Current Regulatory Scenario for Conducting Medical Device Clinical Trials in India

Current Regulatory Scenario for Conducting Medical Device Clinical Trials in India


Medical devices complement the physician’s or surgeon’s expertise in examination, diagnosis, treatment, or follow-up. Access to medical devices helps a physician come up with the right diagnosis of the patient’s medical condition, or a surgeon to carry out a procedure accurately. These devices enjoy equal importance as drugs and are also subjected to clinical trial process through pilot, pivotal and post-approval studies. So clinical trials are conducted worldwide not only by pharmaceutical companies for approval of their drugs, but also by various medical device manufacturers before their devices are introduced in the medical market.

Regulations for medical device clinical trials in India

India is already one of the best destinations to conduct clinical trials for Investigational New Drugs (IND), and various pharmaceutical companies send numerous drugs to be tested on the Indian population for their safety. But this is not the case for medical devices, as earlier, they were put under the same umbrella as new drugs, biologicals, and vaccines. In India, clinical trials were guided by the same regulations, i.e. Schedule Y of the Drug & Cosmetics Rules, 1945. Medical device manufacturers were unwilling to accept these rules, which led to a situation of only a small number of clinical trials for medical devices in India. It took some time for Indian regulations to be amended. The Drugs and Cosmetics Rules, 1945, were reframed for medical devices as Medical Devices Rules, 2017. These rules became effective from January 1, 2018 for medical devices, including in vitro diagnostic kits, surgical dressing, mechanical contraceptives, and others. The Indian Union Government, after consultation with the Drugs Technical Advisory Board, further amended the Medical Device Rules, 2017, to Medical Devices (Second Amendment) Rules, 2019. Also, the rules and regulations for clinical trials of new drugs are amended from time to time to protect the human health by confirming the safety and efficacy of every new drug before its introduction in the market.

The pharmaceutical companies, as well as the medical device manufacturers, are guided by these rules and regulations for clinical trials. Medical device manufacturers must stringently abide by the rules and regulations of the Indian government, when conducting a clinical trial and getting approval for the sale of their products in the Indian market.

What are the Medical Device Rules in India?

Some of the salient features of the Medical Device Rules are listed below. It is necessary for any medical device manufacturer to understand them to subject their devices first for clinical trials, and then introduce them for sale in the Indian market.

  • The rules classify medical devices based upon the intended purpose, invasiveness, and duration of implantation of the device. For example, the invasive medical devices that are intended for less than 60 minutes of continuous use are classified as Class A. The In-Vitro Diagnostic (IVD) medical devices are classified according to the intended purpose of the devices. Thus, there is a need for a clinical trial for each of the classified type of medical device.

  • In case two or more devices are intended to be used with each other, the classification rules of each device shall be applied separately.

  • Earlier, there were only 14 notified categories for investigational medical devices that required investigation. But now there are 351 medical devices under 29 categories, and 247 IVDs under 21 categories that require clinical investigation. A sponsor cannot investigate it without approval from CDSCO (Central Drugs Standard Control Organisation) and the institutional ethics committee. CDSCO approval is required even for a medical device that claims to have substantial equivalence to a predicate device.

  • Similar to the pharmaceutical research, the sponsor is required to give any medical management or compensation, if required, to the patient in case of any causality or death due to the investigational medical device.

  • Every study must be mandatorily enrolled in the Clinical Trial Registry of India before the first patient is enrolled. Further, the status of the study -- open, completed, or terminated -- must be submitted annually to CDSCO by the sponsor.


These are just a few examples of the requirements to conduct a clinical investigation of a medical device in India. But there are many more rules and all of them must be followed stringently for smooth approval of the investigational medical device. There are various forms, data, and other documents that need to be submitted before, during, and after the completion of the investigation. Also, the conduct of the clinical investigation must be done according to the approved study protocol and CDSCO Good Clinical Practices guidelines.

Nitty-gritty of clinical trials for medical devices

Clinical investigation of a medical device is not a simple process, and amendments to the existing rules make it complicated. The pharmaceutical or medical device company may not be aware of the recent amendments, which could cause a delay in the approval or rejection of the application for a clinical trial. Seeking the assistance of an expert who is aware of all the facts and amendments is necessary for the application process to be smooth, until its approval.

CliniExperts is your desired partner possessing expertise for understanding medical trials in India. The medical device clinical trial related services of CliniExperts helps its clients at every step. These include, but not limited to:

  • Investigator / Site Identification

  • Site Training & Management

  • Project Management

  • Vendor Management

  • Medical Writing (E.g., Clinical Study Protocol and Clinical Study Report preparation)

The team consists of well-experienced, qualified, and competent professionals who are always up to date with the latest guidelines and amendments. Our clients speak about their journey, and we are proud of our achievements.


Conclusion

Indian regulations are stringent for clinical investigation of medical devices. To navigate the very complex regulations for medical device clinical trials in India, the manufacturer can shift their burden to CliniExperts and trust them with the journey for a smooth approval.



Frequently Asked Questions

Whether ethics committee approval is mandatory to initiate a clinical trial?

Yes. Clinical trial at each site shall be initiated after the approval of the clinical trial protocol and other related documents by the Ethics Committee for that site, registered with the CLA.

Yes. Before enrolment of first participant in any clinical trial, registration in CTRI is mandatory

Yes. Before enrolment of first participant in any clinical trial, registration in CTRI is mandatory

If a clinical trial site does not have its own ethics committee, clinical trial at that site may be initiated after obtaining approval of the protocol from the ethics committee of another trial site. Provided that the approving ethics committee for clinical trial shall be responsible for the study at the trial site and the same shall be located within the same city or within a radius of 50 kms of the actual clinical trial site.

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.

Minimum of seven members from medical, non-medical, scientific and non-scientific areas with at least, one lay person; one woman member; one legal expert; one independent member from any other related field such as social scientist or representative of non-governmental voluntary agency or philosopher or ethicist or theologian At least 50% of members not affiliated with the institute or organization in which EC is constituted Every member of the EC shall be required to undergo such training and development programs

Yes. The status of enrolment of the trial subjects shall be intimated to the CLA on quarterly basis or as appropriate as per the duration of treatment in accordance with the approved clinical trial protocol, whichever is earlier. Further, six monthly status report of each clinical trial, as to whether it is ongoing, completed or terminated, shall be submitted in SUGAM portal. In case of termination of any clinical trial the detailed reasons for such termination shall be communicated to CLA.

SUGAM portal is an e-Governance solution for CDSCO. SUGAM enables online submission of applications requesting for permissions related to drugs, clinical trials, ethics committee, medical devices, vaccines and cosmetics. SUGAM has facility for users to possess multiple roles on the same registered ID. Applicant can register with different purposes with the assigned roles and forms.

As per the new provision of pre-submission meetings, applicants can discuss their projects with the regulators and subject experts by paying a certain fee, before making actual submission to the regulator, for seeking guidance about the requirements of law and procedure applicable for their projects.

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