After consultations with stakeholders, India’s Central Drugs Standard Control Organization (CDSCO), a federal government body, released an updated version of its draft rules for medical devices, including fees payable by the industry.
The fees schedule related medical devices is based on 3 categories – A (low risk), B&C (low Moderate to high moderate) and D (high risk). However, it still has not divulged the fee amounts that notified bodies can charge for their services; which, under the draft rules, are to be set by the federal government, reports Regulatory Affairs Professionals Society.
The prices are just the government fees and assistance from in-country consultants and advisors add substantially more for the registration process. Most companies, including long-standing Indian entities use third party experts for the regulatory filing process.
| Fees Under Draft Medical Device Rule, 2016 | ||
| Section | Fee | Amount |
| 12(2) | Registration of notified body | $750 |
| 15(4) | Manufacturing license of Class A medical device for one site | $75 |
| 15(5) | Manufacturing license of Class B medical device for one site | $75 |
| 15(5) | Manufacturing license of Class C or Class D medical device | $750 for one site; $15 for each distinct device |
| 15(5) | Manufacturing license of Class C or Class D along with Class A or Class B medical device | $750 for one site; $15 for each distinct Class C or Class D device; $3 for each distinct Class A or Class B device |
| 16(1) | Loan license to manufacture of Class A or Class B medical device for one site | $75 |
| 16(2) | Loan license to manufacture of Class C or Class D medical devices | $750 for one site; $15 for each distinct device |
| 24(1) | Manufacturing license or loan license retention fee of Class A or Class B or Class C or Class D | $750 |
| 27(1) | Test license to manufacture for clinical investigations, test, evaluation, examination, demonstrating or training | $7.50 |
| 30(3) | Import license for Class A medical device | $1,000 for one site; $50 for each distinct device |
| 30(3) | Import license for Class B medical device | $1,000 for one site; $50 for each distinct device |
| 30(3) | Import license for Class C and Class D medical device | $3,000 for one site; $1,500 for each distinct medical device |
| 30(7) | License is defaced, damaged or lost | $300 |
| 31 | Inspection of the overseas manufacturing site | $6,000 |
| 33(1) | Import license retention fee of Class A or Class B or Class C or Class D | $3,000 |
| 36(3) | Import license for test, evaluation or demonstration or training | $7.50 for each distinct device |
| 37(1) | Import of investigational medical device by Government hospital or statutory medical institution for treatment of patient | $7.50 for each distinct device |
| 45(2)(a) | Permission to conduct pilot clinical investigation | $1500 |
| 45(2)(b) | Permission to conduct pivotal clinical investigation | $1500 |
| 52(2) | Permission to conduct clinical performance evaluation | $375 |
| 57(1) | Permission to import or manufacture an investigational medical device | $750 |
| 58(1) | Permission to import or manufacture new in vitro diagnostic medical device | $375 |
Last updated: December 26th, 2025
