CDSCO Approval Process for Medical Devices without Predicate

Introduction:

The landscape of the Indian medical device market is rapidly evolving, with current estimates placing its size at $11 billion, expected to surge to $50 billion by 2025. This growth presents a golden opportunity for manufacturers and importers to introduce their medical devices into India. However, for devices without a predicate, the regulatory approval pathway can be complex. In this blog, we’ll navigate through the process of obtaining approvals for such devices.

Firstly, let’s clarify what we mean by a “medical device without a predicate.” A predicate device, as defined by the Medical Device Rules (MDR) 2017, is one that shares similar intended use, material of construction, and design characteristics with a device already approved by the Central Licensing Authority. Thus, a medical device without a predicate lacks a comparable counterpart under the MDR 2017.

The regulatory pathway for obtaining approval for such devices involves several steps:

1. Clinical Investigation: Manufacturers/importers must conduct clinical investigations to establish safety and efficacy, adhering to guidelines set by India’s Central Drugs Standard Control Organization (CDSCO). Application submission occurs through Form MD-22, with approval granted in MD-23. However, exceptions to clinical investigation requirements exist, as detailed below.

2. Clinical Investigation Exceptions for Class B, C & D: Chapter VIII of the MDR 2017 outlines scenarios where clinical investigation submissions may be waived, such as if the device is approved by regulatory authorities in select countries (UK, USA, Australia, Canada, Japan) and has been on the market for at least two years, among other conditions.

3. Test License & Clinical Investigation Commencement: Following approval, obtain a test license (MD-13 for manufacturing or MD-17 for import) and proceed with clinical investigations.

4. Application for Approval of Medical Device without Predicate: Submit Form-26 for approval, receiving permission in Form MD-27, subject to conditions outlined in Chapter VIII of the MDR 2017.

5. Application for Import/Manufacturing License: Subsequent to MD-27, apply for the import license (MD-14/MD-3/7), submitting necessary documents.

6. Initiate Imports/Manufacture: Upon receipt of the import/manufacturing license, commence import/manufacture activities, ensuring compliance with clinical investigation and other prescribed requirements.

For conducting clinical trials, follow these steps:

1. Identify an Indian Clinical Research Organization (CRO): Select an Indian CRO to manage and oversee clinical trials.

2. Submit Form MD-22 for Clinical Trial Permission: Prepare and submit Form MD-22 with supporting documents to CDSCO, requesting permission.

3. Grant of ‘Permission to Conduct Trials’: Upon review, CDSCO grants ‘Permission to Conduct Trials’ in Form MD-23.

4. Commence Clinical Trials After Approvals: After obtaining approvals and registrations, commence clinical trials.

Conclusion:

Introducing a medical device without a predicate into India’s market offers substantial opportunities but involves regulatory complexities. By meticulously following the approval roadmap and securing necessary permissions, manufacturers/importers can unlock significant benefits. Additionally, partnering with experienced entities like Regulatory Solutions India (RSI) can streamline the approval process, facilitating successful market entry. For more information or assistance, reach out to RSI today.