Administrative Examination and Approval of Class II Medical Equipment in Shanghai Approved within 10 Working Days.

Recently, Shanghai Municipal Market Supervision and Administration Bureau issues Several Measures on Developing and Expanding Market Players.

The ” Measures” clearly proposes that: implement the action of improving the quality, efficiency and capacity of the examination and approval of medical devices, reduce the average period of examination and approval of class II medical devices to 5 months, and reduce the average time of technical evaluation of first registration by 50% compared with the legal time. Local standards for technical review and approval services forclass II medical devices will also be issued to guide enterprises to standardize registration declaration.

BradyKnows can assist manufacturers in China entry, including facilities establishment, QMS compliance and local manufacturing，please do not hesitate to contact us at info@ inspirativemed.com if you have any interest in bringing your products into China.