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What Are the Requirements for Handling Medical Device Business Filing Or Business License

  Author:MeCan Medical–ultrasound machine manufacturers

Management of the second and third categories of medical devices shall hold the "Medical Device Business Enterprise License". In order to prevent the field of medical device operations too chaotic, reducing the health risks of the people, and standardizing the medical device market, my country has gradually improved the requirements of the industry, including personnel, venue, facilities, and business software.

Medical devices are divided into one, second, and third categories; one type of medical device company does not need to apply for a license. It is the same as registering with ordinary companies. It can only operate ordinary medical equipment and equipment. The second category of medical device companies must handle medical device business filing, and the third type of medical device company must apply for medical device business licenses. For medical device sales business, the second and third categories of medical device operations can be operated both but both need to apply for another application.

my country's laws and regulations stipulate that the "Medical Devices Business License" is valid for 5 years and the expiry of the validity period needs to be continued. The medical device business enterprise shall submit the "Medical Device Operation License" to the original issuance department 6 months before the validity period expires. Essence

The original certificate department shall review the application for continuing applications in accordance with the provisions of laws and regulations, and conduct on -site inspections if necessary, and make a decision whether to continue to be allowed before the expiration of the "Medical Device Business License". Those who meet the prescribed conditions are allowed to continue. Those who do not meet the prescribed conditions shall be ordered to rectify within a time limit; if the rectification still does not meet the prescribed conditions, it will not continue. If the decision is not made after the deadline, it is deemed to be allowed to continue.

What Are the Requirements for Handling Medical Device Business Filing Or Business License 1

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