The 2005 National Medical Device Regulatory Working Conference held in Shenzhen on February 23,2005 determined the key areas of medical device supervision for this year: (i) Further standardize and improve medical device examination and approval. Strengthen standardized procedures and improve scientific examination. Local areas should set up a mechanism that separates administrative approval and scientific evaluation. All the provincial regulatory departments should establish scientific evaluation centers if they can. (ii) Standards and testing institutions should be set up, focusing on international standard transformation projects and projects that daily supervision much needed. (iii) The daily supervision of manufacturers should be strengthened. Efforts should be continued in GMP developing and implementation for medical device. The daily supervision system should be improved, together with the establishment of a credit system for enterprises. (iv) A system for monitoring and re-evaluating adverse events related to medical device should be established and improved. The key points are to develop, create and issue Provisions for Monitoring and Re-evaluating Adverse Events Related to Medical Device as soon as possible, conduct promotion and training related to the monitoring of medical device adverse events and speed up the drafting of Provisions for Medical Device Recalls.