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1、窗体顶端国家食品药品监督管理局令第16号医疗器械注册管理办法于2004年5月28日经国家食品药品监督管理局局务会审议通过，现予公布，自公布之日起施行。局长 郑筱萸二四年八月九日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
2、their safety and effectiveness of medical device, we set down the management measure according to Regulations for the Supervision and Administration of Medical Device. These Measures have been formulated in accordance with the Regulations on the Supervision and Administration of Medical Devices to s
3、tandardize the administration on the medical device registration and ensure the safety and efficiency of medical devices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 Peoples Republic of China s
4、hall apply for registration complying with this measure. These medical devices which not get China registration approval should be prohibited to sell and use. The medical devices sold and used in the territory of the Peoples Republic of China must be registered according to the provisions of these M
5、easures; no medical appliance without registration will be allowed 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
6、decide if medical device can be allowed to sell and use. The medical device registration is a process in which the systematic evaluation on the safety and efficacy of the medical device to be sold on market and used shall be conducted according to the legal procedures so as to determine whether the
7、medical device is 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. The state will implement classified registration management on medical devices.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
8、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. The registration of the domestic Class I medical devices should be examined and approved by the municipali
9、ty (with district)-level (Food and) Drug Administrative Agency and the Medical Devices Registration Certificate will be issued after approved.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
10、the food drug regulatory authorities of provinces, autonomous regions and municipalities directly under the central government. The registration of the domestic Class II medical devices should be examined and approved by the (Food and) Drug Administrative Agency at the level of province, autonomous
11、region or municipality directly under the central government and the Medical Devices Registration Certificate will be issued after approved.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 Dru
12、g Administration.The registration of the domestic Class III medical devices should be examined and approved by the State Food and Drug Administration and the Medical Devices Registration Certificate will be issued after approved.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 in
13、spected, approved and granted with registration certificate by State Food Drug Administration. The registration of the overseas medical devices should be examined and approved by the State Food and Drug Administration and the Medical Devices Registration Certificate will be issued after approved.台湾、
14、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 Macaos medical device registration shall refer to the regulation of imported medical device.Unless otherwise specified in these Measures, the registration of the medical devices in Taiwan, Hong Kong and Macao will be handled by consulting the
15、registration of overseas medical devices.医疗器械注册证书有效期4年。Medical devices certificate is valid for 4 years. The valid period of the Medical Devices Registration Certificate will be four (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 sha
16、ll be pressed by State Food Drug Administration and the content shall be filled in by inspection department of food drug administration.The Medical Devices Registration Certificate should be uniformly printed and manufactured by the State Food and Drug Administration and appropriate contents should be completed by the (Food and) Drug A
