What procedures does Panxian need to apply for Lisan medical device business license? Why can't it be an individual enterprise?

First, according to the provisions of Article 31 of the Regulations on the Supervision and Administration of Medical Devices, an operating enterprise shall apply to the food and drug supervision and administration department of the municipal people's government where it is located, and submit a certificate that meets the conditions stipulated in Article 29 of these regulations.

The food and drug supervision and administration department that accepts the application for business license shall conduct a review within 30 working days from the date of acceptance and organize verification if necessary. To meet the prescribed conditions, grant permission and issue a medical device business license; If it does not meet the prescribed conditions, it shall not be permitted and the reasons shall be explained in writing.

The medical device business license is valid for 5 years. If it is necessary to extend the validity period, it shall go through the extension formalities in accordance with the laws and regulations on administrative licensing.

Twenty-ninth engaged in medical device business activities, should have the business premises and storage conditions suitable for the scale and scope of business, as well as the quality management system and quality management institutions or personnel suitable for the medical devices operated. Operating medical devices requires an organization code, which individual enterprises do not have, so it is unacceptable.