New CFDA approval process for in vitro diagnostics

The in-vitro diagnosis reagents refer to the in-vitro diagnosis reagents administered as medical devices, including the reagents, reagent cartridges, calibrators, quality controls, etc. for in-vitro inspection of human body specimen (various body fluids, cells, tissue specimen, etc.) in the course of disease prevention, diagnosis, treatment monitoring, prognosis observation, health status evaluation and inherited disease prediction, which can be used independently or in combination with instruments, devices, equipment or systems. The in-vitro diagnosis reagents legitimately supervised as drug by the state for use in blood screening and radionuclide-labeled in-vitro diagnosis reagents do not belong to the administration scope of medical device.
1^st October 2014, the new came into force, there were many changes in registration of in-vitro diagnostic reagents, especially the oversea product which want to export to Chinese market.

Before you start the program, affirm the following events:
1. If overseas enterprises (manufacturer) want to export their in-vitro diagnostic reagents products to China, should clear classification of the products.
2. When apply for the registration (filing) of a foreign in-vitro diagnosis reagents in China, the foreign sales license for in-vitro diagnosis reagents in original state or region is needed.
If the foreign product is not supervised as a medical device in original state or region, the applicant shall provide related certificate documents, including the foreign sales license in original state or region.
3. The overseas applicant shall appoint only one independent legal entity as its agent in China.
After confirm the above three items, the certificate apply process of overseas in-vitro diagnostic reagents can be started.

In order to get the certificate the oversea in-vitro diagnostic reagents products, the oversea manufacturer and Chinese agent need to cooperate with each other, to complete the following works:

1. Applicant need research and develop products according to related technical standards or via various test method, technical means and provide instructions of rationality. The main tasks are selection and preparation of main raw materials, manufacturing technique confirmation, draft of product technical requirements, stability study, positive judgment value and reference interval confirmation, product analysis performance assessment, clinical evaluation, etc.
2. Applicants shall draft product technical requirements according to results of product research, clinical trials, etc. and national standard, industrial standard, related document literature under the conditions that raw material quality and manufacturing technique is stable. And testing will accord to the technical requirements.
3. After get the testing report, the clinical trials evaluation should be done to assure the products can meet the use requirements or application scope via clinical document literature, clinical empirical data, clinical trials, etc.

Now CFDA give us a probability of clinical trials exemption, if the class II, class III in-vitro diagnostic reagents conform to one of the following circumstances.
1). Clinical samples evaluation covers intended use and interference factor can prove safety and effectiveness of in-vitro diagnosis reagents.
2).Catalogue for in-vitro diagnosis reagents whose clinical trials can be exempted is made, adjusted and issued by CFDA.
4. After finished the Clinical trials, you can submit the certification dossier to CFDA. If CFDA feels the need to check the quality management system when launch the technical evaluation for imported class Ⅱ, class Ⅲ in-vitro diagnosis reagents, it should organize the technical institutions for inspecting the quality management system to check the quality management system.
5. If you passed the quality management system examination, you can get the certificate soon.

Some tips:

1. If overseas enterprise plans to sell their product to China, should plan as soon as possible, the Chinese regulations should be considered in the research and development stage.
2. The protection of intellectual property rights of the company and products need to be done.
3. Should find good partners as an agent, so as not to cause significant loss.
4. We are your good regulation agent, If there is a demand, we can help you.