CONTACT
Headquarters:

Beijing Medicare International Co., Ltd.
Room 817, Tower A, Oulu Plaza
172, Beiyuan Road, Chaoyang District
Beijing, 100101
Email: info@medicareintl.com
Tel: 86-10-84852164
Fax: 86-10-84852134

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SFDA Registration

All imported medical devices to be sold in China must be registered with China’s State Food and Drug Administration (SFDA). And type-testing is required for class II and III medical devices before registration. Clinical trials are required to be included in registration applications for certain class II and III products.
 
BMI has a long-term stable working relationship with SFDA. BMI has a tracking record of successfully obtaining approvals within a shorter period of time. BMI will help you to navigate within the China’s complexes, not yet transparent or consistent regulatory devices system by serving you with:

 Preparation of all documents required for registration application.
• Translation and standard compilation of all paper work—including Certificate of the legal production qualification of the manufacturer; The certificate issued by the government of the Country of Origin to authorize the products as medical devices to enter into the market of the country, such as FDA or CE certificate; Operation Manual; The clinical trial report.
 Providing samples required for testing / trials.
• Sending the samples to an authorized testing center for testing and collecting the testing report.
 Handling trials from beginning to end if clinical trial is required by SFDA.
• Providing professional advice on protocol design and selecting the best suitable hospitals to ensure that the trial result will be accepted by SFDA reviewer and the expert reviewing panel.
 Coordinating and monitoring the trials.
• Long-term cooperation with top hospitals to complete the trial within a shorter period of time.
• Organizing all the documents as required by SFDA, and presenting the completed file to SFDA.
 Providing professional advice to ensure that the registration certificate will best facilitate future marketing, distribution and sales.
• Closely and timely following up with the SFDA reviewing process and keeping our clients informed of each progress till the registration certificate is obtained.

Copyright 2012 Beijing Medicare International Co., Ltd.