Rigorous testing and evaluation of medical devices and IVDs is necessary to protect the public health. Medical devices and IVDs have a pivotal role in diagnosis and treatment of diseases and various medical conditions. Hence, regulatory officials have to ensure only high-quality medical devices reach patients. This is a necessary step for enhanced patient safety and improved patient outcome. Thus, the Ministry of Health and Family Welfare, Government of India, has established laboratories to test and evaluate medical devices.

The quality, safety, and performance of medical devices and IVDs have to be rigorously tested before they can be released in the market. The Medical Device Rules (MDR), 2017, has been implemented to monitor and regulate the quality of medical devices/IVDs in India. The medical device and IVD testing facilities are being established under the purview of MDR, 2017. These government medical device and IVD testing facilities have been established for improved healthcare delivery. Furthermore, the Rule 7 of the MDR, 2017, has laid down certain standards and quality benchmarks that medical devices and IVDs have to adhere to.

CDSCO circular regarding testing and evaluation of medical devices and IVDs

Recently, the CDSCO has released a circular regarding testing and evaluation of medical devices and IVDs in government medical device testing laboratories. The government has permitted registration of medical device/IVD testing facilities for testing and evaluation of medical devices and IVDs. The aim is to strengthen and improve the country’s medical devices and IVD testing facilities. This announcement aligns with the Ministry of Health and Family Welfare’s broader goals of improving the reliability and safety of medical devices. It will aid in the Ministry’s aim of enhancing the performance capability, safety, and quality of medical devices and IVDs. This will foster trust regarding medical devices and IVDs available in India among healthcare practitioners and patients. Furthermore, the circular has highlighted the testing standards and quality benchmark for evaluating medical device and IVDs.

Medical devices testing standards and quality benchmark guidelines:

• The circular mentions that medical devices and IVDs are required to conform to the quality benchmark set by the Bureau of Indian Standards (BIS). The medical devices and IVDs have to be evaluated with respect to these standards.
• In case no BIS standard is in place for a particular medical device or IVD, they have to be tested as per internationally recognised standards. The International Organisation for Standardisation (ISO) and the International Electro-Technica Commission (IEC) are some of the internationally recognized standards. The medical device and IVD testing facilities can refer to these standards while performing testing and evaluation of medical devices.
• Moreover, in case no standards are available for any particular device, the medical device should be evaluated with respect to validated manufacturer standards.

Furthermore, the circular highlighted as of January 1, 2018, Drug Rules, 1945, is no longer applicable to medical devices/IVDs. The Medical Device Rules (MDR), 2017, has come into effect for regulation of the quality of medical devices and IVDs in India.

Note: In spite of certain medical devices having available BIS standards, they are not being evaluated accordingly. The circular has warned that these devices have to comply with the BIS benchmark for quality and performance. Furthermore, in absence of applicable BIS standards, the aforementioned guidelines should be followed.

The recent CDSCO circular has highlighted the guidelines for testing and evaluation of medical devices and IVDs. Medical device manufacturers in India have to navigate through multiple guidelines and regulatory requirements. This can be a daunting task. However, with the support from our team of experts, your regulatory journey will be free from hiccups. Drop an email at [email protected] or call/Whatsapp on 9996859227 to embark upon a smooth regulatory journey.