Manufacturing

• SFDA issues State Key Supervised Medical Devices Lists (2009 Edition)
• Provision of Implementation on the Inspection of Quality System of the Oversea Medical Device Manufacturing Enterprises
• Medical Device Manufacturing Enterprise Quality System Inspection Method

    Registration

• SFDA regulates the administration for medical room air sterilization equipments
• SFDA issues the Review and Approval Procedure for Medical Device Registration under Emergency Situation
• SFDA sets out the principles and procedures for the coverage of products included in the quality management system of in-vitro diagnostic reagents
• SFDA drew six technical guidelines of medical device registration
• SFDA standardizes management of labels and packaging marks of overseas medical devices
• SFDA clears up some normative documents on medical device registration
• SFDA further intensifies and standardizes the registration of medical devices
• SFDA specifies relevant requirements on application for alternation of the registration certificate of medical devices
• SFDA issues Procedure for Applying for Cancellation of Medical Device Registration Certificate
• SFDA issues six working procedures including Procedure for Re-issuance of Medical Device Registration Certificate
• Standard Registration Procedure for Domestic Class III Medical Devices and Overseas Medical Devices put into practice
• SFDA issues Guideline for Biological Evaluation and Review of Medical Devices
• SFDA rescinds 51 industry standards for medical devices
• SFDA solicits opinions on Principles of Medical Device Nomenclature
• SFDA further defines the registration of medical devices containing materials from bovine or ovine sources
• SFDA issues 2006 Project Plan of Setting and Revising Industry Standards for Medical Devices
• SFDA issues a notice regarding the registration of medical electrical equipment
• SFDA to further standardize registration testing of medical devices
• SFDA issues Provisions for Medical Device Registration
• SFDA issues its No.10 Order
• Provisions for Clinical Trials of Medical Devices
• Provision on New Medical Device Approval(Interim)
• Provisions for Medical Device Classification
• Regulations for the Supervision and Administration of Medical Devices
• Notice on submission for the registered product standards (trial implementation)
• Re-registration of import products
• Initial registration of import products

    Marketing

• SFDA held video conference deploying supervision of drugs and medical devices used against A (H1N1) flu
• Criteria for Examining and Publishing Medical Device Advertisements
• Provisions for Examining Medical Device Advertisement
• Requirements for Medical Device Adverse Event Monitoring and Re-evaluation (interim) issued
• SFDA further intensifies medical device adverse event surveillance
• SFDA issues Provisions for Medical Device Distributing Enterprise License
• Announcement on relevant issues concerning market access of some imported medical devices