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One-time use of high-value medical consumables may cause waste of resources, environmental pollution and rising medical costs.
In practice, some medical consumables can be reused.
Whether medical consumables are for one-time use is determined during the registration approval or filing process, and the instructions for use have clearly stipulated.
According to Article 6 of the Regulations on the Supervision and Administration of Medical Devices (revised in 2017), the list of disposable medical devices shall be formulated, adjusted and published by the food and drug regulatory authority of the State Council in conjunction with the health and family planning authority of the State Council.
In practice, some medical consumables can be reused.
Whether medical consumables are for one-time use is determined during the registration approval or filing process, and the instructions for use have clearly stipulated.
According to Article 6 of the Regulations on the Supervision and Administration of Medical Devices (revised in 2017), the list of disposable medical devices shall be formulated, adjusted and published by the food and drug regulatory authority of the State Council in conjunction with the health and family planning authority of the State Council.
According to Article 35 and Article 68 of the "Regulations on the Supervision and Administration of Medical Devices" (revised in 2017), single-use medical devices shall not be reused, and medical institutions as user units, such as reusing single-use medical devices, Will bear legal responsibilities such as warnings, fines, suspension of production and business by relevant authorities.
Therefore, the Commission will follow the principles of safety, effectiveness and economy, and actively cooperate with the State Food and Drug Administration to adjust the single-use medical device catalog, balance the safety and economy of reuse of single-use medical devices, reduce resource waste, and reduce environmental pollution.
, Reasonably control the increase in medical expenses, and improve the economic burden of patients.
Therefore, the Commission will follow the principles of safety, effectiveness and economy, and actively cooperate with the State Food and Drug Administration to adjust the single-use medical device catalog, balance the safety and economy of reuse of single-use medical devices, reduce resource waste, and reduce environmental pollution.
, Reasonably control the increase in medical expenses, and improve the economic burden of patients.
Three, the next step
In the next step, our committee will carry out work in several areas.
First, it is recommended that the drug regulatory department requires or encourages companies to develop and produce reusable medical consumables when approving the marketing of medical devices .
For those that cannot be reused, they should try their best to choose corresponding alternative products or materials to avoid setting up unreasonable technical barriers.
The second is to cooperate with the drug regulatory department to strengthen research and demonstration, and to support the reuse of clinical norms that can be reused in the diagnosis and treatment process and can be guaranteed to be safe and effective, not included in the catalog of single-use medical devices.
First, it is recommended that the drug regulatory department requires or encourages companies to develop and produce reusable medical consumables when approving the marketing of medical devices .
For those that cannot be reused, they should try their best to choose corresponding alternative products or materials to avoid setting up unreasonable technical barriers.
The second is to cooperate with the drug regulatory department to strengthen research and demonstration, and to support the reuse of clinical norms that can be reused in the diagnosis and treatment process and can be guaranteed to be safe and effective, not included in the catalog of single-use medical devices.
Thank you for your concern and support for health work.
National Health Commission
July 25, 2020
Medical News, February 25
Hello on behalf of:
You have received the "Recommendations on Adjusting Certain Non-implantable High-Value Surgical Instruments in Ophthalmology to the Catalog of Disposable Instruments".
According to the work functions of our committee, our reply is as follows:
According to the work functions of our committee, our reply is as follows:
1.
Work has been carried out
Work has been carried out
Our committee has always attached great importance to the management of clinical use of medical devices.
In order to standardize the management of medical consumables in medical institutions, promote reasonable and standardized use, and ensure medical quality and safety, in June 2019, our committee and the State Administration of Traditional Chinese Medicine issued the "Administrative Measures for Medical Consumables in Medical Institutions (Trial)" to select, Procurement, use, evaluation and monitoring, and other aspects are required.
In January 2020, our committee issued the "First Batch of National Key Management List of High-Value Medical Consumables", and required all localities to formulate a provincial-level list for governance based on actual conditions.
In order to standardize the management of medical consumables in medical institutions, promote reasonable and standardized use, and ensure medical quality and safety, in June 2019, our committee and the State Administration of Traditional Chinese Medicine issued the "Administrative Measures for Medical Consumables in Medical Institutions (Trial)" to select, Procurement, use, evaluation and monitoring, and other aspects are required.
In January 2020, our committee issued the "First Batch of National Key Management List of High-Value Medical Consumables", and required all localities to formulate a provincial-level list for governance based on actual conditions.
2.
Reply to the suggestions made
Reply to the suggestions made
One-time use of high-value medical consumables may cause waste of resources, environmental pollution and rising medical costs.
In practice, some medical consumables can be reused.
Whether medical consumables are for one-time use is determined during the registration approval or filing process, and the instructions for use have clearly stipulated.
According to Article 6 of the Regulations on the Supervision and Administration of Medical Devices (revised in 2017), the list of disposable medical devices shall be formulated, adjusted and published by the food and drug regulatory authority of the State Council in conjunction with the health and family planning authority of the State Council.
In practice, some medical consumables can be reused.
Whether medical consumables are for one-time use is determined during the registration approval or filing process, and the instructions for use have clearly stipulated.
According to Article 6 of the Regulations on the Supervision and Administration of Medical Devices (revised in 2017), the list of disposable medical devices shall be formulated, adjusted and published by the food and drug regulatory authority of the State Council in conjunction with the health and family planning authority of the State Council.
According to Article 35 and Article 68 of the "Regulations on the Supervision and Administration of Medical Devices" (revised in 2017), single-use medical devices shall not be reused, and medical institutions as user units, such as reusing single-use medical devices, Will bear legal responsibilities such as warnings, fines, suspension of production and business by relevant authorities.
Therefore, the Commission will follow the principles of safety, effectiveness and economy, and actively cooperate with the State Food and Drug Administration to adjust the single-use medical device catalog, balance the safety and economy of reuse of single-use medical devices, reduce resource waste, and reduce environmental pollution.
, Reasonably control the increase in medical expenses, and improve the economic burden of patients.
Therefore, the Commission will follow the principles of safety, effectiveness and economy, and actively cooperate with the State Food and Drug Administration to adjust the single-use medical device catalog, balance the safety and economy of reuse of single-use medical devices, reduce resource waste, and reduce environmental pollution.
, Reasonably control the increase in medical expenses, and improve the economic burden of patients.
Three, the next step
In the next step, our committee will carry out work in several areas.
First, it is recommended that the drug regulatory department requires or encourages companies to develop and produce reusable medical consumables when approving the marketing of medical devices .
For those that cannot be reused, they should try their best to choose corresponding alternative products or materials to avoid setting up unreasonable technical barriers.
The second is to cooperate with the drug regulatory department to strengthen research and demonstration, and to support the reuse of clinical norms that can be reused in the diagnosis and treatment process and can be guaranteed to be safe and effective, not included in the catalog of single-use medical devices.
First, it is recommended that the drug regulatory department requires or encourages companies to develop and produce reusable medical consumables when approving the marketing of medical devices .
For those that cannot be reused, they should try their best to choose corresponding alternative products or materials to avoid setting up unreasonable technical barriers.
The second is to cooperate with the drug regulatory department to strengthen research and demonstration, and to support the reuse of clinical norms that can be reused in the diagnosis and treatment process and can be guaranteed to be safe and effective, not included in the catalog of single-use medical devices.
Thank you for your concern and support for health work.
National Health Commission
July 25, 2020
Medical News, February 25
Hello on behalf of:
You have received the "Recommendations on Adjusting Certain Non-implantable High-Value Surgical Instruments in Ophthalmology to the Catalog of Disposable Instruments".
According to the work functions of our committee, our reply is as follows:
According to the work functions of our committee, our reply is as follows:
1.
Work has been carried out
1. Work has been carried out
Work has been carried out
Our committee has always attached great importance to the management of clinical use of medical devices.
In order to standardize the management of medical consumables in medical institutions, promote reasonable and standardized use, and ensure medical quality and safety, in June 2019, our committee and the State Administration of Traditional Chinese Medicine issued the "Administrative Measures for Medical Consumables in Medical Institutions (Trial)" to select, Procurement, use, evaluation and monitoring, and other aspects are required.
In January 2020, our committee issued the "First Batch of National Key Management List of High-Value Medical Consumables", and required all localities to formulate a provincial-level list for governance based on actual conditions.
Medicine Medicine MedicineIn order to standardize the management of medical consumables in medical institutions, promote reasonable and standardized use, and ensure medical quality and safety, in June 2019, our committee and the State Administration of Traditional Chinese Medicine issued the "Administrative Measures for Medical Consumables in Medical Institutions (Trial)" to select, Procurement, use, evaluation and monitoring, and other aspects are required.
In January 2020, our committee issued the "First Batch of National Key Management List of High-Value Medical Consumables", and required all localities to formulate a provincial-level list for governance based on actual conditions.
2.
Reply to the suggestions made
2. Reply to the suggestions made
Reply to the suggestions made
One-time use of high-value medical consumables may cause waste of resources, environmental pollution and rising medical costs.
In practice, some medical consumables can be reused.
Whether medical consumables are for one-time use is determined during the registration approval or filing process, and the instructions for use have clearly stipulated.
According to Article 6 of the Regulations on the Supervision and Administration of Medical Devices (revised in 2017), the list of disposable medical devices shall be formulated, adjusted and published by the food and drug regulatory authority of the State Council in conjunction with the health and family planning authority of the State Council.
Medical devices medical equipment medical equipment drugs drugs drugsIn practice, some medical consumables can be reused.
Whether medical consumables are for one-time use is determined during the registration approval or filing process, and the instructions for use have clearly stipulated.
According to Article 6 of the Regulations on the Supervision and Administration of Medical Devices (revised in 2017), the list of disposable medical devices shall be formulated, adjusted and published by the food and drug regulatory authority of the State Council in conjunction with the health and family planning authority of the State Council.
According to Article 35 and Article 68 of the "Regulations on the Supervision and Administration of Medical Devices" (revised in 2017), single-use medical devices shall not be reused, and medical institutions as user units, such as reusing single-use medical devices, Will bear legal responsibilities such as warnings, fines, suspension of production and business by relevant authorities.
Therefore, the Commission will follow the principles of safety, effectiveness and economy, and actively cooperate with the State Food and Drug Administration to adjust the single-use medical device catalog, balance the safety and economy of reuse of single-use medical devices, reduce resource waste, and reduce environmental pollution.
, Reasonably control the increase in medical expenses, and improve the economic burden of patients.
Therefore, the Commission will follow the principles of safety, effectiveness and economy, and actively cooperate with the State Food and Drug Administration to adjust the single-use medical device catalog, balance the safety and economy of reuse of single-use medical devices, reduce resource waste, and reduce environmental pollution.
, Reasonably control the increase in medical expenses, and improve the economic burden of patients.
Three, the next step
Three, the next step In the next step, our committee will carry out work in several areas.
First, it is recommended that the drug regulatory department requires or encourages companies to develop and produce reusable medical consumables when approving the marketing of medical devices .
For those that cannot be reused, they should try their best to choose corresponding alternative products or materials to avoid setting up unreasonable technical barriers.
The second is to cooperate with the drug regulatory department to strengthen research and demonstration, and to support the reuse of clinical norms that can be reused in the diagnosis and treatment process and can be guaranteed to be safe and effective, not included in the catalog of single-use medical devices.
Enterprise business enterpriseFirst, it is recommended that the drug regulatory department requires or encourages companies to develop and produce reusable medical consumables when approving the marketing of medical devices .
For those that cannot be reused, they should try their best to choose corresponding alternative products or materials to avoid setting up unreasonable technical barriers.
The second is to cooperate with the drug regulatory department to strengthen research and demonstration, and to support the reuse of clinical norms that can be reused in the diagnosis and treatment process and can be guaranteed to be safe and effective, not included in the catalog of single-use medical devices.
Thank you for your concern and support for health work.
Healthy, healthy, healthy National Health Commission
July 25, 2020
