Central Drug Standard Control Organization (CDSCO) is the regulatory authority that regulates Medical Devices in India. It is important to know the medical device approval cost including the CDSCO application fee, CDSCO clinical investigation fee, device registration fee, etc…
Either you are a manufacturer, importer or distributor, knowing this is essential for effective budget planning. Continue to read to know about CDSCO medical device registration cost, Import License fee, Medical Device Manufacturing License cost in India and more.
CDSCO Medical Device Approval: Fee Structure
This is a fee structure breakdown of CDSCO for medical devices.
| CDSCO Submission Type | Standard Fee | Applied to/when |
| Class A Device Registration | ₹3000 | Low risk |
| Class B Device Registration | ₹3000 | Low moderate risk |
| Class C Device Registration | ₹3000 | Moderate high risk |
| Class D Device Registration | ₹3000 | High risk |
| Import License | $1000- $3000 | Per site & Type of device class |
| Clinical Investigation Application | ₹1,00,000 | If required |
| Manufacturing License | ₹5000 – ₹50,000 | Per Site & Type of device class |
| Retention Fee | ₹3000 – ₹2,61,816 | Every 5 years |
Also Read: Medical Devices Regulations In India
CDSCO Medical Device Approval Cost In India
To conduct any regulatory activity concerning the approval of medical devices an application submission has to be made to CDSCO. An application fee also must be paid. The fee depends on the class of the device and the type of application (Registration, license for manufacturing, importing…) made.
Let’s take a look at some of the types of application submission and corresponding fee related to them.
Registration Fees
All the medical devices must be registered under CDSCO. This provides a registration number. The registration fees for all classes of devices are the same.
Manufacturing License Fees
Any person who wishes to manufacture Class A or Class B including IVD must submit an application for grant of license to manufacture for sale or distribution to the State Licensing Authority (SLA). In the case of Class C or Class D devices, license to manufacture for sale or for distribution, an application must be submitted to the Central Licensing Authority (CLA). Both the applications are submitted via an online identified portal (SUGAM portal) of the Central Government in respective forms.
| Manufacturing License | Per Site/ Each distinct device | Fee to be Paid |
Class A (Other than non-sterile and non-measuring) | Per Site | Rs. 5000 |
| Each distinct device | Rs. 500 | |
Class B | Per Site | Rs. 5000 |
| Each distinct device | Rs. 500 | |
Class C | Per Site | Rs. 50,000 |
| Each distinct device | Rs. 1000 | |
Class D | Per Site | Rs. 50,000 |
| Each distinct device | Rs. 1000 |
Class A (Non-sterile and non-measuring) devices are exempted from the licensing regime but require registration and self-certification of the product in compliance with essential performance checklist of safety and performance of such devices.
Also Read: Types of Medical Device Approval Licenses by CDSCO
CDSCO Import license Fee
An authorized agent who holds a manufacturing license or wholesale license for sale or distribution as per Medical Device Regulation 2017, should apply for an application for the grant of license for import of medical devices. It is applied via an online identified portal by the central Govt. (SUGAM portal) in respective form. Unlike the manufacturing license, the import license is applied to the Central Licensing Authority for all medical devices. Any changes in the documents submitted prior to or at the time of application must be informed to CLA in writing.
| Import License | Per Site/ Each distinct device | Fee to be Paid |
Class A (Other than non-sterile and non-measuring) | Per Site | $1,000 |
| Each distinct device | $ 50 | |
Class B | Per Site | $2,000 |
| Each distinct device | $ 1000 | |
Class C | Per Site | $3,000 |
| Each distinct device | $1,500 | |
Class D | Per Site | $ 3000 |
| Each distinct device | $1,500 | |
| Fee to import investigational medical device by the government hospital or statutory medical institution for the purpose of patient treatment for each distinct medical device | Each distinct device | Rs 500 |
As stated earlier, Class A (non-sterile and non-measuring) devices are exempted from licensing regime but require self-certification.
CDSCO Clinical Investigation Fee
As per MDR 2017, the clinical trials are conducted in 2 phases for Investigational Medical Devices. Pilot Clinical Investigation & Pivotal Clinical Investigation.
- Pilot Clinical Investigation – Conducted first in human participants
- Pivotal Clinical Investigation – A Confirmatory study conducted to generate evidence in support of Investigational Medical Device.
The Investigational Medical Devices developed in India, the clinical trials must be conducted in India from pilot Clinical Investigation (First in human study) and the generated data must be submitted. In case of Investigational Medical Devices manufactured and studied out of India, Pilot Clinical Investigation or data of relevant clinical trials must be submitted while submitting the application.
After submitting the data generated out of India to the CLA, permission to repeat the pilot study or conduct Pivotal Clinical Investigation. It is required to conduct Pivotal Clinical Investigation in India before permission to market the medical device in India except for Investigational Medical Devices under class A.
The cost breakdown is given below:
| Clinical Investigation | Associated Fee |
| Permission for pilot investigation conductance | Rs. 1,00,000 |
| Permission for pivotal investigation conductance | Rs. 1,00,000 |
CDSCO Medical Device Renewal & Post-Approval Fees
After the approval of a medical device license, it has a validity and after the validity date it tends to expire. The license can be renewed by CDSCO from time to time before it gets expired. The import license, manufacturing license and the registration certificate granted by CDSCO under MDR 2017 is valid to perpetuity until suspension/cancellation given that a retention fee must be paid every 5 years.
| License/ Registration | Retention Fee |
| Registration Certificate for the sale of medical devices | Rs. 3000 |
Retention fee for manufacturing license
| Manufacturing License | Per Site/ Each distinct device | Retention Fee |
Class A (Other than non-sterile and non-measuring) and Class B devices | Per Site | Rs. 5000 |
| Each distinct device | Rs. 500 | |
Class C and Class D devices | Per Site | Rs 50,000 |
| Each distinct device | Rs 1000 |
Retention fee for import license
| Import License | Per Overseas Site/ Each distinct device | Retention Fee |
Class A (Other than non-sterile and non-measuring) | Per Overseas Site | $1,000 |
| Each distinct device | $ 50 | |
Class B | Per Overseas Site | $2,000 |
| Each distinct device | $ 1000 | |
Class C | Per Overseas Site | $3,000 |
| Each distinct device | $1,500 | |
Class D | Per Overseas Site | $ 3000 |
| Each distinct device | $1,500 |
Small Business Concessions And Fee Waivers by CDSCO
Although the MDR 2017 doesn’t speak about any specific fee waivers or concession for small business owners, Schedule Eight has listed conditions for medical devices that are exempt from certain provisions of MDR 2017. This can lead to Medical Device Approval Cost waivers or reduced regulatory fees.
CDSCO Additional Costs To Consider For Devices Approval
As stated earlier, a retention fee must be paid every 5 years to maintain the license validity. If the license holder doesn’t pay the retention fee before the due date mentioned, a late fee along with the retention fee must be paid for every month or part of the month delayed. The late fee is calculated at a 2% rate of the original retention fee.
Apart from this there are inspection fees, test license fee for manufacture for clinical investigation, test, examine, evaluate, demonstrate or training for each distinct medical device, export certificate fee, registration of medical device testing laboratory, Authorized Agent (for foreign manufacturers), etc.
Medical Devices & Important Forms Used
Application for each type of license, registration or any other activity is made in specific forms. The common types of forms for medical devices are listed below:
| Form | Title |
| Form MD-3 | Application for grant of license for Class A & Class B device manufacture for sale and distribution. |
| Form MD-5 | License to Manufacture for Sale or for the Distribution of Class A or Class B Medical Devices. |
| Form MD-7 | Application for grant of license for Class C & Class D device manufacture for sale and distribution. |
| Form MD-9 | License to Manufacture for Sale or Distribution of Class C or Class D Medical Device. |
| Form MD-14 | Application to issue import license for the import of medical devices. |
| Form MD-15 | License to import medical device |
| Form MD-22 | Application for the grant of permission to conduct clinical investigation of an investigational medical device. |
| Form MD-23 | Permission to conduct clinical investigation |
| Form MD-41 | Application for grant of registration certificate to sell, stock, exhibit or offer for sale or distribute a medical device including IVD. |
| Form MD-42 | Registration certificate to sell, stock, exhibit or offer for sale or distribute a medical device including IVD. |
Now that we know about the forms to be used, let’s take a look at the approval process of application renewal via SUGAM portal for medical devices.
Conclusion
Getting a medical device approved in India isn’t always easy—especially if you’re dealing with CDSCO for the first time. The rules can be tricky, and without a clear plan, you might hit delays or extra costs. But here’s the thing: if you know where to look, there are ways to speed things up and even cut down approval expenses.
Artixio has regional experts with several years of expertise in the medical device industry all around the world. Our regional professional will help you with the CDSCO medical device approval and expedite the process by guiding you through the complex regulations. Reach out to us at info@artixio.com
FAQ’s
Q. Are there any separate fees for importing Class B devices into India?
A. Yes, there are separate fees for importing each class of medical device to India. For Class B medical devices, it costs $ 2000 per site and $ 1000 for each distinct Class B medical device.
Q. Do CDSCO fees differ for domestic and international manufacturers?
A. Yes, the fee for domestic and international manufacturers of medical devices are different. Domestic manufacturers have to apply for Manufacturing license whereas international manufacturers have to apply for import license. Under CDSCO, the Manufacturing License fee and the Import License fee are different.
Q. Is there a clinical investigation fee for all medical devices in India?
A. Yes, in order to conduct clinical investigation of medical devices in India, permission is to be applied for and granted. A fee must be paid to gain permission to conduct clinical investigations in India.
Q. How long is the CDSCO approval valid?
A. CDSCO approval of licenses/registrations are valid to perpetuity until a retention fee is paid every 5 years.
Q. Are there penalties for late renewal or non-compliance?
A. Yes, there are penalties for late renewal (retention fee). A late fee along with the original retention fee must be paid. The late fee is calculated at a 2% rate (of the retention fee) for every delayed month. Apart from this non-compliance with the requirements can lead to fines, suspension or cancellation of the license of the device can occur.
