Indian medical device OEMs work to steer complex & evolving regulatory frameworks across regions

Indian Medical Device OEMs (original equipment manufacturers) are working to maneuver the complex and evolving regulatory frameworks across regions. These companies need to stay abreast of regulatory updates in the regions where they operate or intend to market their products.

According to Dolly Sharma, practice lead, regulatory affairs, Tata Elxsi, which is a company engaged in designing of medical devices, there is a lack of harmonization in the regulatory requirement that is pertinent to different areas across the globe. It leads to an additional concern of ensuring compliance with stringent quality standards, managing documentation, and reporting requirements.

Further, OEMs also need to address cybersecurity concerns and stay updated with changing regulations. OEMs also are required to balance regulatory compliance with innovation and time-to-market pressures, which further involves handling the high cost of regulatory approvals. They will also need to overcome nonconformities or any adverse events that involve the risk of product recall, warning letters, or regulatory sanctions, she added.

As far as India is concerned, the Indian Medical Device Rules of 2017 is quite new to this segment. Indian OEMs are trying to cope with the adherence to the requirements. Previously, OEMs followed the compliance regulations of the European regulation or US FDA. But now there are certain specific things pertain to Indian medical device rules which include how devices are classified in Indian regulations, Sharma told Pharmabiz.

Yet another is the Quality Assurance and Regulatory Affairs (QARA) which plays a crucial role in medical device companies to ensure the safety, effectiveness, and compliance of the medical devices.

The compliance professionals are responsible for implementing the quality management system (QMS), conducting risk assessments, and overseeing all the regulatory requirements throughout the device lifecycle. Here Tata Elxsi, ensures its QARA professionals connect with regulatory agencies to assist medical device companies with comprehensive documentation, rigorous testing support, and maintain quality processes throughout the product life cycle. Ultimately, their vigilance safeguards patient health and maintains the integrity of devices, she said.

At the same time, we remediate the Quality Management System documentation. Clients are updated with specific recommendations. They are also assisted to establish QMS from scratch and transform it through lean management. Our investments into robotic process automation and Gen AI applications help streamline processes. Stringent regulatory compliances and risk assessment protocols are carried out throughout the process including product realization and robust documentation practices. Even the testing of a medical device is done before it is approved for commercialization to make certain that it adheres to safety guidelines, said Sharma adding that OEMs need to navigate the complex and evolving regulatory frameworks across regions and geographies.