国家食品药品监督管理总局令
Order of China Food and Drug Administration

No. 4

Adopted at the meeting of CFDA dated June 27, 2014, these Provisions are hereby promulgated, and shall take effect as of Oct. 1, 2014.

　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　Director ZHANG Yong

2014年7月30日July 30, 2014

医疗器械注册管理办法

Provisions for Medical Device Registration

Chapter I General Provisions

Article 1   The Provisions are formulated in accordance with the Regulations for the Supervision and Administration of Medical Devices with a view to standardizing the administration of medical device registration and filing and guaranteeing the safety and effectiveness of medical devices.

Article 2   All medical devices sold and used within the territory of the People's Republic of China shall apply for registration or conduct filing according to the Provisions.

Article 3   Medical device registration refers to the prescribed procedures conducted by the food and drug regulatory authority upon an application submitted by the registration applicant to decide whether the medical device to be marked can be sold based on a comprehensive evaluation of the research and results of its safety and effectiveness.

Medical device filing is a process that the filing applicant submits the filing documents to the food and drug regulatory authority and the food and drug regulatory authority files the filing documents submitted by the filing applicant.

Article 4   The medical device registration and filing shall be conducted under the principles of publicity, equity and justice.

Article 5   Class I medical device is subject to filing administration and Class II and Class III medical devices are subject to registration administration.

To apply filing for Class I domestic medical devices, the filing applicant shall submit the filing documents to the food and drug regulatory authority of the municipalities consisting of districts.

Class II domestic medical devices shall be inspected by the food and drug regulatory authority of the provinces, autonomous regions and municipalities directly under the central government, and the Registration Certificate for Medical Device will be granted after approval.

Class III domestic medical devices shall be inspected by the China Food and Drug Administration (CFDA), and the Registration Certificate for Medical Device will be granted after approval.

To apply filing for Class I import medical devices, the filing applicant shall submit the filing documents to CFDA.

Class II and Class III import medical devices shall be inspected by CFDA, and the Registration Certificate for Medical Device will be granted after approval.

The medical devices from Hong Kong, Macao and Taiwan shall be registered and filed by reference to the import medical devices.

Article 6   Medical device registration / filing applicant brings product to market in his/her own name and holds liability for the product.

Article 7   The food and drug regulatory authority shall publicize relevant information on medical device registration and filing promptly in accordance with laws. The applicant can look up the approval progress and relevant results as well as the public can look up the result of approval.

Article 8   The State encourages the research and innovation of medical devices, performs the special review and approval for innovative medical devices, accelerates the popularization and application of medical devices as well as promotes the development of medical device industry..

Chapter II Basic Requirements

Article 9  The registration applicant and filing applicant of medical devices shall establish quality management system related to product R&D and manufacturing and keep it to be operated effectively.

When perform the review of registration application of domestic medical devices according to Special Review and Approval Procedure for Innovative Medical Devices, for commissioned manufacture of sample, the commissioned party of the medical device manufacture shall be the manufacturer has related manufacturing range. The commissioned manufacture of sample could not be done in case that it’s not the performance the review of registration application of domestic medical devices according to Special Review and Approval Procedure for Innovative Medical Devices.

Article 10  The persons apply for registration or conduct filing for medical device shall have the corresponding professional knowledge and be familiar with the laws, rules, regulations and technical requirements on the administration of medical device registration/filing.