management System in place (ISO 13485 preferred)
- Qualified Technical Staff (as per MDR 2017 requirements)
- Product must fall under Class A, B, C or D IVD classification
- Indian Entity or Authorized Indian Agent (for foreign applicants)
Documents Required
- Site Master File and Device Master File
- Valid ISO 13485 Certificate (if available)
- Undertaking on Non-Hazardous Materials (where applicable)
- Proof of Premises Ownership or Rent Agreement
- List of Equipment and Machinery
- Details of Technical Staff and Qualification Certificates
- Product Labels, Testing Protocols & Specifications
Application Process
- Step 1: Determine device classification (A to D)
- Step 2: Prepare all technical and site-related documentation
- Step 3: File online application via CDSCO SUGAM portal
- Step 4: Pay applicable government fee
- Step 5: Site Inspection and Review by CDSCO/State Authority
- Step 6: Grant of Manufacturing License
Why Choose Corporate Analytica?
- Expert guidance on device classification and documentation
- Dedicated support throughout CDSCO portal registration
- Assistance in technical file compilation and QMS implementation
- Coordination with regulatory officials and inspectors
- Proven success in Class A to D IVD license approvals
Post‑License Compliance
- Maintain updated device master files and batch records
- Annual retention fee and record submission to CDSCO
- Implement and maintain Quality Management System (QMS)
- Compliance with Medical Device Rules, 2017 amendments
- Product testing, labeling, and adverse event reporting
Frequently Asked Questions (IVD Manufacturing License)
Q1. Who needs a CDSCO IVD Manufacturing License?
Any company engaged in the production of diagnostic medical devices like test kits, reagents, or instruments in India must obtain this license.
Q2. What is the validity of the license?
The license is valid perpetually, subject to payment of retention fee every five years and compliance with ongoing regulatory norms.
Q3. How long does the approval process take?
For Class A/B devices, approval may take 30–60 days; for Class C/D devices, it may take 3–6 months depending on inspection and file completeness.
Q4. Is ISO 13485 mandatory for this license?
While not mandatory for Class A/B, ISO 13485 is strongly recommended and generally required for Class C/D medical device manufacturing.