The medical devices industry is one of the most crucial sectors within healthcare, driven by advancing technologies and rapid innovations. As one of the fastest-growing industries, medical devices are at the forefront of healthcare transformation. With these rapid changes, regulatory frameworks are becoming increasingly dynamic, evolving to keep pace with the industry’s advancements. Regulatory compliance is also becoming more stringent, as global regulators demand higher standards and more detailed data from manufacturers.
The industry is shifting from a reactive to a proactive approach, spanning all aspects from research and development (R&D) to distribution. Medical device manufacturers are now required to submit more comprehensive data about their processes and products than ever before. As a result, having a robust global regulatory strategy is crucial for the rapid commercialization of medical devices in today’s competitive market.
At Transparon, we understand the complexities of these evolving regulations and offer strategic guidance to navigate the regulatory landscape. Our services include support for India Registrations, CE Marking, ISO 13485 implementation, and Clinical Investigations, ensuring compliance with various regulatory authorities.
Overview of various licenses, class and govt. fees
# |
application form |
approval form |
risk class |
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/- |
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