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What materials are required for the filing of Class II medical devices?

What materials are required for the filing of Class II medical devices?

  • Categories:Industry News
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  • Time of issue:2020-09-15 10:29
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(Summary description)Many people are unfamiliar with the filing of Class II medical devices, and they do not even know that the medical devices they produce belong to Class II medical devices. This article mainly introduces the materials and related content required for the filing of Class II medical devices. What are you waiting for? Come in and take a look! What is the second-class medical device Class II medical devices refer to medical devices whose safety and effectiveness should be controlled. Including X-ray film machines, B-ultrasound, microscopes, biochemical analyzers, etc., all belong to the second category of medical equipment. Article 30 of the "Regulations on the Supervision and Administration of Medical Devices" stipulates that for those engaged in the operation of Class II medical devices, the business enterprise shall file with the food and drug supervision and administration department of the municipal people’s government at the districted level and submit it to the 29th Proof of the required conditions. Article 29 of the "Regulations on the Supervision and Administration of Medical Devices" stipulates that: to engage in medical device business activities, there should be business premises and storage conditions commensurate with the business scale and business scope, as well as a quality management system and a Quality management organization or personnel. Information required for the filing of Class II medical devices The enterprise submits an application to the (food) and drug supervision and administration department of the province, autonomous region, and municipality directly under the Central Government where it is located, fills in the "Medical Device Manufacturing Enterprise License (Opening) Application Form", and submits the following materials: 1. Basic information of the legal representative and the person in charge of the enterprise And qualification certificate; 2. The notice of pre-approval of the name of the proposed enterprise issued by the administrative department for industry and commerce; 3. The resume, academic qualification or title certificate of the person in charge of production, quality and technology of the enterprise; the registration form of relevant professional and technical personnel and skilled workers, and Indicate the department and position; the proportion of senior, intermediate, and junior technical personnel; 4. The scope of the product to be produced, the variety and the introduction of related products; the production site certification document 5. The main production equipment and inspection equipment catalog; 6. The product to be produced The process flow chart of the company, and indicate the main control items and control points; 7. For the production of sterile medical devices, the production environment test report should be provided. Class II medical device filing application process 1. If the application matters are not within the scope of the authority of the department in accordance with the law, the decision of disapproval shall be made immediately and the applicant shall be notified to apply to the relevant administrative agency; 2. If there are errors in the application materials that can be corrected on the spot, the applicant shall be allowed to make corrections on the spot 3. If the application materials are incomplete or do not meet the requirements of the formal examination, a "Notice of Supplementary Materials" shall be issued to the applicant on the spot or within 5 working days, and the applicant shall be notified of all the contents that need to be supplemented and corrected at one time, if the notification is not given after the deadline , The application will be accepted as soon as the date of receipt of the application materials; 4. If the application materials are complete and meet the requirements of the formal examination, or the applicant submits all supplementary application materials as required, it will be accepted. 5. If the (food) and drug supervision and administration department of a province, autonomous region, or municipality directly under the Central Government accepts or refuses to accept an application for the establishment of a medical device manufacturer, it shall issue a "Notice of Acceptance" or "Not Accepted" with the special seal of the department and the date indicated. Acceptance Notice". 6. After reviewing and complying with the regulations, a written decision shall be made to approve the issuance of the certificate, and the "Medical Device Manufacturing Enterprise License" shall be issued within 10 working days. If the requirements are not met after review, a written decision shall be made not to issue a certificate and the reasons shall be explained. Precautions for the filing of Class II medical devices 1. For registered Class II and Class III medical devices, if the contents stated in the medical device registration certificate and its attachments change, the applicant shall apply to the original registr

What materials are required for the filing of Class II medical devices?

(Summary description)Many people are unfamiliar with the filing of Class II medical devices, and they do not even know that the medical devices they produce belong to Class II medical devices. This article mainly introduces the materials and related content required for the filing of Class II medical devices. What are you waiting for? Come in and take a look!

What is the second-class medical device

Class II medical devices refer to medical devices whose safety and effectiveness should be controlled. Including X-ray film machines, B-ultrasound, microscopes, biochemical analyzers, etc., all belong to the second category of medical equipment.

Article 30 of the "Regulations on the Supervision and Administration of Medical Devices" stipulates that for those engaged in the operation of Class II medical devices, the business enterprise shall file with the food and drug supervision and administration department of the municipal people’s government at the districted level and submit it to the 29th Proof of the required conditions.

Article 29 of the "Regulations on the Supervision and Administration of Medical Devices" stipulates that: to engage in medical device business activities, there should be business premises and storage conditions commensurate with the business scale and business scope, as well as a quality management system and a Quality management organization or personnel.

Information required for the filing of Class II medical devices

The enterprise submits an application to the (food) and drug supervision and administration department of the province, autonomous region, and municipality directly under the Central Government where it is located, fills in the "Medical Device Manufacturing Enterprise License (Opening) Application Form", and submits the following materials: 1. Basic information of the legal representative and the person in charge of the enterprise And qualification certificate; 2. The notice of pre-approval of the name of the proposed enterprise issued by the administrative department for industry and commerce; 3. The resume, academic qualification or title certificate of the person in charge of production, quality and technology of the enterprise; the registration form of relevant professional and technical personnel and skilled workers, and Indicate the department and position; the proportion of senior, intermediate, and junior technical personnel; 4. The scope of the product to be produced, the variety and the introduction of related products; the production site certification document 5. The main production equipment and inspection equipment catalog; 6. The product to be produced The process flow chart of the company, and indicate the main control items and control points; 7. For the production of sterile medical devices, the production environment test report should be provided.

Class II medical device filing application process

1. If the application matters are not within the scope of the authority of the department in accordance with the law, the decision of disapproval shall be made immediately and the applicant shall be notified to apply to the relevant administrative agency; 2. If there are errors in the application materials that can be corrected on the spot, the applicant shall be allowed to make corrections on the spot 3. If the application materials are incomplete or do not meet the requirements of the formal examination, a "Notice of Supplementary Materials" shall be issued to the applicant on the spot or within 5 working days, and the applicant shall be notified of all the contents that need to be supplemented and corrected at one time, if the notification is not given after the deadline , The application will be accepted as soon as the date of receipt of the application materials; 4. If the application materials are complete and meet the requirements of the formal examination, or the applicant submits all supplementary application materials as required, it will be accepted. 5. If the (food) and drug supervision and administration department of a province, autonomous region, or municipality directly under the Central Government accepts or refuses to accept an application for the establishment of a medical device manufacturer, it shall issue a "Notice of Acceptance" or "Not Accepted" with the special seal of the department and the date indicated. Acceptance Notice". 6. After reviewing and complying with the regulations, a written decision shall be made to approve the issuance of the certificate, and the "Medical Device Manufacturing Enterprise License" shall be issued within 10 working days. If the requirements are not met after review, a written decision shall be made not to issue a certificate and the reasons shall be explained.

Precautions for the filing of Class II medical devices

1. For registered Class II and Class III medical devices, if the contents stated in the medical device registration certificate and its attachments change, the applicant shall apply to the original registr

  • Categories:Industry News
  • Author:
  • Origin:
  • Time of issue:2020-09-15 10:29
  • Views:
Information

Many people are unfamiliar with the filing of Class II medical devices, and they do not even know that the medical devices they produce belong to Class II medical devices. This article mainly introduces the materials and related content required for the filing of Class II medical devices. What are you waiting for? Come in and take a look!

What is the second-class medical device

Class II medical devices refer to medical devices whose safety and effectiveness should be controlled. Including X-ray film machines, B-ultrasound, microscopes, biochemical analyzers, etc., all belong to the second category of medical equipment.

Article 30 of the "Regulations on the Supervision and Administration of Medical Devices" stipulates that for those engaged in the operation of Class II medical devices, the business enterprise shall file with the food and drug supervision and administration department of the municipal people’s government at the districted level and submit it to the 29th Proof of the required conditions.

Article 29 of the "Regulations on the Supervision and Administration of Medical Devices" stipulates that: to engage in medical device business activities, there should be business premises and storage conditions commensurate with the business scale and business scope, as well as a quality management system and a Quality management organization or personnel.

Information required for the filing of Class II medical devices

The enterprise submits an application to the (food) and drug supervision and administration department of the province, autonomous region, and municipality directly under the Central Government where it is located, fills in the "Medical Device Manufacturing Enterprise License (Opening) Application Form", and submits the following materials: 1. Basic information of the legal representative and the person in charge of the enterprise And qualification certificate; 2. The notice of pre-approval of the name of the proposed enterprise issued by the administrative department for industry and commerce; 3. The resume, academic qualification or title certificate of the person in charge of production, quality and technology of the enterprise; the registration form of relevant professional and technical personnel and skilled workers, and Indicate the department and position; the proportion of senior, intermediate, and junior technical personnel; 4. The scope of the product to be produced, the variety and the introduction of related products; the production site certification document 5. The main production equipment and inspection equipment catalog; 6. The product to be produced The process flow chart of the company, and indicate the main control items and control points; 7. For the production of sterile medical devices, the production environment test report should be provided.

Class II medical device filing application process

1. If the application matters are not within the scope of the authority of the department in accordance with the law, the decision of disapproval shall be made immediately and the applicant shall be notified to apply to the relevant administrative agency; 2. If there are errors in the application materials that can be corrected on the spot, the applicant shall be allowed to make corrections on the spot 3. If the application materials are incomplete or do not meet the requirements of the formal examination, a "Notice of Supplementary Materials" shall be issued to the applicant on the spot or within 5 working days, and the applicant shall be notified of all the contents that need to be supplemented and corrected at one time, if the notification is not given after the deadline , The application will be accepted as soon as the date of receipt of the application materials; 4. If the application materials are complete and meet the requirements of the formal examination, or the applicant submits all supplementary application materials as required, it will be accepted. 5. If the (food) and drug supervision and administration department of a province, autonomous region, or municipality directly under the Central Government accepts or refuses to accept an application for the establishment of a medical device manufacturer, it shall issue a "Notice of Acceptance" or "Not Accepted" with the special seal of the department and the date indicated. Acceptance Notice". 6. After reviewing and complying with the regulations, a written decision shall be made to approve the issuance of the certificate, and the "Medical Device Manufacturing Enterprise License" shall be issued within 10 working days. If the requirements are not met after review, a written decision shall be made not to issue a certificate and the reasons shall be explained.

Precautions for the filing of Class II medical devices

1. For registered Class II and Class III medical devices, if the contents stated in the medical device registration certificate and its attachments change, the applicant shall apply to the original registration department for registration changes and submit the application materials in accordance with relevant requirements. 2. For medical devices that have been filed, the management category is adjusted to the second or third category of medical devices, the filer shall take the initiative to cancel the original filed with the corresponding food and drug regulatory authority. 3. The food and drug administration department at or above the county level shall order corrections within a time limit if the registration items of Class II and Class III medical devices are not changed in accordance with the law.

Class II medical device filing requirements

1. Have a quality management organization or full-time quality management personnel commensurate with the business scale and business scope. Quality management personnel shall have relevant professional academic qualifications or titles recognized by the state; 2. Have a relatively independent business site that is compatible with the business scale and business scope; 3. Have storage conditions that are compatible with the business scale and business scope, including Storage facilities and equipment required by the characteristics of medical device products; 4. A sound product quality management system should be established, including procurement, purchase acceptance, warehousing and storage, outbound review, quality tracking system, and adverse event reporting systems; 5. The ability of technical training and after-sales service suitable for the medical device products operated, or an agreement to provide technical support by a third party.

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