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13600366215
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王老师

13600366215

gary.wang@bonnier.net.cn

Wechat:Bonnier-Gary

www.bonnier.net.cn

中国广东省江门市江海区海伦心苑1-3203

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Medical Device Authorised Representative in China

发布时间:2022-07-18 浏览次数:2880

The role of Medical Device Authorised Representative in China(AR Service)

Ⅰ Pre-market of medical device: To manage the registration process with NMPA on behalf of medical device manufacturer, to be the conjunction between NMPA and manufacturer in communications with the foreign establishment and product registration.

Ⅱ Post-market of medical device: To communicate with NMPA or related parties on behalf of medical device manufacturer,responding to questions concerning the foreign establishment´s devices that are imported into China market, to assist the investigation to medical device adverse event.

Medical Device AR Service by Bonnier will assist oversea Medical Device Manufacturer on registration in China for classⅠⅡⅢ Medical Device and on regulation compliance in China.

博尼尔擅长的业务范围:

※医疗器械注册咨询服务:                       ※医疗器械质量管理体系咨询辅导服务:               ※医疗器械授权代表服务:

医疗器械FDA 510k注册服务;                ISO13485认证咨询辅导服务;                            医疗器械英国授权代表UKRP;

医疗器械FDA 510k认证咨询;                医疗器械MDR CE认证咨询辅导服务;                医疗器械瑞士授权代表CH REP;

医疗器械加拿大MDL注册服务;              医疗器械MDSAP认证咨询辅导服务;                 医疗器械美国代理人FDA Agent;

医疗器械MDR CE注册服务。                   医疗器械QSR820法规咨询辅导服务。                医疗器械欧盟授权代表EC REP。



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