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Notice of State Food and Drug Administration on relevant work requirements for registration after adjustment of medical device management category

Notice of State Food and Drug Administration on relevant work requirements for registration after adjustment of medical device management category

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  • Time of issue:2020-09-01
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(Summary description)Food and Drug Administration of all provinces, autonomous regions and municipalities directly under the central government (Drug Administration)
In order to further standardize the registration management of medical devices, in accordance with the relevant provisions of the measures for the administration of registration of medical devices and the notice on printing and distributing the Interim Provisions on Further Strengthening and standardizing the registration management of medical devices (gsyjx [2008] No. 409), the implementation requirements of relevant registration work after the adjustment of the management category of medical devices are hereby notified as follows:
1. The management category has been adjusted from the high category to the low category
(1) for the medical devices that have been approved for registration, if there are no other changes in the products within the validity period of the medical device registration certificate, the re registration matters shall be implemented in accordance with Article 6 of gsyjx [2008] No. 409 document, and the medical device registration certificate within the validity period shall remain valid. The manufacturer shall apply to the corresponding food and Drug Administration for re registration according to the changed category before the expiration of the validity of the medical device registration certificate.
In case of any change specified in Articles 34 and 38 of the administrative measures for registration of medical devices or Article 19 of the regulations on the administration of instructions, labels and packages of medical devices within the validity period, the production enterprise shall apply to the corresponding food and drug regulatory authorities according to the adjusted management category.
(2) the original examination and approval department will no longer accept applications for re registration of products from the date of adjustment of management categories. If the application has been accepted but no approval decision has been made, the original acceptance department shall continue to carry out technical review and administrative examination and approval in accordance with relevant laws and regulations; if the registration is approved, the medical device registration certificate shall be issued according to the original management category.
2. The management category has been adjusted from the low category to the high category
(1) for medical devices that have been approved for registration, the manufacturer shall apply for change and re registration in accordance with Article 35 of the administrative measures for registration of medical devices. For those who apply for change and re registration according to the regulations, the original registration certificate shall remain valid within the validity period before the re registration approval decision is made. If it fails to apply for re registration within 6 months as required, the original registration certificate shall not be used any more.
(2) the original examination and approval department will not accept the application for re registration of products from the date of management category adjustment. If the application has been accepted but no approval decision has been made, the original acceptance department shall carry out technical review and administrative examination and approval in accordance with the requirements of relevant laws and regulations, except for the special provisions of the State Food and drug administration; if the registration is approved, the medical device registration certificate shall be issued according to the original management category. Within 6 months after the product has obtained the registration certificate, it shall apply to the corresponding food and drug regulatory department for change and re registration.
(3) in case of any change specified in Article 38 of the administrative measures for the registration of medical devices or Article 19 of the provisions on the administration of instructions, labels and package labels of medical devices, the manufacturer shall apply to the corresponding food and drug regulatory authorities according to the adjusted management category.
III. information requirements for handling relevant registration applications after adjustment of management category
While submitting the application materials according to the relevant provisions, the production enterprise shall also submit the specifications, standards and other materials approved at the time of original registration. In addition, it is also necessary to submit a self assurance statement on the authenticity of the information to ensure that the application materials are the same as those approved by the original registration examination. When necessary, the food and drug regulatory department may verify the authenticity of the application materials. For products with increased management categories, food and drug regulatory authorities may require ent

Notice of State Food and Drug Administration on relevant work requirements for registration after adjustment of medical device management category

(Summary description)Food and Drug Administration of all provinces, autonomous regions and municipalities directly under the central government (Drug Administration)
In order to further standardize the registration management of medical devices, in accordance with the relevant provisions of the measures for the administration of registration of medical devices and the notice on printing and distributing the Interim Provisions on Further Strengthening and standardizing the registration management of medical devices (gsyjx [2008] No. 409), the implementation requirements of relevant registration work after the adjustment of the management category of medical devices are hereby notified as follows:
1. The management category has been adjusted from the high category to the low category
(1) for the medical devices that have been approved for registration, if there are no other changes in the products within the validity period of the medical device registration certificate, the re registration matters shall be implemented in accordance with Article 6 of gsyjx [2008] No. 409 document, and the medical device registration certificate within the validity period shall remain valid. The manufacturer shall apply to the corresponding food and Drug Administration for re registration according to the changed category before the expiration of the validity of the medical device registration certificate.
In case of any change specified in Articles 34 and 38 of the administrative measures for registration of medical devices or Article 19 of the regulations on the administration of instructions, labels and packages of medical devices within the validity period, the production enterprise shall apply to the corresponding food and drug regulatory authorities according to the adjusted management category.
(2) the original examination and approval department will no longer accept applications for re registration of products from the date of adjustment of management categories. If the application has been accepted but no approval decision has been made, the original acceptance department shall continue to carry out technical review and administrative examination and approval in accordance with relevant laws and regulations; if the registration is approved, the medical device registration certificate shall be issued according to the original management category.
2. The management category has been adjusted from the low category to the high category
(1) for medical devices that have been approved for registration, the manufacturer shall apply for change and re registration in accordance with Article 35 of the administrative measures for registration of medical devices. For those who apply for change and re registration according to the regulations, the original registration certificate shall remain valid within the validity period before the re registration approval decision is made. If it fails to apply for re registration within 6 months as required, the original registration certificate shall not be used any more.
(2) the original examination and approval department will not accept the application for re registration of products from the date of management category adjustment. If the application has been accepted but no approval decision has been made, the original acceptance department shall carry out technical review and administrative examination and approval in accordance with the requirements of relevant laws and regulations, except for the special provisions of the State Food and drug administration; if the registration is approved, the medical device registration certificate shall be issued according to the original management category. Within 6 months after the product has obtained the registration certificate, it shall apply to the corresponding food and drug regulatory department for change and re registration.
(3) in case of any change specified in Article 38 of the administrative measures for the registration of medical devices or Article 19 of the provisions on the administration of instructions, labels and package labels of medical devices, the manufacturer shall apply to the corresponding food and drug regulatory authorities according to the adjusted management category.
III. information requirements for handling relevant registration applications after adjustment of management category
While submitting the application materials according to the relevant provisions, the production enterprise shall also submit the specifications, standards and other materials approved at the time of original registration. In addition, it is also necessary to submit a self assurance statement on the authenticity of the information to ensure that the application materials are the same as those approved by the original registration examination. When necessary, the food and drug regulatory department may verify the authenticity of the application materials. For products with increased management categories, food and drug regulatory authorities may require ent

  • Categories:News Center
  • Author:
  • Origin:
  • Time of issue:2020-09-01
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Information

Food and Drug Administration of all provinces, autonomous regions and municipalities directly under the central government (Drug Administration)
In order to further standardize the registration management of medical devices, in accordance with the relevant provisions of the measures for the administration of registration of medical devices and the notice on printing and distributing the Interim Provisions on Further Strengthening and standardizing the registration management of medical devices (gsyjx [2008] No. 409), the implementation requirements of relevant registration work after the adjustment of the management category of medical devices are hereby notified as follows:
1. The management category has been adjusted from the high category to the low category
(1) for the medical devices that have been approved for registration, if there are no other changes in the products within the validity period of the medical device registration certificate, the re registration matters shall be implemented in accordance with Article 6 of gsyjx [2008] No. 409 document, and the medical device registration certificate within the validity period shall remain valid. The manufacturer shall apply to the corresponding food and Drug Administration for re registration according to the changed category before the expiration of the validity of the medical device registration certificate.
In case of any change specified in Articles 34 and 38 of the administrative measures for registration of medical devices or Article 19 of the regulations on the administration of instructions, labels and packages of medical devices within the validity period, the production enterprise shall apply to the corresponding food and drug regulatory authorities according to the adjusted management category.
(2) the original examination and approval department will no longer accept applications for re registration of products from the date of adjustment of management categories. If the application has been accepted but no approval decision has been made, the original acceptance department shall continue to carry out technical review and administrative examination and approval in accordance with relevant laws and regulations; if the registration is approved, the medical device registration certificate shall be issued according to the original management category.
2. The management category has been adjusted from the low category to the high category
(1) for medical devices that have been approved for registration, the manufacturer shall apply for change and re registration in accordance with Article 35 of the administrative measures for registration of medical devices. For those who apply for change and re registration according to the regulations, the original registration certificate shall remain valid within the validity period before the re registration approval decision is made. If it fails to apply for re registration within 6 months as required, the original registration certificate shall not be used any more.
(2) the original examination and approval department will not accept the application for re registration of products from the date of management category adjustment. If the application has been accepted but no approval decision has been made, the original acceptance department shall carry out technical review and administrative examination and approval in accordance with the requirements of relevant laws and regulations, except for the special provisions of the State Food and drug administration; if the registration is approved, the medical device registration certificate shall be issued according to the original management category. Within 6 months after the product has obtained the registration certificate, it shall apply to the corresponding food and drug regulatory department for change and re registration.
(3) in case of any change specified in Article 38 of the administrative measures for the registration of medical devices or Article 19 of the provisions on the administration of instructions, labels and package labels of medical devices, the manufacturer shall apply to the corresponding food and drug regulatory authorities according to the adjusted management category.
III. information requirements for handling relevant registration applications after adjustment of management category
While submitting the application materials according to the relevant provisions, the production enterprise shall also submit the specifications, standards and other materials approved at the time of original registration. In addition, it is also necessary to submit a self assurance statement on the authenticity of the information to ensure that the application materials are the same as those approved by the original registration examination. When necessary, the food and drug regulatory department may verify the authenticity of the application materials. For products with increased management categories, food and drug regulatory authorities may require enterprises to supplement relevant clinical trial data or post marketing clinical evaluation data according to the needs of system evaluation.
4. It is no longer used as a medical device management product
The food and drug regulatory department will no longer accept its registration application. For those that have accepted but not yet completed the registration approval, the food and drug regulatory department shall not register according to the provisions, and the relevant registration application materials shall be filed. The medical device registration certificate which is still in the validity period shall not be used continuously.
State Food and Drug Administration
February 29, 2012

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