Conduct clinical trials for medical device and in-vitro diagnostics for launch in India

CliniExperts efficiently support the sponsor to launch their medical device and In-vitro diagnostic with reduced time in Indian market.

We provide full spectrum for services to conduct Clinical Investigation for medical devices and Clinical Performance Evaluation studies for In-vitro diagnostic in India.

Clinical Investigation for Medical Devices

A Clinical Investigation is a systematic investigation or study in human subjects, undertaken to assess the safety and/or performance of a medical device.

Primarily required for risky medical devices (Class B, Class C and Class D) without predicates but may also be required for Class A medical devices.

Medical Devices which are new and are not approved by countries like USA, UK, EU, Japan, Australia and Canada,may also require Clinical investigation in India.

Types of Clinical Investigation Studies as per
the new Medical Device Regulations, 2017:

Pilot clinical investigation

These are clinical investigations on investigational medical devices and are carried out for the first time in human participants.

Pivotal clinical investigation

Pivotal clinical investigation on an investigational medical device is made on the basis of data emerged from pilot clinical investigation

Clinical Performance Evaluation for In-vitro diagnostic medical device

The Clinical Performance Evaluation means the systematic performance study of a new in vitro diagnostic medical device on specimens collected from human participants to assess its performance (whether it is suitable for the purpose(s) and the population(s) for which it is intended).

Required for risky IVD (Class B, Class C and Class D)without predicates and may also be required for Class A IVD's.

The IVD's that mandatorily require Clinical Performance
Evaluation includes but not limited to

Process Involved

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Submit the application dossier to CDSCO and Ethics Committee

Attend an in-person meeting with SEC at CDSCO

Obtain approval from CDSCO as per Medical Device Rule 2017

Site addition/ deletion related notification; as applicable

Submitting annual status reports to Central licensing Authority (CLA)

Periodic Safety Update Report (PSUR) data submission for two years post approval

Compile clinical performance evaluation report/ clinical investigation report application dossier

Review by the Subject Expert Committee (SEC)

Receive SEC recommendations

Registration on CTRI before enrolling the first participant

Major protocol amendments; as applicable

After site closeout- Final CSR submission

Submit the application dossier to CDSCO and Ethics Committee

Attend an in-person meeting with SEC at CDSCO

Obtain approval from CDSCO as per Medical Device Rule 2017

Compile clinical performance evaluation report/ clinical investigation report application dossier

Review by the Subject Expert Committee (SEC)

Receive SEC recommendations

Site addition/ deletion related notification; as applicable

Submitting annual status reports to Central licensing Authority (CLA)

Periodic Safety Update Report (PSUR) data submission for two years post approval

Registration on CTRI before enrolling the first participant

Major protocol amendments; as applicable

After site closeout- Final CSR submission

Submit the application dossier to CDSCO and Ethics Committee

Attend an in-person meeting with SEC at CDSCO

Compile clinical performance evaluation report/ clinical investigation report application dossier

Review by the Subject Expert Committee (SEC)

Obtain approval from CDSCO as per Medical Device Rule 2017

Site addition/ deletion related notification; as applicable

Receive SEC recommendations

Registration on CTRI before enrolling the first participant

Submitting annual status reports to Central licensing Authority (CLA)

Periodic Safety Update Report (PSUR) data submission for two years post approval

Major protocol amendments; as applicable

After site closeout- Final CSR submission

Submit the application dossier to CDSCO and Ethics Committee

Medical Step 1

Review by the Subject Expert Committee (SEC)

Compile clinical performance evaluation report/ clinical investigation report application dossier

Medical Step 2

Attend an in-person meeting with SEC at CDSCO

Obtain approval from CDSCO as per Medical Device Rule 2017

Medical Step 3

Registration on CTRI before enrolling the first participant

/

Site addition/ deletion related notification; as applicable

Medical Step 4

Receive SEC recommendations

Submitting annual status reports to Central licensing Authority (CLA)

Medical Step 5

Major protocol amendments; as applicable

Periodic Safety Update Report (PSUR) data submission for two years post approval

Medical Step 6

After site closeout- Final CSR submission

Frequently Asked Questions

Which class of medical devices require clinical investigation in India?

Clinical investigation in India are typically required for risky medical devices (Class B, Class C and Class D) without predicates and may also be required for Class A medical devices.

FORM MD-24 is an application for grant of permission to conduct, clinical performance evaluation of new in vitro diagnostic medical device.

The clinical performance evaluation shall be initiated within a period of one year from the date of grant of permission.

Every person, sponsor, clinical research organisation, any other organisation or investigator conducting a clinical investigation or his agent holding a permission shall maintain the related data, record, registers and other documents for a period of seven years after completion of such investigation and shall furnish such information as may be required by the Central Licensing Authority or any other officer authorized by it in this behalf.

“Clinical investigation” means the systematic study of an investigational medical device in or on human participants to assess its safety, performance or effectiveness.

Form MD-22 is an application for grant of permission to conduct clinical investigation for investigational medical device.

A “clinical investigation plan” means a document which contains the information about the rationale, aims and objective, design and the proposed analysis, conduct, methodology including performance, management, adverse event, withdrawal and statistical consideration and record keeping pertaining to clinical investigation.

Pilot clinical investigation is defined as those clinical investigations which are used to acquire specific essential information about a device before beginning the pivotal clinical investigation. Pilot clinical investigation is exploratory study which may be conducted in a few numbers of patients with the disease or condition being studied before moving to large population and scope that give insight into the performance and safety of a device but cannot provide definitive support for specific mechanistic or therapeutic claims. The pivotal clinical investigation is a definitive study in which evidence is gathered to support the safety and effectiveness evaluation of the medical device for its intended use. Pivotal clinical investigation is confirmatory study that may be conducted in large number of patients with disease or condition being studied and scope to provide the effectiveness and adverse effects.

The Central Licensing Authority, if satisfied, may grant permission to conduct clinical investigation for an investigational medical device in Form MD-23.

Medical devices are classified as Low risk - Class A; Low moderate risk- Class B; Moderate high risk- Class C; High risk- Class D.

An investigational medical device in relation to a medical device, other than in vitro diagnostic medical device, means a medical device specified (i) which does not have its predicate device (ii) which is licensed under Manufacturing/Loan License/Import License and claims for new intended use or new population or new material or major design change

The application for a test license to import a medical device is filed under form MD-16.

The license pertaining to the import for test, evaluation, clinical investigations is granted using form MD-17 by the Central Licensing Authority.

The results of clinical investigation may not be required to be submitted where the investigational medical device is approved by the regulatory authorities of either the United Kingdom or the United States of America or Australia or Canada or Japan or EU and the said device has been marketed for at least two years in that country and the Central Licencing Authority is satisfied with the data of safety, performance and pharmacovigilance of the device.

No. Medical devices requiring clinical investigation but claiming substantial equivalence to a predicate device shall not be marketed unless the Central Licensing Authority has approved it. A device shall be deemed to be substantially equivalent in comparison to a predicate device, if it has: (i) the same intended use and technological characteristics; or (ii) same intended use and different technological characteristics, and demonstrate that the device is as safe and effective as the predicate device. A claim of substantial equivalence does not mean that the proposed medical device and predicate device are identical. Substantial equivalence shall be established with respect to intended use, design, energy used or delivered, materials, chemical composition, manufacturing process, performance, safety, effectiveness, labeling, biocompatibility, standards, and other characteristics, as applicable.

Clinical performance evaluation means the systematic performance study of a new in vitro diagnostic medical device on a specimen collected from human participants to assess its performance.

Class wise list of medical devices is published on the website of the CDSCO. Provided that the Central Licencing Authority (CLA) may, from time to time, make additions or deletions in such list of medical devices or modify the class of any medical device.

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