Jul 15, 2022

Indian medical device market regulators have published new draft in vitro diagnostic (IVD) device rules and made them available for industry comment. In addition, Indian regulators have also issued updated classifications for medical devices used for rehabilitation.

The new rules would apply to any individual or company seeking to sell, supply, exhibit, promote or distribute IVDs or medical devices in India. The Central Drugs Standard Control Organization (CDSCO) issued the draft documents intended to protect public health by monitoring the safety and efficacy of IVDs sold in India. The Drug Controller General of India updated the classification list of medical devices under the rehabilitation category.

CSDSCO releases new draft documents regarding IVD regulations

The proposed rules regarding updates to the regulation of IVD devices have been released for public comment. IVD devices are regulated under the Medical Devices Rules, 2017, and the proposed guidance would take effect upon their final publication in the Official Gazette of India.

First, CDSCO issued Draft Guidance on Post-Market Surveillance of In-vitro Diagnostic Medical Device (IVDMD). This guides the adverse event reporting requirements for Class C and Class D IVDs, point of care tests (POCTs) or human-use IVD medical devices.

The intent of post-market surveillance is to protect patients through continued surveillance of the higher-risk (Class C and Class D) IVDs on the market. The surveillance will be achieved by monitoring and evaluating incidents and, when appropriate, reporting them to reduce the chance of repeated risk occurrences.

Second, the Indian regulator released Overview on Performance Evaluation/External Evaluation of In-Vitro Diagnostic Medical Device (IVDMD). This guidance sets rules that require a performance evaluation/external evaluation for certain IVDs (see link for the list).

Third, CDSCO published Guidance on Stability Studies of In-Vitro Diagnostic Medical Device (IVDMD). These rules are intended to assist manufacturers in preparing scientific information to support the claimed shelf life of IVDs, in use stability and shipping studies for Class C and Class D license applications and post-approval change applications.

DCGI updates classification list for rehabilitation devices

The DCGI has released the updated classification list of medical devices under the rehabilitation devices category, which now includes 70 devices. For details, the classification list is provided in Appendix A of File No. 29/Misc./03/2020-DC (160).

Learn more about medical device and IVD regulations in India:

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    Kathryn Burke

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