CFDA: New Regulations for the Certification of Denture Implants and 5 additional Products have been published17. June 2016
The CFDA (China Food and Drug Administration) published revised versions of the regulations, which are dealing with the technical verification for the registration of 6 products, in 2016. The intention of that was the improvement of the administration and consultation during the CFDA product registration as well as the review during the registration process.
The revised regulations for medical products of class III include the following products:
- Denture implants
- Dental fillings made out of poly material
- Cerebral shunt for single use
- Surgical yarn
- Posterior fixation system for the spine
- Placeholders made out of synthetic material (Cages) for spinal fusion
There are special requirements for medical products of class III, which are implanted in the human body or which serve life support. These products are a potential risk for the human body. Hence, they have to be checked through product tests and clinical studies.
For the producers of medical products, it is often hard to assess whether a CFDA registration is needed for their products. Moreover, it is hard to assess to which product class their products belong.
Furthermore, the classification is also a decisive influencing factor regarding the costs and the duration of the CFDA registration process . Hereby, it is important to know that the classification in China is not always oriented towards the regulations in Europe (e.g. Regulation 93/42/EWG). Therefore, it is possible that the CFDA classifies products differently than the European authorities.
A well-founded evaluation if a product needs CFDA and to which class it belongs, facilitates the whole certification process and prevents unscheduled costs.
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