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声 明
近期发现有不法分子假借本公司”美中互利（北京）国际贸易有限公司“名义发布一款【互利】APP，通过所谓的会员制购物分享平台，诱导消费者在APP充值，以骗取钱财。就此，本公司郑重声明：
本公司系一家专业从事医疗器械经营的企业，没有开发过任何名为【互利】的APP，亦从未与任何电商平台开展过购物分享、充值返利类的业务；该APP和业务与本公司无任何关系。对于该APP所属主体的行为，实属假冒本公司名义对消费者进行诈骗，谨希望消费者提高警觉，免遭财产损失。
对于恶意伪冒、损害美中互利名誉的行为，我司保留法律追究的权利。
美中互利（北京）国际贸易有限公司
2021年04月15日
京ICP备11010059号-1 
京公网安备11010502035116号 互联网药品信息服务资格证编号（京）-非经营性-2018-0062 版权所有©美中互利医疗有限公司
F A Q
Is it legal for manufacturers to cope with issues of initial registration without an agent ?
Unfortunately, it is NOT legal unless the manufacturers have branches with qualification in China to deal with the registration issues. Otherwise, it is a must-do that manufacturers overseas are required to appoint a Chinese agent for the medical device registration.
How long is the NMPA review process for the initial registration of the medical device ?
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After the registration materials are accepted by NMPA, technical review for Class II medical devices takes 60 working days to process while for Class III medical devices, technical review takes 90 working days. If supplementary materials are required by NMPA, manufacturers are obliged to conduct submission within one year, otherwise the review may result in termination.
In terms of the initial registration for market entry of mainland China, what is the registration fee needed ?
Regarding the registration fee for NMPA, as for the imported medical devices, the registration of Class II medical device needs 210,900 CNY while that of Class III costs 308,800 CNY. In addition, other kinds of possible fees should be taken into consideration such as fees of document translation, clinical trial, and so forth.
Is it possible for a medical device with CE or FDA certificate to enter SAR (HK/MO) and pilot area such as Hainan and the Greater Bay Area ?
MDs with CE or FDA certificate are feasible to enter SAR without NMPA certificate. As for the Greater Bay Area and Hainan province, MDs marketed in HK or MO as a premise can enter the pilot areas if designated medical institutions in pilot areas are willing to procure medical devices out of clinical urgent needs under the approval of local government.
