In-Vitro Diagnostics (IVD) Regulatory Services
IVDs (In-Vitro Diagnostics) are essential medical devices used for the detection, diagnosis, and monitoring of diseases. These include diagnostic kits, reagents, and laboratory-based testing systems.
BlackBows provides comprehensive regulatory support for IVD manufacturing and import in India, ensuring full compliance with CDSCO requirements through precise documentation, strategic guidance, and seamless execution.
IVD Classification (Class A, B, C & D)
Class A – Low Risk
These devices pose minimal risk and are generally subject to limited regulatory control.
Examples: Laboratory reagents, specimen collection containers.Class B – Low to Moderate Risk
Devices with moderate risk requiring controlled regulatory oversight.
Examples: Pregnancy kits, glucose strips, urine analysis kits.Class C – Moderate to High Risk
Devices requiring stricter regulatory evaluation due to higher risk levels.
Examples: HIV, hepatitis, and oncology diagnostics.Class D – High Risk
Critical devices requiring extensive regulatory scrutiny and approvals.
Examples: Genetic testing, companion diagnostics, life-threatening disease detection.Licensing Framework for IVD Devices
Existing Devices
| Applicant | Risk/Class | Type of Licence | Forms |
|---|---|---|---|
| Importer | A, B, C, D | Importer Licence | MD-14 → MD-15 |
| Manufacturer | A, B | Manufacturing Licence | MD-3 → MD-5 |
| Loan Licence | MD-4 → MD-6 | ||
| C, D | Manufacturing Licence | MD-7 → MD-9 | |
| Loan Licence | MD-8 → MD-10 |
New Devices
| Applicant | Risk/Class | Type of Licence | Forms |
|---|---|---|---|
| Importer | A, B, C & D | Clinical Performance Evaluation | MD-24 → MD-25 |
| Import Licence | MD-26 → MD-27 | ||
| Test Licence | MD-16 → MD-17 | ||
| Manufacturer | A, B, C & D | Clinical Investigation Permission | MD-22 → MD-23 |
| Manufacturing Licence | MD-26 → MD-27 | ||
| Test Licence | MD-16 → MD-17 |
How IVDs Are Regulated
- IVDs are classified into four categories—Class A, B, C, and D—based on their risk level. This classification determines the regulatory requirements, approval process, and compliance obligations for each device.
- To manufacture and market IVD devices in India, companies must obtain the appropriate licenses from CDSCO. This involves submission of detailed technical documentation, clinical performance data, and product labeling in accordance with prescribed standards.
- Manufacturers are also required to comply with key regulatory frameworks, including the Medical Device Rules, Indian Pharmacopoeia standards, and Good Manufacturing Practices (GMP) guidelines.
- CDSCO conducts inspections and ongoing surveillance to ensure adherence to these regulations, maintaining the safety, quality, and effectiveness of IVD devices in the Indian market.
How BlackBows Supports You
Strong Industry Experience
Proven track record of successfully supporting manufacturers and importers with consistent client satisfaction and long-term partnerships.
Ethics, Integrity & Excellence
We operate with the highest professional standards, ensuring transparency, compliance, and dependable advisory at every step.
Expert-Led Team
Our specialists bring deep regulatory knowledge and hands-on experience, ensuring precise execution and high-quality outcomes.
Up-to-Date Regulatory Expertise
We stay aligned with the latest CDSCO regulations and industry updates, ensuring all applications remain fully compliant and error-free.