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.
# |
Application form |
Approval form |
Risk class |
Govt. Fees |
CDSCO |
SLA |
|---|---|---|---|---|---|---|
| 1 | MD 1 -Application for grant of Certificate of Registration of a Notified Body | MD 2- Certificate of Registration for a Notified Body under the Medical Devices Rules, 2017 | NA | Rs. 25000 |  |
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| 2 | MD 3- Application for Grant of Licence to Manufacture for Sale and Distribution of Class A or Class B medical device | MD 5- Licence to Manufacture for Sale or for Distribution of Class A or Class B Medical Device. | A & B | Rs-5000 for plant registration Rs-500 for product (per product) |
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| 3 | MD 4- Application for Grant of Loan Licence to Manufacture for Sale or for Distribution of Class A or Class B medical device | MD 6- Loan Licence to Manufacture for Sale or for Distribution of Class A or Class B medical device | A & B | Rs-5000 for plant registration Rs-500 for product (per product) |
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| 4 | MD 7- Application for Grant of Licence to Manufacture for Sale or for Distribution of Class C or Class D | MD 9- Licence to Manufacture for Sale or for Distribution of Class C or Class D | C & D | Rs-50000 for plant registration Rs-1000 for product (per product) |
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| 5 | MD 8- Application for Grant of Loan Licence to Manufacture for Sale or for Distribution of Class C or Class D | MD 10- Loan Licence to Manufacture for Sale or for Distribution of Class C or Class D medical device | C & D | Rs-50000 for plant registration Rs-1000 for product (per product) |
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| 6 | MD 11- Form in which the Audit or Inspection Book shall be maintained | NA | $6000 | |
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| 7 | MD 12- Application for licence to manufacture medical device for purpose of clinical investigations, test, evaluation, examination, demonstration or training | MD 13- Licence to Manufacture Medical Devices for the Purposes of Clinical Investigations or Test or Evaluation or Demonstration or Training | A, B, C, D | Rs.500/- | |
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| 8 | MD 14- Application for issue of import licence to import medical device In Class A (Other than in vitro) | MD 15- Licence to Import Medical Device In Class A (other than in vitro) | A | $1000 for plant $50 for product (per product) |
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| 9 | MD 14- Application for issue of import licence to import medical device In Class B (Other than in vitro) | MD 15- Licence to Import Medical Device In Class B (other than in vitro) | B | $2000 for plant $1000 for product (per product) |
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| 10 | MD 14- Application for issue of import licence to import medical device In Class C or D (Other than in vitro) | MD 15- Licence to Import Medical Device In Class C or D (other than in vitro) | C & D | $3000 for plant $1500 for product (per product) |
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| 11 | MD 14- Application for issue of import licence to import medical device In Class A or B (In vitro) | MD 15- Licence to Import Medical Device In Class A or B (In vitro) | A & B | $1000 for plant $10 for product (per product) |
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| 12 | MD 14- Application for issue of import licence to import medical device In Class C or D (In vitro) | MD 15- Licence to Import Medical Device In Class C or D (In vitro) | C & D | $3000 for plant $500 for product (per product) |
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| 13 | MD 16- Application for Licence to Import Medical Devices for the Purposes of Clinical Investigations or Test or Evaluation or Demonstration or Training | MD 17- Licence to Import Medical Devices for the Purposes of Clinical Investigations or Test or Evaluation or Demonstration or Training | A,B,C,D | $100 | |
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| 14 | MD 18- Application for licence to import investigational medical devices for the purposes by a government hospital or statutory medical institution for the treatment of patients | MD 19- Licence to import investigational medical device by a government hospital or statutory medical institution for the treatment of patients | A,B,C,D | Rs.500/- | |
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| 15 | MD 20- Application for permission to import small quantity of medical devices for personal use | MD 21- Permission to import of small quantity of medical devices for personal use | A,B,C,D | No Fee | |
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| 16 | MD 22- Application for Grant of permission to conduct clinical investigation of an investigational medical device | Form 23- Permission to conduct Clinical Investigation | A,B,C,D | Rs.1,00,000 | |
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| 17 | MD 24- Application for grant of permission to conduct clinical performance evaluation of new in vitro diagnostic medical device | MD 25- Permission to conduct clinical performance evaluation of new in vitro diagnostic medical device | A,B,C,D | Rs.25000/- | |
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| 18 | MD 26- Application for grant of permission to import / manufacture for sale or for distribution of medical device which does not have predicate medical device | MD 27- Permission to import or manufacture for sale or for distribution of medical device which does not have predicate medical device | A,B,C,D | Rs.50000/- | |
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| 19 | MD 28- Application for grant of permission to Import or Manufacture for sale or for distribution of new in vitro diagnostic medical device | MD 29- Permission to Import or Manufacture New In Vitro Diagnostic Medical Device | A,B,C,D | Rs.25000/- | |
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| 20 | MD 39- Application for grant of registration to Medical Device Testing Laboratory for carry out Test or Evaluation of a medical device on behalf of manufacturer | MD 40- Certificate of registration to Medical Device Testing Laboratory for carry out Test or Evaluation of a medical device on behalf of manufacturer | NA | Rs.20000/- | |
