In-Vitro Diagnostic Regulatory Services
Comprehensive regulatory solutions for diagnostic kits and in-vitro devices in India. End-to-end guidance for foreign importers, authorized agent representation, and domestic manufacturing licensing across all risk categories.
In-Vitro Diagnostic Regulatory Services in India
Diagnostic Kits play an important role in Medical science and are the base of almost every test, surgery, or medical experiment. Pertaining to their importance and effectiveness in the medical field, the Government of India has promulgated proper rules and guidelines for diagnostic kits in the New Medical Devices Rules, 2017, w.e.f. 1st January, 2018. All diagnostic kits, whether used In-vitro or In-vivo, are now regulated under the New Medical Device Rules, 2017. Diagnostic kits either manufactured in India or imported from foreign countries are required to obtain a license for manufacturing, sale, and use in the Indian market from the designated Licensing Authority depending upon their classification.
Following the New Medical Device Rules, 2017, all in-vitro diagnostic devices and kits have been classified into four basic categories, the licenses for which are allotted by respective Central and State authorities. The categorization is based upon the complexity and risk involved with using the diagnostic kit.
New In-Vitro Diagnostic Device – First time in India
Any In-Vitro Diagnostic Device which does not have a predicate or similar device in the Indian market is considered to be a New In-Vitro Diagnostic Device. Such devices need to gain approval from the Central Licensing Authority (CDSCO) for their manufacture or import in India through clinical performance evaluation and special statutory review.
Classification of Diagnostic Kits in India
Based on the New Medical Device Rules, 2017, the classification of in-vitro diagnostic kits takes into consideration factors like the involved risk, the medical condition being diagnosed, self-testing, or near-patient testing. In-vitro diagnostic kits are classified into four categories:
Reagents & Instruments
Class A IVD devices are considered to have low risk and minimal invasiveness. Examples include reagents, solutions, buffer salts, wash solutions, specimen receptacles, and laboratory instruments used for testing.
Rapid & Self-Testing
Class B IVD devices are considered to have low-to-moderate risk with minimal invasiveness. Examples include pregnancy test kits, blood glucose test strips, fertility tests, cholesterol tests, and urine analysis test strips.
Infectious & Oncology Assays
Class C IVDs detect infectious agents with the potential to cause severe disability or health impact. Examples include HIV diagnostic testing kits, hepatitis testing kits, cancer diagnostic kits (PSA, CA-125), and STI panels.
Blood Screening & Contagion
Class D IVD devices are considered to have the highest risk and require the most extensive regulation. Detects life-threatening or highly contagious infectious diseases, blood donor screening (HIV, HBV, HCV), and companion diagnostics.
Overview of Forms for Application
CDSCO has provided various forms to be used while filing the application for permission to import or manufacture diagnostic kits. The following tables detail the specific statutory forms required for each applicant category:
Existing Diagnostic Devices
Standard Pathway| Applicant | Risk / Class | Type of License | Forms |
|---|---|---|---|
| Importer | A, B, C, D | Importer License | Application: MD-14|Permission: MD-15 |
| Manufacturer | A, B | Manufacturing License (SLA) | Application: MD-3|Permission: MD-5 |
| A, B | Loan License (SLA) | Application: MD-4|Permission: MD-6 | |
| Manufacturer | C, D | Manufacturing License (CLA) | Application: MD-7|Permission: MD-9 |
| C, D | Loan License (CLA) | Application: MD-8|Permission: MD-10 | |
| Importer / Mfg | A, B, C, D | Clinical Performance Evaluation | Application: MD-24|Permission: MD-25 |
New In-Vitro Diagnostic Devices (First Time in India)
New Device Approval| Applicant | Risk / Class | Type of License / Authorization | Forms |
|---|---|---|---|
| Importer | A, B, C, D | Clinical Performance Evaluation | Application: MD-24|Permission: MD-25 |
| A, B, C, D | Import License (New In-Vitro Device) | Application: MD-28|Permission: MD-29 | |
| A, B, C, D | Test License for Import | Application: MD-16|Permission: MD-17 | |
| Manufacturer | A, B, C, D | Clinical Performance Evaluation | Application: MD-24|Permission: MD-25 |
| A, B, C, D | Manufacturing License (New In-Vitro Device) | Application: MD-28|Permission: MD-29 | |
| A, B, C, D | Test License for Manufacturing | Application: MD-12|Permission: MD-13 |
For Importers
India has developed at a staggering rate as an economy. Hence the demand for medical care equipment has skyrocketed in recent years. The new medical rules have classified all existing diagnostic kits, including those which were earlier not classified. Filing an application for obtaining an import license is a simple single-step process now. The process has been simplified to expedite the process and ensure proper availability of diagnostic kits in the country. The New Medical Device Rules allow multiple importers of a single diagnostic kit, which was forbidden earlier. Although, each importer has to file a separate application for each diagnostic kit being imported.
Import License Process
Classification of Medical Devices
Authorized Agent / Registration Holder Support
Application Filing (Form MD-14)
Import License (Form MD-15)
Authorized Agent / Registration Holder
All the applications for the import of diagnostic kits will be filed by an Authorized Agent only. A foreign manufacturer cannot file an application directly with CDSCO. An Authorized Agent means a person including any firm or organization who has been appointed by an overseas manufacturer through a power of attorney to undertake import of diagnostic kits in India.
We at NKB Regovanta hold a valid Wholesale License (Form 20B and 21B) enabling us to act as an Authorized Agent for our clients, which helps reduce the time required for a foreign manufacturer to set up their office in India and expedites the launching of the product.
For Manufacturer
New Medical Device Rules, 2017 have defined distinct provisions to obtain permission for the manufacturing of diagnostic kits in India. Different diagnostic kits have been classified under different categories based upon their use, complexity, and the risk involved. Applications for Class A and Class B diagnostic kits are reviewed and granted permission by the State Licensing Authorities. Whereas applications for Class C and Class D medical devices are reviewed and granted license by the Central Licensing Authority. This difference is due to the depth and scale of review involved for different classes of diagnostic kits. CDSCO has also defined different fees for different classes of diagnostic kits.
Comprehensive Manufacturing & Facility Compliance
Obtaining the required licenses, certifications, and approvals for these devices involves detailed technical compilation. More than 40 specific documents covering 12 different factors must be filed for the Plant Master File (PMF), alongside the Device Master File (DMF), SUGAM portal registration, ISO 13485 certification, and Clinical Performance Evaluation data.
Permission to Manufacture or Loan License for Class A & B Diagnostic Kits in India from State FDA (Form MD-5 and Form MD-6)
Any company planning to manufacture Class A and B diagnostic devices must obtain permission to manufacture from the State FDA. Since Class A and B devices are classified as low to moderate risk, the application review process for them is streamlined. Any manufacturer who needs a loan to manufacture diagnostic kits must first obtain a loan license from the State Licensing Authority. NKB Regovanta helps you file manufacturing and loan licenses for Class A and B diagnostic kits smoothly and efficiently.
New In-Vitro Diagnostic – First Time in India
New In-Vitro Diagnostic Devices are devices that have not been approved for manufacturing or importing by the Central Licensing Authority, or whose similar or predicate device is not available in India. Such diagnostic kits need to undergo clinical investigations to prove their safety and effectiveness. This Clinical Performance Evaluation is conducted on specimens collected on voluntary human participants. Once the clinical performance evaluation has been completed, a report describing the results of the investigation is generated. An application for the import or manufacture of the new In-Vitro Device is filed with the Central Licensing Authority along with this performance evaluation report. After proper evaluation of the findings, permission is granted by the CLA to import or manufacture the diagnostic kit in India.
Permission to Conduct Clinical Performance Evaluation for New In-Vitro Diagnostic (Form MD-24, Form MD-25)
Any new in-vitro diagnostic kit has to undergo a clinical performance evaluation. The application to obtain permission for this evaluation for any class of medical device has to be filed at the Central Licensing Authority using Form MD-24 (grant in Form MD-25). Preparing and filing the application in the right format is essential to ensure positive approval. NKB Regovanta has trained professionals to help you prepare the application and attach findings of the Clinical Performance Report in the proper statutory format.
CDSCO – How it Governs IVD Regulatory Affairs
The CDSCO is responsible for regulating the manufacture, import, and sale of IVD devices in India. It has established a regulatory framework requiring IVD manufacturers and importers to comply with requirements related to registration, classification, clinical performance evaluation, labeling, adverse event reporting, and post-market surveillance.
Manufacturers and brand owners must follow the regulations to ensure that their products are safe and effective for use in India. CDSCO’s role is to enforce the regulations, monitor the quality and safety of IVD devices, and ensure patient safety across the nation.
Why Choose NKB Regovanta?
- End-to-End Regulatory Management: Complete assistance from classification and testing to license grant.
- Emphasis on Ethics & Zero-Defect Filings: High-precision technical dossiers ensuring expedited review.
- Talented Technical Team: Dedicated regulatory specialists with deep experience in IVD assays and MDR 2017.
- Up-to-Date Regulatory Intelligence: Keeping your operations compliant with the latest CDSCO gazette notifications.
Consult Our CDSCO IVD Regulatory Desk
Receive a detailed classification review, statutory fee estimate, and custom roadmap for your diagnostic products.