Testing and Evaluation for Medical Devices/ IVD’s , India

On May 29, 2024, the Central Drugs Standard Control Organisation (CDSCO) issued a crucial circular- File No. MED/48/2024-eOffice. This directive briefs manufacturers on the testing and evaluation of medical devices (MDs) and in vitro diagnostic devices (IVDs) by medical device testing laboratories across India. It aligns with the Ministry of Health and Family Welfare's goals, emphasizing the importance of ensuring the quality, safety, and performance of these medical devices within the country. This CDSCO medical device testing and evaluation standards circular aims to enhance the reliability and safety of medical devices, fostering trust among healthcare providers and patients alike.

The circular stated that the implementation of the Medical Device Rules (MDR) 2017, effective from January 1, 2018, has rendered the older Drug Rules of 1945 inapplicable to medical devices and IVDs. Under the MDR 2017, specific product standards for medical devices are prescribed in Rule 7, making adherence to these standards mandatory. By laying out clear guidelines on testing and evaluation, the CDSCO aims to enhance the reliability and safety of medical devices, fostering trust among healthcare providers and patients alike.

Key Mandates and Implications

The circular underscores several essential points:

Mandatory Compliance with Bureau of Indian Standards (BIS):

• The medical device must conform to the standards set by the Bureau of Indian Standards (BIS), as established under Section 3 of the Bureau of Indian Standards Act, 1985.
• Devices should also comply with any additional standards notified by the Ministry of Health and Family Welfare.
• This ensures that the primary benchmark for medical device quality and safety is rooted in nationally recognized standards, ensuring consistency and reliability.

Adherence to International Standards:

• If no relevant BIS standard exists for a specific medical device, the device must then conform to internationally recognized standards.
• These include standards set by the International Organisation for Standardisation (ISO) or the International Electrotechnical Commission (IEC), among others, such as pharmacopeial standards.
• This provision allows for global standards to be used in the absence of specific Indian standards, facilitating international compliance and enhancing the credibility of Indian medical devices on a global scale.

Manufacturer’s Validated Standards:

• In cases where neither BIS nor international standards are specified, the device must conform to the manufacturer’s validated standards.
• These standards must be validated to ensure they meet the necessary safety and performance criteria.
• This flexibility allows manufacturers to use their own standards, provided they are thoroughly validated, ensuring that all medical devices still meet essential safety and quality benchmarks.

Conclusion

The CDSCO’s recent circular is a significant step towards ensuring the highest quality and safety of medical devices in India. By requiring conformity to BIS standards, international benchmarks, or validated manufacturer standards, the CDSCO ensures that all medical devices in the market are reliable and safe for use. For manufacturers and importers, understanding and adhering to these standards is crucial. Morulaa’s expertise in regulatory compliance, particularly with the MD-14 form and SUGAM portal, can streamline this process, helping you achieve swift and efficient approval for your medical devices. For detailed guidance and support, please contact our regulatory experts today. To know more about how we can support you, Click Here or email us on [email protected].