BDe consulting has the experienced specialists in order to be successful in obtaining medical device registration in China. The specialists work closely with our clients, coordinating the submission of regulatory documents, answering CFDA follow up questions and providing insight on how to navigate the evolving regulatory landscape in China.

The therapeutic areas:

Cadio/vascular, Orthopedic/spine/trauma, Nephrology, Onclology, Urology, Endocrinology, Opthalmology, Wound healing, Drug delivery systems, IVDs

The scope of project will include:

Determine device classification;

Ascertain the best route to CFDA approval in China;

Development of a Product technical files;

Choose suitable CFDA qualified labs for type testing;

Translate documents;

Obtain registration certificate.

China local MD&D apply for 510(k), PMA, CE, TGA, etc.

BDe consulting has the experienced specialists in order to be successful in obtaining medical device registration in China. The specialists work closely with our clients, coordinating the submission of regulatory documents, answering CFDA follow up questions and providing insight on how to navigate the evolving regulatory landscape in China.

The therapeutic areas:

Cadio/vascular, Orthopedic/spine/trauma, Nephrology, Onclology, Urology, Endocrinology, Opthalmology, Wound healing, Drug delivery systems, IVDs

The scope of project will include:

Determine device classification;

Ascertain the best route to CFDA approval in China;

Development of a Product technical files;

Choose suitable CFDA qualified labs for type testing;

Translate documents;

Obtain registration certificate.

China local MD&D apply for 510(k), PMA, CE, TGA, etc.