Medical devices and drugs must obtain SFDA (State Food & Drug Administration) registration before entering China market. Medical devices refer to those instruments, equipment, tools, materials and other objects, including the software attached to them, that are designed to be used either independently or in combination on human body. These devices are used for:
1. Prevention, diagnosis, treatment, monitoring or remission of diseases;
2. Diagnosis, treatment, monitoring, remission or compensation of injury or physical disability;
3. Research, replacement or adjustment of anatomical or physiological process;
4. Control of pregnancy.
Basically, the effect of these devices on human body is not achieved through means of pharmacology, immunology or metabolism; though they might be resorted to in order to bring about certain supplementary effect.
With our professional service in SFDA registration process and good relationship with key persons in SFDA, we can help you compile standard, prepare sample test, follow approval procedure. Deal with the whole procedure effectively and rapidly.

Dossier list:

1. Annual Registration of the manufacturer.
2. ISO Certificate.
3. Document proving the country of the manufacturer has permitted it entering market, such as 510K letter.
4. Operator Manual.
5. Clinical Report.
6. Product Quality Guarantee, should be original.
7. Authorization Letter of Drafting the Product Standard, should be original.
8. Authorization Letter of Registration Agent in China, should be original.
9. Authorization Letter of After-sale Service Agency in China, should be original.
10. Authorization Letter of the Agent in China, should be original.
11. Guarantee the truthfulness of the documents submitted.