Diagnostic Kits Regulatory
At Barrocyte Consultants, we help manufacturers overcome the barriers in preparing strong regulatory strategies and unambiguous dossiers for filing applications for various drug products approval. Experts from our team represent our clients at the SEC meetings to obtain unanimous approvals and permissions. Our constant guidance, thorough follow up and other services like clinical trial management, medical writing, etc. enable our client to obtain successful approval/permission smoothly and apply for licenses
Diagnostic Kits Regulatory Service
NEW IN-VITRO DIAGNOSTIC DEVICE – INDIA'S FIRST-TIME REGULATIONS
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 for their manufacture or Import in India.
CLASSIFICATION OF DIAGNOSTIC KITS
Based on New Medical Rules, the classification of the diagnostic kits takes into consideration factors like the involved risk, medical condition being diagnosed, self-testing or near patient testing. Diagnostic kits used for serious medical conditions like HIV or Cancer are classified as high-risk devices and hence placed under Class D. Other simple kits like glucose testing strips and sphygmomanometers are placed under Class A & B.
Forms for Application
| Applicant | Risk/Class | Type of Licence | Forms |
|---|---|---|---|
| Importer | A, B, C, D | Importer License | Application: MD-14 Permission: MD-15 |
| Manufacturer | A, B | Manufacturing License | Application: MD-3 Permission: MD-5 |
| Loan License | Application: MD-4 Permission: MD-6 | ||
| C, D | Manufacturing License | Application: MD-7 Permission: MD-9 | |
| Loan License | Application: MD-8 Permission: MD-10 | ||
| Importer | A, B, C, D | Clinical Performance Evaluation | Application: MD-24 Permission: MD-25 |
| Manufacturer | A, B, C, D | Clinical Performance Evaluation | Application: MD-24 Permission: MD-25 |
| Importer (New In-Vitro Device) | A, B, C, D | Import License | Application: MD-28 Permission: MD-29 |
| Manufacturer (New In-Vitro Device) | A, B, C, D | Manufacturing License | Application: MD-28 Permission: MD-29 |
For Importers
India’s rapid economic growth has led to a surge in demand for medical equipment. The new medical rules classify all diagnostic kits, including previously unclassified ones. The import license process is now a simplified single-step procedure, allowing multiple importers for a single kit, though each must file a separate application.
Import License Process
Classification of Medical
Documents as per Checklist
Application Filing
Import LicenseDevice
How To Apply?
As per the Medical Device Rule 2017, the process of approval from CDSCO is as follows:
Evaluation of the product, if it requires registration under MDR 2017 (Regulated/Non-Regulated).
If requires registration, evaluation of classification (Class A, B, C, D) based on the product risk category.
Mandatory document requirement: sharing the list and reviewing its adequacy.
Appoint an authorized agent.
Online generation of application.
Approval/confirmation of draft application by the authorized agent and submission.
Follow-up with the regulatory authority and query management if any.
Final approval.
WHY CHOOSE US
Medical Device Import License Fees
Important Documents
Wholesale Licence
Power of Attorney
Free Sale Certificate from GHTF
Device Master File
Site Master File
Timeline to Obtain Form MD-15 from CDSCO
The Government Timeline for Import License Form 15 for in-vitro Diagnostic kits is 6-9 months.
Diagnostic Kits Manufacturing Service
Diagnostic Kits Manufacturing
New regulations have been introduced for the manufacturing of medical devices in India. Manufacturers of Class A and B devices must apply to the State Licensing Authority, while those producing Class C and D devices are regulated by the Central Licensing Authority. These classifications are based on the level of risk associated with each device. Additionally, CDSCO has outlined specific application fees for each category to streamline the licensing process.
Classification of Diagnostic Kits
Manufacturing License for IVD Kits from SLA/CLAA
Any company planning to manufacture Class A and B diagnostic devices must obtain permission from the State FDA. These devices are classified as low to moderate risk, making the application process simpler and less stringent. Manufacturers seeking a loan to manufacture diagnostic kits must first obtain a loan license from the State Licensing Authority. Barrocyte Consultants assist with filing manufacturing and/or loan licenses for Class A and B diagnostic kits. The Manufacturing License for...
Class C and D diagnostic kits involve a higher risk, making their license application process more stringent. Permission to manufacture these devices is obtained from the Central Licensing Authority using Form MD-9. Manufacturers seeking a loan for manufacturing must first obtain a loan license. The Manufacturing License for Class C and D IVDs is regulated by the Central Licensing Authority. The application for the Manufacturing License is filed in Form MD-7, and for a loan license, it’s f...
Diagnostic kits can be manufactured in small quantities for testing, clinical investigation, demonstration, or training purposes. A test license must be obtained from the Central Licensing Authority. The application is filed using Form MD-12, and the permission is granted in Form MD-13. New diagnostic kits, both notified and non-notified, require a test license from CDSCO for import and market in India. The test license allows manufacturing In Vitro diagnostic kits for evaluation with the ...