How to Compile Contraindications, Notices, Warning and Tips in the Medical Device Manual for the CFDA Registration

On July 30th 2014, China Food and Drug Administration (CFDA) issued the registration regulation about ‘Medical Device Manual and Label Management Regulation’. And in this regulation, Article 11 mainly explained the details should be included in the Medical Device Manual point 7 contraindications, notices, warning and tips.

The main contents of the medical device manual point 7 contraindications, notices, warning and tips:

Product applicable objects
Potential safety hazards and service restrictions
The safeguard procedures, emergency measures and remedial action for the operators and users under any emergency situation during the correct application process
Necessary monitoring, evaluation and control methods.
The one time use products should mark ‘single- use’. Sterilized products should note the sterilization method and treatment after the broken of sterilized packaging. And also the products that need to be sterilized before usage have to explain the sterilization method.
For the products have to working with other products, it should note the requirements, usage and notices of the cooperated devices.
In the using process, the possible hazards and mutual interference caused by other products.
During the product usage, the possible adverse events or the product ingredients or excipients that might cause the adverse events.
Medical devices waste disposal attentional matters and after use process. And it should note the related processing method.
Based on the product characteristics, it should prompt operators and users other matters that need to pay attention to.

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