Conduct investigations on export medical device companies for epidemic prevention and control

Recently, the Shandong Provincial Drug Administration has deployed the province's epidemic prevention and control of exported medical devices for quality and safety supervision, and organized training on regulations and standards for legal representatives and managers of relevant manufacturing enterprises.

The inspection and bureaus of the Provincial Drug Administration should cooperate closely with the local market supervision departments to carry out a comprehensive investigation of the production and operation enterprises of export medical devices for epidemic prevention and control, establish a list of export enterprises and make dynamic adjustments, and ensure that the export process of export products can be traced. Supervision departments at all levels should maintain special attention to public opinion during special periods, promptly investigate the public opinion information pushed by the Shandong Provincial Drug Administration, and report to the relevant situation in a timely manner.

Establish an epidemic prevention and control medical device export product list and a list of supervisory responsibilities, clarify the target of supervision and supervisory personnel, and ensure that the target of supervision is fully covered without omission. Carry out a comprehensive inspection around the qualifications obtained by relevant enterprises and the management and control of the quality management system. Enterprises must adhere to the bottom line thinking and strengthen risk management. If there is evidence that there is a problem with product quality, they must stop production and business immediately, and control risks in a timely manner. Production and operation must not be resumed until the problems are verified and responsibilities are not clearly identified.