Medical device labeling, package marking should generally include what content

According to the provisions of Article 13 of the Regulations for the Administration of Medical Device Specifications and Labeling (State Food and Drug Administration Decree No. 6) issued by the State Food and Drug Administration on July 30, 2014:

Article 13 Labeling of medical devices should generally include the following:

(a) product name, model, specifications;

(b ) registrant or filer's name, residence, contact information, imported medical devices should also contain the name of the agent, residence and contact information;

(c) medical device registration certificate number or record certificate number;

(d) the name of the manufacturer, residence, production address, contact information and production license number or production of record certificate number, commissioned production should be marked with the name of the commissioned enterprise. Should be marked entrusted with the name of the enterprise, residence, production address, production license number or production record certificate number;

(v) the date of production, the use of the period or expiration date;

(vi) power connection conditions, input power;

(vii) according to the characteristics of the product should be marked graphics, symbols, and other relevant content;

(viii) the necessary warnings, symbols, and other relevant content;

(viii) the necessary warnings, and other relevant content;

(h) the necessary warnings, and other relevant information ) necessary warnings, precautions;

(ix) special storage, operating conditions or instructions;

(j) the use of medical devices that have a destructive or negative impact on the environment, its labeling should contain a warning sign or warning instructions in Chinese;

(xi) with radiation or radiation medical devices, its labeling should contain a warning sign or warning instructions in Chinese.

(k) with radiation or radiation medical devices, the label should contain a warning sign or Chinese warning instructions.

Medical device labeling due to location or size limitations and can not indicate all of the above, at least should be marked with the product name, model, specifications, date of manufacture and use or expiration date, and in the labeling of clear "other content see instructions".