China SFDA approval for medical devices and pharmaceutical drugs
Looking to expand your exports into China? Entering the Chinese market offers tremendous opportunity for medical device and pharmaceutical companies, but it is not without risk. Having a partner who understands the opprtunity and compeptive environment of the Chinese marketplace in absolutely essential and can be the difference between success and costly failure.
Emergo Group recognizes the importance of this and spent considerable time finding a partner in China who is experienced with medical device and pharmaceutical approvals and who can guide Western companies through the approval process and beyond.
In 2006, Emergo Group started a partnership with Jyton Group consulting in Beijing. Jyton Group is the largest medical device and pharmaceutical consulting firm in China and submits more medical device and pharmaceutical submissions to the Chinese State Food and Drug Administration (SFDA) than any other firm.
As a result, we can help you:
- Conduct market analysis for your product in China
- Determine the best route to SFDA approval in China
- Develop an SFDA Testing Standard, if required
- Develop clinical protocols and coordinate clinical trials, if required
- Translate documents and labeling
- Complete drug master filing
- Obtain the CCC Mark, if required
- Prepare final submissions and act as official Caretaker in China
- Handle incident reporting, SFDA inspections and renewals
Please contact us today for more information on how Emergo Group can help you obtain SFDA approval for your medical device or pharmaceutical in China.
