The Drugs Technical Advisory Board (DTAB) has recommended an amendment to Rule 63 of the Medical Devices Rules (MDR), 2017, to include the European Union (EU) in the list of regulatory agencies whose approvals can exempt medical devices from submitting clinical investigation data for approval in India. This decision aims to align with international standards and streamline approval processes.
The DTAB's recommendation came after considering a proposal to amend sub-rule (1) of Rule 63 in MDR, 2017, which pertains to the requirements for importing or manufacturing medical devices without a predicate device. Currently, the rule specifies that clinical investigation data may not be required if the device is already approved by regulatory authorities in the United States of America, United Kingdom, Australia, Canada, or Japan and has been marketed in that country for at least two years.
During the India-EU Sub-commission on trade in 2018, the EU side noted the exclusion of EU regulatory agencies from this provision. The DTAB acknowledged that the European Medicines Agency (EMA) is considered a stringent regulatory body by the World Health Organization (WHO), ensuring the safety, quality, and performance of medical devices. Consequently, the DTAB recommended including the EU in the provision.
IVD Clinical Performance Evaluation
In contrast, the DTAB reaffirmed its position on Rule 64 of MDR, 2017, which concerns the waiver of clinical performance evaluation for in vitro diagnostics (IVDs). The Board maintained that clinical performance evaluations should not be waived for IVDs due to potential performance variations arising from biological differences among populations and genetic and environmental factors.
"DTAB deliberated the matter and opined that the performance of IVDs can vary significantly due to biological differences among the population, genetic and environmental factors contributing to these variations, making it crucial to assess and confirm the performance of IVDs in Indian population," the Board stated.
This decision underscores the importance of assessing IVD performance within the Indian population to ensure accuracy and reliability. The proposal to add provisions in Rule 64 of MDR, 2017, similar to Rule 63 for IVDs, was thus rejected.
