China NMPA Inspection - Shaanxi Haida Medical Device Technology Co., Ltd. - September 29, 2016

An important report, published on September 29, 2016, details an unannounced inspection of Shaanxi Haida Medical Device Technology Co., Ltd. The inspection was carried out by the Shaanxi Provincial Food and Drug Administration to verify the company's operational status. Previously, on February 6, 2016, Shaanxi Haida Medical Device Technology Co., Ltd. had submitted a "Statement on Production Suspension" to the Shaanxi Provincial Food and Drug Administration and the Xianyang Municipal Food and Drug Administration.

During the on-site verification, the inspection team confirmed that the company was indeed in a state of suspended production. This observation, while confirming the company's statement, highlights the regulatory framework governing medical device manufacturing under the National Medical Products Administration (NMPA) and its provincial authorities.

As a required action, Shaanxi Haida Medical Device Technology Co., Ltd. must submit a comprehensive written report to the Shaanxi Provincial Food and Drug Administration before it can resume any production activities. Production is strictly prohibited from recommencing until the Shaanxi Provincial Food and Drug Administration has officially verified that all relevant requirements have been met and has granted explicit approval.