India regulates the Import, Manufacture, Sale, Distribution, and Clinical Performance of In-Vitro Diagnostic (IVD) Medical Devices under the Medical Device Rules 2017, effective from January 1, 2018. Diagnostic kits manufactured in India must obtain a license from either the State Licensing Authority (SLA) or the Central Licensing Authority (CLA), based on their classification. However, importing diagnostic kits from foreign countries requires an import license from the Central Licensing Authority (CDSCO). In vitro diagnostic medical devices are classified by risk and complexity:
- Class A: Low risk
- Class B: Low-moderate risk
- Class C: Moderate-high risk
- Class D: High risk
Transparon can assist you in complying with CDSCO requirements and help you start selling your In-Vitro Diagnostic (IVD) devices in the Indian market. We offer the following services:
1. Manufacturing License Approval from SLA/CLA
State Licensing Authorities (SLA) oversee Class A & B In-Vitro Diagnostics (IVDs) applications, while the Central Licensing Authority (CLA) reviews Class C & D applications. Upon approval, SLA grants licenses via Form MD-5, and CLA issues licenses via Form MD-9. We specialize in dossier compilation under MDR 2017 to help secure manufacturing licenses.
2. Import License Approval from CLA
Foreign manufacturers must obtain an import license through an authorized agent before importing IVDs into India. Applications are submitted via Form MD-14, and the license is issued in Form MD-15. RBridge facilitates this process efficiently.
3. Test License
Manufacturers and importers need a test license for testing, evaluation, or clinical investigation of IVDs. Applications are submitted via Form MD-12 (manufacture) or Form MD-16 (import), with approvals granted in Form MD-13 and Form MD-17, respectively.
4. New IVD Clinical Performance Evaluation
Before manufacturing/importing a new IVD, a clinical performance evaluation must be conducted. Applications are submitted via Form MD-24, and approval is issued in Form MD-25. We ensure precise application preparation and timely approvals.
5. New IVD Manufacturing/Import Permission
New IVDs without a predicate device in India need approval for manufacture or import. Applications are submitted using Form MD-28, and permission is granted via Form MD-29. We assist with accurate application submissions to secure necessary approvals.
6. Performance Evaluation of In-Vitro Diagnostic Medical Devices
Manufacturers of Class B, C, or D IVDs must submit a performance evaluation report issued by accredited Indian laboratories or government-approved institutions. RBridge ensures compliance with these requirements to facilitate license approval.
