Important Notice: Please note that the Union Health Ministry in India has recently amended the Drugs and Cosmetics Rules, 1945(DCR) and the appended Schedule Y implementing new regulatory requirements for research conducted in India effective as of January 30, 2013. These amendments and updates have been integrated into the information available on this site; however, further amendments and updates may follow. Please consult with independent Indian regulatory experts and/or legal counsel if contemplating research in India and/or to learn more about these regulatory changes.
Primary Regulatory Agency
Within CDSCO, the CLAA is responsible for oversight of medical devices.
India's Department of Health Research is working to create a Medical Technology Assessment Board which will evaluate new and existing medical technologies.
Clinical Trial Data Requirements
In 2010, CDSCO issued draft guidance entitled "Requirements for Conducting Clinical Trials of Medical Devices in India," which is available here. General requirements for initiating clinical trials of medical devices are outlined by the CDSCO here.
Application must include:
1. Cover letter expressing intent of application (feasibility study, safety and efficacy study, post market study)
2. Form 44 (including relevant required technical data as Appendices I and II)
3. Fee based on the type of study
4. Designation of a Principal Investigator
6. Global regulatory status of the device in other countries (particularly in USA, Australia, Japan, Canada, EU)
7. Investigator's undertakings
8. Ethics committee approval letters
9. Informed consent form
10. Case record form
11. Patient record form
12. Relevant published literature
13. Investigator's brochure
14. Suspected Unexpected Serious Adverse Reaction (SUSAR) information from other participating countries
15. Affidavit from sponsor that the study has not been discontinued in any other country
16. Clinical study report
Pursuant to a July 2014 MoH&FW order, clinical trial procedures for medical devices will be similar to new drugs and vaccines. The order can be found here.
Common Technical Document (CTD) Acceptance
Clinical Trial Costs
Feasibility Study (safety and efficacy): 50,000 rupees.
Pivotal Study (confirmatory): 25,000 rupees.
In-Country Manufacturing Requirements
CDSCO has guidelines for the import and manufacture of medical devices, which are available here.
Precedent (Clinical Trials Approved/Denied in Last 2 Years)
13 clinical trials approved from July 2012 to july 2014.
Product Registration Data Requirements
"Frequently Asked Questions on Registration and Import of Medical Devices in India" outlines requirements and is available here.
Product Registration Timelines
Product Registration Costs
A fee of US$1000 is required with a Form 40 application to register a single imported medical device.
Product Registration Process for Products Approved by SRA/WHO
Imported devices that have prior approval in the US, EU, Canada, Japan or Australia may be sold in India if they submit a technical dossier and specified documents.
Post Registration Pharmacovigilance Requirements
Once a device is marketed the manufacturer must continue submitting periodic safety reports. All AEs must be reported within 10 days. If it is a serious event or death it needs to be reported within 48 hours.
Product Registration Follow-up Requirements
According to "Frequently Asked Questions on Registration and Import of Medical Devices in India," if there is an adverse event, the sponsor is required to report it to CDSCO. Refer to CDSCO's general guidance on pharmacovigilance.
September 24, 2014.