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The supervision and inspection of medical devices

The sixth chapter the supervision and inspection

53rd of the food and Drug Administration for medical devices registration, record-keeping, manufacturing, distribution, use, activities to strengthen supervision and inspection, and focus on supervision and inspection on the following matters:

(A) medical device manufacturing enterprises in accordance with the registration or filing of the product technical requirements of production;

(B) whether the quality management system for medical device manufacturers maintain effective operation;

(C) whether the conditions of production and operation of the production and operation of medical devices comply with the statutory requirements.

54th in supervision and inspection, the food and Drug Administration has the following powers:

(A) entry field inspection, sampling;

(B) read, copy, attachment, seizure-related contracts, notes, account books and other relevant materials;

(C) the sealing up, distraining for medical devices does not comply with the statutory requirements, and used spare parts, raw materials, and tools for illegal production of medical devices and equipment;

(D) seizure in violation of the regulations provide for the medical equipment production and business activities of the site.

Food and drug supervision and Administration Department conduct supervision and inspection, shall produce their documents, keep the business secrets of the units inspected.

Units and individuals should be on supporting the supervision and inspection of the food and drug administration, not withholding the information.