Medical Device Registration
YTC's services include:
China Compulsory Certification (CCC)(when required)
Development of SFDA testing standard
Clinical study and technical reports (when required)
Document translation
Clinical trials (when required)
Final submission filing
Caretaker services
On-going maintenance of approvals include application renewal services and incident reporting.

Medical Device Documentation
General documentation requirements for the SFDA submission:
Manufacturer's business license
Device name and classification
Package insert/statement of indication(s) for use
Packaging and labeling samples
Description of device includes diagrams, drawings, etc.
Quality control documentation
Clinical trial (if required)
Results of testing required by SFDA (to be done in China)
Statement confirming truthful and accurateness of information
Authorization letter naming distributor in China for product
Authorization letter naming regulatory consultant representing manufacturer/customer

Note: Documentation requirements may vary based on the type of medical device. This is just a general overview.

Medical devices and equipment that require CCC certification include:
Medical Diagnostic X-Ray Equipment
Haemodialysis Equipment
Hollow Fiber Dialysers
Extra-corporeal Blood Circuit for Blood Purification Equipment
Electrocardiographs
Implantable Cardiac Pacemakers
Artificial Heart-Lung Machine

Pharmaceutical Registration
YTC provides pharmaceutical registration and complete clinical support, include:
Clinical protocol development
CRF and ICF design
Coordinating and monitoring clinical trials in China
Data management, statistical analysis and reporting
Document translation
Drug master filing
Final submission filing
Overseeing SFDA inspections
Caretaker services
On-going maintenance of approvals include application renewal services and incident reporting.

Pharmaceutical Documentation
General documentation requirements for the SFDA submission:
Drug name and description
Method of drug manufacture and packaging
Specifications and analytical methods for drug product
Pharmacology and toxicology studies data
Pharmacokinetics and bioavailability data summary
Microbiology summary
Clinical trial data summary and results of statistical analysis
Packaging and labeling samples
Package insert

Note: Documentation requirements may vary based on the type of pharmaceutical product. This is just a general overview.

Other Product Registrations
Other Health Foods/Cosmetic Products/Disinfectant Solutions and Equipment Registration
YTC provides regulatory support for companies seeking to register their health food products, cosmetic products and disinfectant products and equipment for sale in China.
YTC also offers caretaker services dedicated to ongoing maintenance of existing approvals, application renewal services and incident reporting.

Your Benefits
Our highly qualified regulatory staff has years of experience working with the Chinese State Food and Drug Administration (SFDA) and the Chinese Ministry of Health (MOH).
YTC works with customers to design the most efficient registration strategy in order to achieve the most streamline, cost effective and efficient filing process.