Pathways' Pick of the Week: China’s NMPA Addresses Standards for Clinical Evaluation

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ARTICLE SUMMARY:

China’s National Medical Products Administration updates several clinical trial policies. Excerpted from Pathways’ Picks, September 29.

The NMPA established a new committee in late September to focus on developing and revising standards for medical device clinical evaluation. The 80-member group consists of government officials, healthcare providers, academics, and industry representatives from more than 20 companies, including the China subsidiaries of Medtronic plc, Johnson & Johnson, Roche Diagnostics, and the China Medical Device Industry Association. The group will consider issues like clinical trial quality management, data exchange, and real-world data collection.

NMPA issued five technical guidelines in parallel addressing different elements of medical device clinical evaluation including an overall guideline that defines terms for clinical evaluations and describes trial design, analysis, and reporting details. The other four document address the issues of deciding whether or not to carry out a clinical trial for a device; using clinical evaluation to demonstrate substantial equivalence; submitting clinical evaluation reports; and necessary comparison data and descriptions for devices listed by NMPA as exempt from clinical trials. The guides were issued to help implement provisions of the overarching reforms to China’s device regulatory system that took effect June 1.

Also in late September, NMPA issued a new guidance document outlining technical guidelines for IVD clinical trials. The guidance describes the basic principles of IVD trials conducted in China, expectations for clinical trial protocols and reports, and gets into details on clinical trial design including statistical analysis. NMPA also issued a separate guidance on data expectations for IVDs that it has formally exempted from clinical trials. In these cases, sponsors must submit data comparing the new test with marketed tests on the exemption list to prove substantial equivalence.

NMPA also issued guidance documents animal studies, including a “part 1” guide on decision-making principles for device animal research and a “part 2” document delving into test design and implementation quality assurance for animal studies.

Excerpted from Pathways’ Picks September 29: US Shutdown Looms, User Fee Gap Widens,” Market Pathways, September 29, 2021.

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