Registering Innovative Medical Devices in India

Additional Steps Required for Medical Devices Without a Predicate and Not Marketed for 2+ Years

Innovative device (those without a registered “predicate”) registration in India can be complicated with many variations to the requirements, and options to proceed. Predicate devices are those that are similar in intended use, risk class, material of construction, basic design, and manufacturing, and is already registered by the competent authority in India.

The Predicate device comparison is a crucial part of the registration process for many countries likein the USA (510k), India (Predicate), China (Same-Type), Korea (Substantially Equivalent), Taiwan, and Japan (ninsho). Manufacturers unable to identify a suitable predicate device will often require additional steps such as a clinical investigation and/or post market surveillance reports. In the US, innovative devices are referred to as ‘de novo’ or ‘Breakthrough’ while in Taiwan, they’re referred to as ‘New’, and in Japan, “shonin.” In India such devices are defined as “Investigational Medical Devices” as per the Medical Device Rules, 2017.

Exceptions: Innovative medical devices without a predicate device in India can bypass the additional clinical requirements if it’s been approved by the regulatory authority in any one Reference Country (US, UK, Canada, EU, Australia, or Japan) and successfully marketed for at least two years. Class A devices are also often exempted from these requirements.

Innovative Device Regulatory Pathway

The standard compliance pathway for all devices is to obtain an Import License (Form MD-14 application yields Form MD-15, AKA an import license). Main application components are Device Master File (DMF) and Plant Master File (PMF). Once approved, medical devices will be listed under the Import License assigned to the manufacturing site. For more information on the standard compliance pathway, please click here.

Application Options for Innovative Devices

Manufacturers of innovative devices will have two options depending on their clinical data and the potential predicates devices already on the market. Manufacturers that believe their product has a predicate device on the market can choose to move directly to an MD-14 while manufacturers that know they do not have a sufficient predicate or meet the reference country requirements may choose to apply via a separate regulatory pathway that will involve a review of the investigational medical device by the Subject Expert Committee (SEC) of a particular specialty. However, if the CDSCO finds that the evidence presented in the Form MD-14 is insufficient, the SEC meeting will be requested wherein the applicant can present their case and the total review and outcome could require 3 to 6 months.

SEC meeting are currently held online via Webex once a month depending on expert availability and often have a lead time of 3 months for review of new applications.

Preparing for the CDSCO’s SEC Meeting

The Indian Ministry of Health and Family Welfare has approved panels of experts of various therapeutic areas for evaluation of various categories of applications of Clinical Trials for new drugs and Clinical Investigation for medical devices for marketing in India. SEC usually comprise about eight medical experts including pharmacologists/clinical pharmacologists and medical specialists. CDSCO may add names of experts from government medical college/hospitals or persons of eminence in the panels wherever considered necessary.

SEC evaluation focusses on risk versus benefit, innovation versus existing therapy, unmet medical need, ethical aspects for patient safety, and India-specific concerns if any. The common outcome of the SEC is a determination of the protocols required to generate sufficient local clinical investigation data to fulfil the above focus areas. Manufacturers and their partners should prepare to present product information, clinical data, marketing history, comparisons to other approved products, and additional information as requested by the SEC. Most times, manufacturers will fly in their product experts to ensure questions are effectively answered and work with an experienced local partner like Asia Actual. In current Covid times, online SEC meetings are being held.

Potential SEC Meeting Outcomes

Depending on the SEC’s findings during the meeting, the CDSCO will either waive additional requirements, require the manufacturer to perform a local clinical investigation, and/or submit post market surveillance reports annually for a fixed period of time.

Optimally, manufacturers prefer that the SEC waive the local clinical trial data generation requirement. This typically occurs when existing clinical data from outside India is deemed sufficient to demonstrate device safety. When this occurs, the CDSCO permits the application to proceed directly to an MD-14 submission. Marketing history can also be used to demonstrate safety. Specifically, registration in a reference country with more than 2 years of sale/ marketing without ‘safety concerns.’ SEC may also check on sales numbers and post market surveillance data from the country of origin/ country of manufacture.

Another possible outcome of the SEC is to require a commitment to conduct a Phase IV clinical study. Medical devices requiring a clinical investigation will need to be imported with Form MD-26 for use in the local clinical investigation. Once complete, the clinical data will be included in the Form MD-14 application towards obtaining an Import License.

Lastly, the SEC could determine that a clinical investigation is not required but enhanced post market vigilance reporting in India will need to be completed. In this case, the product can move forward to the application phase and specified post market surveillance reporting will be stipulated as a condition of proceeding directly to Form MD-14.