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Medical devices operation and use

Fourth chapter medical device operation and use

29th medical equipment business, and scale and adapt to business premises and storage conditions, and adapt to and management of medical device quality management system and quality control agencies or personnel.

Article 30th of class II medical devices operation, from enterprises to the local district people's Government municipal food and drug supervision and management departments and submitted to it in accordance with the conditions specified in section 29th supporting information.

Article 31st class III medical device business, and trading enterprises shall, to the seat of the Municipal Government's food and drug supervision and management departments to apply for business license and submit supporting information eligible for article 29th of this Ordinance.

Accept business licenses applied for food and drug supervision and Administration Department shall review within 30 working days from the date of acceptance and, if necessary, organizations to verify. To meet the required conditions, granting licenses and given a medical device license; does not meet the requirements of no permission and to state the reason in writing.

Medical device license is valid for 5 years. Needs to extend the expiry, in accordance with the legal provisions concerning administrative license for continued clearance.

Article 32nd medical device distributing Enterprise purchased, and use of medical devices, shall examine the supplier's qualifications and certificates for medical devices and establish the raw materials purchase check record system. Class II and class III medical device wholesale business as well as class III medical device retail business, sales record-keeping system should be established.