医疗器械注册管理办法(中英文)翻译

医疗器械注册管理办法

Medical Devices Registration Administration Method

总则

Chapter 1 General Provisions

第一条为规范医疗器械的注册管理，保证医疗器械的安全、有效，根据《医疗器械监督管理条例》，制定本办法。

Article 1 To regulate medical device registration management and ensure their safety and effectiveness of medical device, we set down the management measure according to Regulations for the Supervision and Administration of Medical Device.

第二条在中华人民共和国境内销售、使用的医疗器械均应当按照本办法的规定申请注册，未获准注册的医疗器械，不得销售、使用。

Article 2 All the medical device which would like to sell and use within the territory of the People’s Republic of China shall apply for registration complying with this measure. These medical devices which not get China registration approval should be prohibited to sell and use.

第三条医疗器械注册，是指依照法定程序，对拟上市销售、使用的医疗器械的安全性、有效性进行系统评价，以决定是否同意其销售、使用的过程。

Article 3 Medical device registration is the process of doing systemic evaluation of

plan-market medical device on their safety and effectiveness, then decide if medical device can be allowed to sell and use.

第四条国家对医疗器械实行分类注册管理。

Article 4 The state shall classify medical devices and administer them based on this classification.

境内第一类医疗器械由设区的市级（食品）药品监督管理机构审查，批准后发给医疗器械注册证书。

Domestic Class I medical devices shall be inspected, approved and granted with a registration certificate by the food drug regulatory authority of the government of the municipalities consisting of districts.

境内第二类医疗器械由省、自治区、直辖市（食品）药品监督管理部门审查，批准后发给医疗器械注册证书。

Domestic Class II medical devices shall be inspected, approved and granted with a registration certificate by the food drug regulatory authorities of provinces, autonomous regions and municipalities directly under the central government.

境内第三类医疗器械由国家食品药品监督管理局审查，批准后发给医疗器械注册证书。Domestic Class III medical device shall be inspected, approved and granted with registration certificate by State Food Drug Administration.

境外医疗器械由国家食品药品监督管理局审查，批准后发给医疗器械注册证书。Imported medical devices shall be inspected, approved and granted with registration certificate by State Food Drug Administration.

台湾、香港、澳门地区医疗器械的注册，除本办法另有规定外，参照境外医疗器械办理。Taiwan, Hongkong and Macao’s medical device registration shall refer to the regulation of imported medical device.

医疗器械注册证书有效期4年。

Medical devices certificate is valid for 4 years.

第五条医疗器械注册证书由国家食品药品监督管理局统一印制，相应内容由审批注册的（食品）药品监督管理部门填写。

Article 5 Medical devices registration certificate shall be pressed by State Food Drug Administration and the content shall be filled in by inspection department of food drug administration.

注册号的编排方式为：

Registration is arranged as the following:

×（×）1(食)药监械（×2）字××××3第×4××5××××6号。其中：