Permission to conduct clinical investigation in India - MD22 & MD-23
CliniExperts works as an expert solution provider for regulatory processes in India. It provides 360-degree regulatory support for both domestic and foreign markets. The qualified team at CliniExperts is available to assist manufacturers and importers who wish to obtain permission to conduct a clinical investigation for an investigational medical device (MDs) in India with hassle-free and minimal paperwork.
Permission to conduct clinical investigation – Overview
The Central Licensing Authority (CLA) and Central Drugs Standard Control Organisation (CDSCO) are the regulatory bodies that supervise all medical device permissions to conduct clinical investigations. The timeline for receiving the permission from them to conduct a clinical investigation of an investigational medical device (MD) is around 1 to 2 months.
The manufacturers and importers who wish to carry out a clinical investigation of an investigational medical device should obtain permission from the CLA, which can be done through an online application process.
The manufacturers and importers can apply for this service through the following process:
- The applicant (manufacturer and importer) must apply for permission to conduct an investigation for an investigational Medical Device to the CLA.
- This can be done by submitting an application through an identified online Medical Device portal of the Ministry of Health and Family Welfare in Form MD-22.
- The permission obtained to conduct the clinical investigations for the investigational Medical Device will be in Form MD-23.
Who Can Apply?
Any manufacturer or importer who wants to do a clinical investigation of an investigational Medical Device may apply to the CLA through this service.
How To Apply?
The Applicant must follow the following process:
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Step 1: The application for grant of permission to conduct a clinical investigation of an investigational Medical Device can be made in Form MD-22
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Step 2: The application should address the Central Licensing Authority of India and the Central Drugs Standard and Control Organisation.
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Step 3: The application should be submitted with the required documents and the application fees on the SUGAM portal.
Validity
The license will not expire once the permission has been obtained to conduct the clinical investigations for the medical device unless there is a suspension or cancellation from the authorities.
Fee Involved
The Government consider specific fees for this service of about 1,00,00 INR for both pilot clinical investigation and pivotal clinical investigation permission.Important Documents
The essential documents required in this service are:
- Clinical Investigation Plan
- Design input and output documents
- Mechanical and electrical tests (if any)
- Ethics committee approval letter
- Biocompatibility test reports
- Reliability tests
- IFU and Labels
Timeline to get
MD-23
from Central Drugs Standard Control Organisation
1 to 2
MONTHSEssential Tips
The following three essential tips will benefit during the application process:
- While conducting the clinical investigation of the investigational medical devices, the Ethics Committee approval letter is necessary.
- During the application process, the biocompatibility test reports are necessary to carry out the clinical investigation.
- The Clinical Investigation Plan is also required for the application. Problems can be faced during the application process. To avoid them, applicants can ensure the following:
- First, the clinical investigation plan must be approved by the registered Ethics Committee and only then the clinical investigation should be initiated.
- The enrolment of the first participant within 1 year of permission is required before initiating the clinical investigation. Therefore, it should be done within one year from the date of grant of permission. Failing recruitment within 1 year of permission, prior approval from the CLA will be required again to initiate the clinical investigation.
- The applicant needs to provide complete medical management or compensation according to the MDR, 2017, in case there is any injury or death of a subject during the clinical investigation.
Expert Advise
CliniExperts provides certain advice to their clients -
Applicant should possess a letter of approval from the Ethics Committee as an essential document before applying for permission to conduct clinical investigations of an investigational Medical Device.
The clinical investigations study must be performed in a CDSCO-approved laboratory.
The clinical investigation should be registered with the Clinical Trial Registry of India before enrolling the first participant in Clinical Investigation
Related Services
Frequently Asked Questions
Will the local clinical investigation or evaluation requirements be waived off for devices already on the market and notified?
No. The clinical investigation or evaluation will not be waived off for devices that are already on the market and notified later. The medical devices will be evaluated on a case-by-case basis, which will be based on their intended use and the data available to verify their safety and efficacy. The SEC may also be consulted on this issue.
Will the clinical investigation in India, be waived off for all classes if the product is manufactured in other countries than listed in Rules 36 sub-rule (3)?
No. According to the Rules 36 sub-rule (4), any medical device that is imported from other countries than those listed in Rules 36 sub-rule (3), the license for Class C and D medical devices will be granted after the complete safety and effectiveness is well established through a clinical investigation in India which is specified under the provision of Chapter VII of these rules. In the case of Class A and B devices, the license will be granted only after its safety and performance check get established through safety and performance data. It can also be done through clinical investigation, or a free sale certificate from the country of origin is furnished.
Will the clinical trial be waived in the event of CE marking to import a medical device without a predicate?
No. If the regulatory authorities approve the investigational Medical Devices in the United Kingdom, the United States of America, Australia, Canada, or Japan, the clinical investigation results in India might not be required. It is essential that these approved medical devices should have been marketed for at least two years in said country and that the Central Licensing Authority needs to be satisfied with the data on the safety of the device, performance and pharmacovigilance.
Do each applicant need to obtain investigational device approval again for each new medical device, or does the next importer get the Import license once the first importer receives approval?
Yes. Every applicant must obtain a separate investigational device approval for each new Medical Device.
What is the timeline allotted to carry out a clinical investigation after the permission. If not conducted within the said time, will it get cancelled?
Yes, it is necessary to initiate the clinical investigation by enrolling the first participant within one year from the date of grant of permission. Otherwise, the permission from the Central Licensing Authority gets cancelled and required to apply again to initiate a clinical investigation.