Dec 26, 2017

In accordance with the requirements of the State Food and Drug Administration, in accordance with the province's medical device special rectification 2015 action plan, the Shandong Food and Drug Administration concentrated on the special rectification of single-use sterile medical devices in August 2015. As of August 31, the province has inspected 91 production enterprises, 2,647 operating enterprises, and 9,538 operating units, filed 208 cases, closed 192 cases, warned and ordered 1,602 rectifications, and ordered the suspension of production and business.

Through inspections, some disposable sterile medical device manufacturers still have problems such as purchase acceptance, production, inspection, and sales records are not standardized, and the training of employees is not in place. Some of the operating and using units still have imperfect purchase acceptance systems. The monitoring of adverse reactions of sterile medical devices is not enough, and the report of adverse reactions to medical devices is not sufficiently positive. As of the end of August, the provincial medical device product quality inspection center completed 177 batches of inspections, and the re-inspection work is currently underway.

In accordance with the requirements of the State Food and Drug Administration, in accordance with the province's medical device special rectification 2015 action plan, the Shandong Food and Drug Administration concentrated on the special rectification of single-use sterile medical devices in August 2015. As of August 31, the province has inspected 91 production enterprises, 2,647 operating enterprises, and 9,538 operating units, filed 208 cases, closed 192 cases, warned and ordered 1,602 rectifications, and ordered the suspension of production and business.

Through inspections, some disposable sterile medical device manufacturers still have problems such as purchase acceptance, production, inspection, and sales records are not standardized, and the training of employees is not in place. Some of the operating and using units still have imperfect purchase acceptance systems. The monitoring of adverse reactions of sterile medical devices is not enough, and the report of adverse reactions to medical devices is not sufficiently positive. As of the end of August, the provincial medical device product quality inspection center completed 177 batches of inspections, and the re-inspection work is currently underway.