How can Medical Device Manual and Labeling be Standardized?-- Unacceptable Content

On July 30th 2014, China Food and Drug Administration (CFDA) issued the registration regulation about ‘Medical Device Manual and Label Management Regulation’. The regulation defined the content range of the product manual and label.

Product manual and label shall not include the following content:

The affirmation and guarantee words, like the best treatment, the most efficient, radical treatment, no toxin side effect and etc.
The affirmation words such as: the highest technology, the most scientific, the most advanced, the best and etc.
Words state the product recovery rate and effectiveness.
Any words to compare with products' safety and effect from other companies.
Any committed words like having the insurance from the insurance companies, guarantee the refund for ineffective use of the products.
The proofing or recommendation words using any enterprises or individual‘s nominal image.
Misleading descriptions and exaggerated words
The contents that prohibited by laws and regulations.

CIRS Medical Device Manual and Label Compiling Service
If you have any questions about medical device label and manual compiling, please feel free to contact CIRS at md@cirs-group.com.

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