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Medical Device Purchases In China To Require Expert Approval

This article was originally published in PharmAsia News

Executive Summary

The Ministry of Health in China revealed that due to the large upfront investment and operational costs which will increase medical fees, big medical equipment and facilities will need expert evaluation and approval before they can be purchased and operated. The ministry requires hospitals and medical organizations installing devices exceeding 5 million yuan ($696,475 )to provide the price breakdown, treatment fees, cost analysis and other details. After giving temporary approval of one to two years, the experts will further assess the safety and effectiveness of the equipment before deciding on granting full approval. The ruling will affect large medical implementations such as PET, gamma ray stereotactic radiotherapy system (Gamma Knife), medical cyclotron, and proton therapy system. (Click here for more - Chinese Language)

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