Assistance with SAMR/CFDA Regulations

Medical Device

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Both [Regulations for Supervision and Administration of Medical Devices] and [Provisions for Medical Device Registration] published by CFDA mainly regulates the medical device industry in China. Similar with all other countries, there are 3 categories for medical devices. The difference is CFDA have different requirements for domestic and imported items. There are [Initial registration for overseas medical devices that are approved for marketing at abroad], [Initial registration for overseas Class I medical devices that are not approved for marketing at abroad], [Initial registration for overseas Class II and III medical devices that are not certified for marketing at abroad], and [Notice on overseas IVD registration].

Medical Device Products Registration in China.

According to CFDA regulation, all medical devices only can be sold after investigation and registration. If the applicant is not familiar with the regulations in China, or needs technical assistance during the application, it is a good idea to hire professional consultants to help.

Our services include :

• CFDA regulatory support.
• Device classification according to CFDA medical device regulations.
• Device registration with CFDA.
• Guidance on labeling requirements & labeling review.
• Preparation and/or review of technical documentation.