India’s Quality Control Standards for Medical Devices: Global Comparisons

India’s medical device quality control standards are evolving to align more closely with international benchmarks, enhancing both domestic healthcare outcomes and global market competitiveness.

Bureau of Indian Standards (BIS) Initiatives:

• Formulation of IS 23485: BIS has introduced IS 23485, a comprehensive standard amalgamating ISO 13485:2016 and ISO 16142 guidelines. This standard encompasses quality management system requirements and essential safety and performance principles for medical devices, aiming to harmonize Indian standards with global practices.
• Development of Specific Standards: BIS is actively setting standards for various medical devices, including high-priority and assistive technology devices, to ensure safety, performance, and reliability. The goal is to establish standards for 214 medical devices by 2025, thereby bolstering patient safety and supporting the domestic medical device sector.

Regulatory Framework:

• Medical Device Rules, 2017: These rules mandate that medical devices conform to BIS standards. In the absence of specific BIS standards, devices should comply with those set by the International Organization for Standardization (ISO) or other recognized pharmacopeial standards. This framework facilitates a structured regulatory environment, promoting quality assurance and safety.

Challenges and Comparisons:

• Harmonization with International Standards: While strides have been made, India’s regulatory framework is not yet fully harmonized with international standards such as those of the International Medical Device Regulators Forum (IMDRF) or the European Union’s Medical Device Regulation (MDR). This misalignment can impact international trade and the global competitiveness of Indian manufacturers.
• Testing Infrastructure: India currently has a limited number of certified medical device testing laboratories, which poses challenges for manufacturers seeking timely and efficient product testing. Enhancing this infrastructure is crucial to support the growing medical device industry and ensure compliance with quality standards.