I. Application and review of the filing certificate
Medical device business enterprises in the second class of medical devices business activities before the need to submit to the local provincial drug supervision and management department to submit a filing application, and submit relevant documents and information. The filing application includes the basic situation of the enterprise, business premises, business product range, quality management system and so on. The drug supervision and management department will review the application materials to ensure that the enterprise meets the conditions and requirements for the operation of Class II medical devices.
Second, the role and significance of the record certificate
The second class of medical devices business record certificate, means that the enterprise has passed the audit of the relevant departments, with the legitimate operation of the second class of medical equipment qualifications. The certificate is not only a proof of legal operation, but also a basis for supervision and management of the business behavior of the regulatory authorities. At the same time, the record certificate also helps to enhance the credibility and competitiveness of the enterprise, providing consumers with safer and more effective medical device products.
Three, the management and use of the record certificate
The second class of medical equipment business record certificate of the enterprise, need to strictly in accordance with relevant laws and regulations and rules and regulations of the requirements, to carry out business activities. At the same time, the enterprise should strengthen the internal management, improve the quality management system, to ensure that the operation of medical equipment products meet the quality standards, to protect the rights and interests of consumers. The regulatory authorities will also regularly supervise and inspect the filing enterprises to ensure that they continue to meet the filing conditions and requirements.
In summary:
The filing certificate of Class II medical device business is one of the necessary conditions for medical device business enterprises to legally carry out business activities, and the enterprises need to apply for filing to the relevant regulatory authorities in accordance with the statutory procedures and requirements, and obtain the certificate after passing the audit. The record certificate can help to ensure the safety and effectiveness of medical devices, enhance the credibility and competitiveness of the enterprise, but also need to strengthen the internal management of the enterprise and comply with the relevant regulatory requirements.
Legal basis:
"Regulations for the Supervision and Administration of Medical Devices"
Article VIII:
To engage in the production of Class II and Class III medical devices, the manufacturer shall apply to the drug supervision and management department of the people's government of the province, autonomous region or municipality directly under the central government for a license to produce and to submit to it proof of conformity with the conditions of the Regulations and the registration certificate of the medical device being produced. Medical device registration certificate. Acceptance of applications for production authorization of drug supervision and management department shall be accepted within 30 working days from the date of application for review of information, in accordance with the State Council drug supervision and management department to develop the requirements of the quality management standard for the production of medical devices for verification, and to make a decision on whether to grant permission. Meet the prescribed conditions, permission and issue a medical device production license; does not meet the prescribed conditions, not licensed and a written explanation of the reasons.
"Supervision and Administration of Medical Devices Regulations"
Article 34 provides:
Medical equipment business enterprises, the use of units purchasing medical devices, should check the qualifications of the supplier and medical equipment qualification documents, the establishment of purchase inspection record system. Engaged in the second class of medical equipment business, by the business enterprise to the municipal people's government in charge of drug supervision and management of the location of the municipal government for the record and submit the conditions of its compliance with the provisions of these regulations.