Equivalent to USFDA , State Food and Drug Administration is the supreme governing body for the development, production, distribution, use, supervision and administration of all medical devices and pharmaceuticals (Chinese and western) within mainland China . Since April 2002 , all medical devices made in China or abroad must be registered and approved by SFDA before entering the market. 
SFDA's scope and functions has expanded to includes:
- Registration, testing, and administration of all medical devices;
- Quality standards and inspection;
- Issue of product registration certificates and production licenses;
- Developing, revising, and announcing legal standards for medical devices;
- Establishing catalogs for the classified regulation of medical device products.
Since the first announcement of the regulations in 2000, the administrative procedures and requirements have been amended a number of times, and will continue to be modified in the future to cover new areas and key implementation issues. It helps to have an expert who is aware of the latest regulations, have the ability to maneuver through the bureaucratic maze, maintain the corporate objectives of the clients and complete the task in a timely and efficient manner. Whitney is such expert for you.
We are committed to:
- Execute pre-registration tasks (such as product standard, type testing, translation), compel submission package for registration application;
- Monitor the progress at each step of the registration and intervene when needed;
- Provide regular progress updates to clients;
- Monitor and report on SFDA, CCC and MOH movement and regulations on regular bases;
- Advise clients on compliance issues;
- Work with clients to find the best way to register their products to serve the clients' long-term objectives in China ;
- Have other resources available at client's request (accounting, legal, taxation, after-sale service, administrative);
- Stride for efficiency, management, and peace of mind for our clients.
1.The Basic Procedure for SFDA Certificate Registration
2.Medical Device Classification
3.Phase I Flow Chart for Documents preparation
4.SFDA Registration Application Form Sample
5.SFDA Medical Device Testing Centers in China
6.Some Regulations that were issued by SFDA for Registration
7.FAQ on SFDA Registration |
