This centralized rectification is mainly aimed at all the enterprises engaged in the second and third types of medical devices in the province. Enterprises with low daily management level, chaotic purchase and sales channels, and frequent cases, and self-inspection found that there are few problems and ineffective rectification measures; engaged in low-temperature, refrigerated medical device business enterprises; imported medical device domestic agents for key inspections And for each key inspection enterprise to extract a number of varieties, carry out upstream and downstream extension inspection of the flow direction and the authenticity of the bill.
If the public finds the following illegal acts, they can call 12331 to report the complaints. Once verified, they will be rewarded according to regulations.
(1) The operating enterprise engaged in the wholesale business of medical equipment is sold to a non-qualified operating enterprise or user unit; the medical device operating enterprise never purchases medical equipment from a qualified production or business enterprise.
(2) The operating conditions have changed, no longer meet the requirements of the medical device management quality management norms, and have not been rectified in accordance with the regulations; unauthorized changes to the business premises or warehouse address, expansion of business scope or the establishment of warehouses without authorization.
(3) Providing false information or taking other deceptive means to obtain the Medical Device Business License; failing to file or provide false information at the time of filing; forging, altering, trading, leasing or lending the Medical Device Business License or "Medical Device Business Recording Voucher".
(4) Those who engage in the operation of Class III medical devices without permission, or fail to continue the medical device operation after the expiration of the validity period of the Medical Device Business License.
(5) Operating the second and third types of medical devices that have not obtained the medical device registration certificate, especially the domestic agents of imported medical devices operating unlicensed products.
(6) Operating medical devices that do not meet the mandatory standards or do not meet the technical requirements for products registered or filed; those that do not have the certificate of conformity, expired, invalid, or eliminated medical devices.
(7) The instructions and labels of the medical devices that are in operation do not comply with the relevant regulations; if the medical devices are not transported or stored in accordance with the medical device instructions and labeling requirements, in particular, the cold chain management of the whole chain is not required for low temperature and refrigerated medical devices. .
(8) failing to establish and implement the medical device purchase inspection record system as required; the operating enterprises engaged in the second and third types of medical device wholesale business and the third type of medical device retail business fail to establish and implement the sales record system as required. .
Medical device operators can take the initiative to find problems before July 15, 2016, and correct other violations of laws and regulations, can be lightened or mitigated according to law; if they fail to report, they will disclose the list of enterprises to the public and list them as key inspection targets. Those who refuse to report, report false reports and self-examination are not serious, and the rectification is not in place, from strict, from re-examination, until the revocation of the "Medical Device Business License"; if the circumstances are serious, it will be in accordance with the "Regulations on the Supervision and Administration of Medical Devices" It is stipulated that the "Medical Device Business License" shall be revoked and notified to the public; if it is suspected of committing a crime, it shall be handed over to the public security organ; if there is a serious violation of law or distrust of the medical device business enterprise, joint punishment shall be implemented in accordance with relevant regulations.
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