Announcement of the General Administration on the Regulation of Business Operations in the Field of Medical Device Distribution (No. 112 of 2016)

In order to regulate the circulation of medical devices and crack down on illegal business operations, the State Food and Drug Administration has decided to conduct a centralized rectification of illegal business operations in the field of medical device circulation. 1. From the date of this announcement, all enterprises engaged in the second and third categories of medical devices shall conduct self-inspections on whether their enterprises have the following illegal behaviors:

(i) Enterprises engaged in the wholesale business of medical devices sell to unqualified operating enterprises or users; medical device operating enterprises purchase medical devices from unqualified production and operating enterprises.

(ii) The operating conditions have changed and no longer meet the requirements of the medical device business quality management regulations, and the rectification has not been carried out in accordance with the regulations; the business premises or warehouse address have been changed without authorization, the business scope has been expanded, or the warehouse has been established without authorization.

(iii) Providing false information or other deceptive means to obtain the "Medical Device Business License"; failing to register or providing false information when registering; forging, altering, buying and selling, renting, or lending the "Medical Device Business License" or "Medical Device Business Registration Certificate".
(IV) Engage in the business of Class III medical devices without permission, or continue to engage in the business of medical devices without applying for renewal in accordance with the law after the expiration of the validity period of the "Medical Device Business License".

(V) Operate Class II and Class III medical devices without obtaining a medical device registration certificate, especially domestic agents of imported medical devices operate unlicensed products.

(VI) Operate medical devices that do not meet mandatory standards or do not meet the technical requirements of registered or filed products; operate medical devices without qualification certificates, expired, invalid, or obsolete.

(VII) The instructions and labels of the medical devices operated do not comply with relevant regulations; transport and store medical devices in violation of the instructions and label requirements of the medical devices, especially fail to conduct full-chain cold chain management for medical devices that require low temperature or refrigeration.

(VIII) Fail to establish and implement a medical device purchase inspection record system in accordance with regulations; operating enterprises engaged in Class II and Class III medical device wholesale business and Class III medical device retail business fail to establish and implement a sales record system in accordance with regulations.
2. Medical device operating enterprises should conduct self-inspections of their medical device operating behaviors since June 1, 2014 against the above problems one by one, describe in detail the methods used, the process, the medical devices and personnel involved in the existing problems, carefully formulate rectification measures and plans, and form a self-inspection and rectification report, which shall be submitted to the local municipal food and drug regulatory department before July 15, 2016. The legal representative of the enterprise shall sign the report, affix the official seal, and make a commitment to the authenticity, completeness and rectification of the report.
3. If a medical device business enterprise can proactively find problems and correct other illegal and irregular problems before July 15, 2016, it may be given a lighter or mitigated punishment according to law; if it fails to report by the deadline, the municipal-level food and drug regulatory department shall make the list of enterprises public to the society and list them as key inspection targets; those who refuse to report, make false reports or conceal reports, or fail to conduct self-inspection seriously and make inadequate rectification shall be strictly and severely investigated and punished, up to and including revocation of the "Medical Device Business License"; for those who have committed the acts of Items (5), (6), (7) and (8) of Article 1 of this Announcement, if the circumstances are serious, in accordance with the relevant provisions of Articles 63, 66, 67 and 68 of the "Medical Device Supervision and Administration Regulations", their "Medical Device Business License" shall be revoked and made public; those suspected of committing crimes shall be transferred to the public security organs; for medical device business enterprises that have serious illegal and dishonest behaviors, joint punishment shall be implemented in accordance with relevant regulations.

4. All provincial-level food and drug regulatory departments shall timely summarize and carefully analyze the self-inspection and rectification of enterprises. Uniformly train inspection personnel, organize capable forces, adopt cross-regional inspection methods, and implement supervision and inspection in a targeted and focused manner. First, enterprises with low daily management level, chaotic purchase and sales channels, frequent cases, and few problems found in self-inspection and ineffective rectification measures; second, enterprises engaged in the operation of medical devices that require low temperature and refrigeration; third, domestic agents of imported medical devices should be the focus of inspection, and a number of varieties should be selected from each key inspection enterprise to carry out upstream and downstream extended inspections on the flow and authenticity of bills. For cases across administrative regions, a thorough investigation should be conducted by combining case coordination with field investigation. Problems should be effectively discovered during the inspection, and they should be dealt with decisively, and measures should be taken to punish illegal enterprises. Before September 30, 2016, the rectification situation should be summarized and reported to the State Food and Drug Administration. The investigation and handling of specific cases should be reported in a timely manner.
V. Food and drug regulatory departments at all levels should attach great importance to the centralized rectification work, strengthen organizational leadership, arrange special institutions and personnel to implement regulatory responsibilities, strictly enforce work discipline, and strictly crack down on illegal business operations in the field of medical device circulation in accordance with the law. Actively play the role of social supervision, encourage the public to report on corporate illegal activities, and once verified, rewards will be given according to regulations. National unified reporting hotline: 12331.
6. The CFDA will inspect the centralized rectification work carried out in various places and conduct random inspections on the self-inspection and rectification of enterprises. Units and individuals who have found many problems and dare to deal with them resolutely will be praised; those who have not carried out the centralized rectification work effectively will be criticized and reported, and the relevant personnel will be held accountable. The CFDA will continuously improve the supervision system, implement the main responsibility of enterprises, effectively regulate the circulation order of medical devices, and ensure the supply of medical devices and the safety of public use of medical devices.

This announcement is hereby made.

CFDA

May 30, 2016