Overview of In-Vitro Diagnostic (IVD) Device Import License
The IVD Device Import License is a regulatory approval issued by the Central Drugs Standard Control Organization (CDSCO) under the Medical Device Rules, 2017. This license is mandatory for foreign manufacturers and Indian importers intending to import and market in-vitro diagnostic kits and devices in India. Corporate Analytica provides complete support in obtaining the IVD import license, ensuring a smooth regulatory journey.
Advantages of IVD Import License
- Legally enables import and sale of diagnostic devices in India
- Ensures compliance with CDSCO and global standards
- Builds credibility with healthcare providers and regulators
- Faster access to Indian healthcare and laboratory markets
- Facilitates tenders and B2B opportunities
Eligibility Criteria
- Indian entity with valid wholesale/manufacturing license
- Foreign manufacturer registered with competent authority
- Appointed Indian Authorized Agent (IAA) in India
- Product must be classified as an IVD under CDSCO
- Compliance with ISO 13485 or equivalent QMS
Documents Required
- Power of Attorney (legalized/apostilled)
- Free Sale Certificate from country of origin
- Product labels, IFUs, and brochures
- CE Certificate / ISO 13485 / QMS Certificate
- Device Master File (DMF) and Plant Master File (PMF)
- Importer's Drug License (Form 20B/21B or MD-42)
Application Process
- Step 1: Appoint an Authorized Agent in India
- Step 2: Prepare required technical and legal documents
- Step 3: Submit online application on CDSCO SUGAM portal
- Step 4: Pay the applicable government fees
- Step 5: CDSCO review and issue Form MD-15 (Import License)
Why Choose Corporate Analytica?
- Expert guidance from CDSCO import license consultants
- Full support for documentation, portal upload & query handling
- Experienced in handling complex diagnostic product classifications
- Quick turnaround time and transparent communication
- End-to-end support for regulatory registration & renewals
Post‑License Compliance
- Timely renewal of MD-15 Import License
- Maintain product traceability and batch records
- Report adverse events to CDSCO, if any
- Label compliance as per Indian rules
- Audit readiness for CDSCO inspections
Frequently Asked Questions (IVD Import License)
Q1. Who needs an IVD import license in India?
Any foreign manufacturer or Indian entity planning to import in-vitro diagnostic medical devices into India must obtain an IVD Import License (Form MD-15) from CDSCO.
Q2. What is the validity of the IVD Import License?
The license is valid perpetually, subject to payment of retention fees every 5 years and compliance with conditions stated in the license.
Q3. How long does it take to get the license?
The standard processing time is 4 to 6 weeks after submission of complete documents and payment of fees, depending on product class and CDSCO query resolution.
Q4. Can one license cover multiple IVD devices?
No. A separate application must be filed for each IVD device unless they are grouped under a family as per CDSCO grouping guidelines.