医疗器械安全有效性评价-对构建现行体制下医疗器械科学评价体系的探索

医疗器械安全有效性评价-对构建现行体制下医疗器械科学评价体系的探索
医疗器械安全有效性评价-对构建现行体制下医疗器械科学评价体系的探索
医疗器械安全有效性评价-对构建现行体制下医疗器械科学评价体系的探索
医疗器械安全有效性评价-对构建现行体制下医疗器械科学评价体系的探索

医疗器械安全有效性评价-对构建现行体制下医疗器械科学评价体系的探索

$43.31 In Stock
Item can be returned in its original condition for a full refund or replacement within 30 days of receipt.
Ships from China, Arrives in 7-14 business days
Delivery:
18
November2024
-
27
November2024
Delivery guarantee
$5 Credit If Delayed
Full Refund If Item Is Damaged
15-Day Full Refund If No Updates
30-Day Full Refund If Not Delivered

100% Satisfaction Guarantee

Amazing Value

Fast Shipping

Expert Customer Service

医疗器械安全有效性评价-对构建现行体制下医疗器械科学评价体系的探索

医疗器械安全有效性评价-对构建现行体制下医疗器械科学评价体系的探索

$43.31

内容简介医疗器械是高科技环保产业,是国家经济转型政策重点鼓励和扶植的高新技术产业发展方向。但目前的各项法规和制度安排尚未能够充分体现对行业的有效监管和促进作用。作者认为,首先需要改进现有的市场准入评价模式,建立中国自己的评价体系,以适应医疗器械行业发展的特点和要求。书中所提出的思路和理念是对现有法规和规范的建议、补充和完善,相信定会对促进法规的精细化、系统化、明确化和合理化产生深刻影响。作者希望通过这些思路和体念的提出,能为促进器械监管法规的进一步完善和...
Product Details

内容简介
医疗器械是高科技环保产业,是国家经济转型政策重点鼓励和扶植的高新技术产业发展方向。但目前的各项法规和制度安排尚未能够充分体现对行业的有效监管和促进作用。作者认为,首先需要改进现有的市场准入评价模式,建立中国自己的评价体系,以适应医疗器械行业发展的特点和要求。书中所提出的思路和理念是对现有法规和规范的建议、补充和完善,相信定会对促进法规的精细化、系统化、明确化和合理化产生深刻影响。作者希望通过这些思路和体念的提出,能为促进器械监管法规的进一步完善和提高科学化管理水平尽自己的绵薄之力。
另一方面,科学评价的原理和方法是科学监管的基础和重要组成部分。相信书中所提出的原理和方法必定能为政策制定者、执行者和实践者在制定和执行行业内政策时提供翔实和可操作性强的方案,并给以有价值的前瞻性参考。同时,在不违背科学原则的基础上,制定和形成具有我国特色的市场准人评价模式,提高行业管理质量和执行效率。作者诚恳希望所提出的观点和建议能被政策制定者所重视,并在政策制定过程中能够充分考虑本书所提出的建议和内容。也希望本书的出版和发行能为实现医疗器械科学评价作出应有的贡献。
作者简介

周力田,籍贯湖南长沙,1964年生于北京,1987年毕业于浙江大学科学仪器系生物医学仪器专业,获得学士学位,2001年获得首都经贸大学工商管理专业在职硕士研究生学历。1997年至今,一直工作在国家食品药品监督管理局(前国家医药管理局、国家药品监督管理局)医疗器械技术审评中心。参与过次《医疗器械监督管理条例》和《医疗器械注册管理办法》的制定过程,提出过多项合理化建议并被采纳。具有15年以上的技术审评工作经历和专业知识,积累了丰富的医疗器械市场准入技术审评经验。

目  录
篇 医疗器械评价体系构建
章概述
节 医疗器械技术评价工作发展概况
第二节 存在的问题
第三节 总体思路
第二章分类审评框架思路的提出以及前提条件
第三章 与医疗器械评价有关的通行做法、基本认识、政策解读以及政策
期望
节通行做法
第二节 基本认识
第三节 政策解读
第四节 政策期望
第四章与评价及评价体系有关的定义
第五章建立基于医疗器械分类名录信息系统的注册和备案制度的必要性
书摘插画
插图

Shipping Overview: 

Shipping: Standard Domestic Shipping within the United States charges USD 4.99. Standard International Shipping from United Kingdom, Germany and Japan to the United States charges 14.99. 

Order Processing: Please allow 1-2 business days for order processing and preparation before shipment. 

Domestic Shipping: Orders within the U.S. are shipped via USPS or FedEx, depending on the origin of the product. The average transit time is 3-7 business days. 

International Shipping: Currently, we only ship within the USA. 

Tracking Information: Every order is trackable. You will receive a tracking number once your order has been shipped. Products may be shipped from various global fulfillment centers.

Shipping Delays: 

Please note that shipping times may vary due to factors beyond our control, such as weather conditions, natural disasters, or peak holiday periods. While we strive to ensure timely delivery, the exact arrival time cannot be guaranteed and is managed by the shipping carrier.

Shipping Options:

  • Standard Delivery: Most orders are shipped within 3-7 business days. Larger items may utilize LTL shipping for safe handling.

  • Handling Time: We handle shipments on business days (Monday - Friday), with a preparation time of 1-2 days.

  • Additional Charges: Some items require additional shipping charges due to their size, weight, or special handling. These charges are specified on the product pages and are not eligible for shipping discounts.

  • Exclusions: Gift cards, packaging, taxes, and prior purchases do not count toward the minimum purchase requirement for free shipping. This offer is valid only for shipments to U.S. addresses, including Puerto Rico.

Delivery Details:

  • Estimates: Standard shipping within the US typically takes 3-7 business days. These are estimates and not guarantees.

  • Shipping Restrictions: We ship to all 50 states, Washington, DC, U.S. territories, and APO/FPO/DPO addresses. Shipping options vary based on the delivery address.

  • Remote Areas: Shipments to remote areas may incur additional charges or require pickup from a nearby shipping partner’s location.

Shipping Confirmation:

You will receive a shipping confirmation email with a tracking number as soon as your order is dispatched. If you do not receive this email immediately, please be assured that your items will arrive within the estimated delivery window provided at checkout.

Order Modifications:

If you need to cancel or modify your order, please contact our customer support immediately.

Issues with Delivery:

If your order shows as delivered but you have not received it, please contact the shipping carrier directly to resolve the issue. For persistent problems, contact our customer service at cs@everymarket.com.

Customer Support:

Our team is available 24/7 to assist you with any questions or concerns regarding your order. We are committed to ensuring a smooth shopping experience.

Return & Refund Policy Overview

Please review our return and refund policies below to ensure a smooth transaction process.

Return Policy

  • Duration: You have 30 days from receiving your item to initiate a return.

  • Condition: Items must be unworn, unwashed, with original tags and packaging intact.

  • Shipping Costs: Customers are responsible for return shipping costs.

  • Packaging: Ensure returned items are well-packaged to avoid damage during transit.

  • Tracking: Use a trackable and insured shipping method as we are not liable for items lost or damaged on return.

  • Initiating a Return: Contact us at cs@everymarket.com to start your return. We will provide a return shipping label and instructions upon approval. Returns without prior approval will not be accepted.

How to Return

  • Method: Returns must be sent back by mail to the address provided in the return instructions.

Return Label

  • Defective Products: Return labels are provided for defective items.

  • Non-Defective Returns: Customers are responsible for obtaining their return shipping label.

Product Conditions for Return

  • Eligible Products: Returns are only accepted for items in new condition.

Nonreturnable Items

Certain items are not eligible for return:

  • Electronic devices after 30 days (e.g., computers, laptops, Kindles)

  • Gift cards, prepaid game cards

  • Perishable goods, live insects, some jewelry, some health and personal care items

  • Customized or personalized products

  • Items with special shipping restrictions

Refund Policy

  • Window: Eligible products may be returned within 30 days of delivery for a refund.

  • Refund Method: Refunds are processed to the original payment method or as store credit for items purchased with gift cards.

  • Processing Time: Refunds are processed within 3-5 business days after we receive the return; please allow additional time for shipping and bank processing.

Claims

Inspect your order upon arrival and report any defects, damages, or incorrect items immediately to allow us to address the issue. For claims, contact our support team with details of the issue.

Exchange Policy

For the quickest service, return your original item and place a new order for the desired product once your return is accepted.

Return Address

EveryMarket Customer Service 2101 E Terra Ln, O'Fallon, MO 63366

Customer Support

Available 24/7 for any questions or assistance needed:

  • Phone: +1 636-312-5925

  • Email: cs@everymarket.com

 

内容简介
医疗器械是高科技环保产业,是国家经济转型政策重点鼓励和扶植的高新技术产业发展方向。但目前的各项法规和制度安排尚未能够充分体现对行业的有效监管和促进作用。作者认为,首先需要改进现有的市场准入评价模式,建立中国自己的评价体系,以适应医疗器械行业发展的特点和要求。书中所提出的思路和理念是对现有法规和规范的建议、补充和完善,相信定会对促进法规的精细化、系统化、明确化和合理化产生深刻影响。作者希望通过这些思路和体念的提出,能为促进器械监管法规的进一步完善和提高科学化管理水平尽自己的绵薄之力。
另一方面,科学评价的原理和方法是科学监管的基础和重要组成部分。相信书中所提出的原理和方法必定能为政策制定者、执行者和实践者在制定和执行行业内政策时提供翔实和可操作性强的方案,并给以有价值的前瞻性参考。同时,在不违背科学原则的基础上,制定和形成具有我国特色的市场准人评价模式,提高行业管理质量和执行效率。作者诚恳希望所提出的观点和建议能被政策制定者所重视,并在政策制定过程中能够充分考虑本书所提出的建议和内容。也希望本书的出版和发行能为实现医疗器械科学评价作出应有的贡献。
作者简介

周力田,籍贯湖南长沙,1964年生于北京,1987年毕业于浙江大学科学仪器系生物医学仪器专业,获得学士学位,2001年获得首都经贸大学工商管理专业在职硕士研究生学历。1997年至今,一直工作在国家食品药品监督管理局(前国家医药管理局、国家药品监督管理局)医疗器械技术审评中心。参与过次《医疗器械监督管理条例》和《医疗器械注册管理办法》的制定过程,提出过多项合理化建议并被采纳。具有15年以上的技术审评工作经历和专业知识,积累了丰富的医疗器械市场准入技术审评经验。

目  录
篇 医疗器械评价体系构建
章概述
节 医疗器械技术评价工作发展概况
第二节 存在的问题
第三节 总体思路
第二章分类审评框架思路的提出以及前提条件
第三章 与医疗器械评价有关的通行做法、基本认识、政策解读以及政策
期望
节通行做法
第二节 基本认识
第三节 政策解读
第四节 政策期望
第四章与评价及评价体系有关的定义
第五章建立基于医疗器械分类名录信息系统的注册和备案制度的必要性
书摘插画
插图

Shipping Overview: 

Shipping: Standard Domestic Shipping within the United States charges USD 4.99. Standard International Shipping from United Kingdom, Germany and Japan to the United States charges 14.99. 

Order Processing: Please allow 1-2 business days for order processing and preparation before shipment. 

Domestic Shipping: Orders within the U.S. are shipped via USPS or FedEx, depending on the origin of the product. The average transit time is 3-7 business days. 

International Shipping: Currently, we only ship within the USA. 

Tracking Information: Every order is trackable. You will receive a tracking number once your order has been shipped. Products may be shipped from various global fulfillment centers.

Shipping Delays: 

Please note that shipping times may vary due to factors beyond our control, such as weather conditions, natural disasters, or peak holiday periods. While we strive to ensure timely delivery, the exact arrival time cannot be guaranteed and is managed by the shipping carrier.

Shipping Options:

  • Standard Delivery: Most orders are shipped within 3-7 business days. Larger items may utilize LTL shipping for safe handling.

  • Handling Time: We handle shipments on business days (Monday - Friday), with a preparation time of 1-2 days.

  • Additional Charges: Some items require additional shipping charges due to their size, weight, or special handling. These charges are specified on the product pages and are not eligible for shipping discounts.

  • Exclusions: Gift cards, packaging, taxes, and prior purchases do not count toward the minimum purchase requirement for free shipping. This offer is valid only for shipments to U.S. addresses, including Puerto Rico.

Delivery Details:

  • Estimates: Standard shipping within the US typically takes 3-7 business days. These are estimates and not guarantees.

  • Shipping Restrictions: We ship to all 50 states, Washington, DC, U.S. territories, and APO/FPO/DPO addresses. Shipping options vary based on the delivery address.

  • Remote Areas: Shipments to remote areas may incur additional charges or require pickup from a nearby shipping partner’s location.

Shipping Confirmation:

You will receive a shipping confirmation email with a tracking number as soon as your order is dispatched. If you do not receive this email immediately, please be assured that your items will arrive within the estimated delivery window provided at checkout.

Order Modifications:

If you need to cancel or modify your order, please contact our customer support immediately.

Issues with Delivery:

If your order shows as delivered but you have not received it, please contact the shipping carrier directly to resolve the issue. For persistent problems, contact our customer service at cs@everymarket.com.

Customer Support:

Our team is available 24/7 to assist you with any questions or concerns regarding your order. We are committed to ensuring a smooth shopping experience.

Return & Refund Policy Overview

Please review our return and refund policies below to ensure a smooth transaction process.

Return Policy

  • Duration: You have 30 days from receiving your item to initiate a return.

  • Condition: Items must be unworn, unwashed, with original tags and packaging intact.

  • Shipping Costs: Customers are responsible for return shipping costs.

  • Packaging: Ensure returned items are well-packaged to avoid damage during transit.

  • Tracking: Use a trackable and insured shipping method as we are not liable for items lost or damaged on return.

  • Initiating a Return: Contact us at cs@everymarket.com to start your return. We will provide a return shipping label and instructions upon approval. Returns without prior approval will not be accepted.

How to Return

  • Method: Returns must be sent back by mail to the address provided in the return instructions.

Return Label

  • Defective Products: Return labels are provided for defective items.

  • Non-Defective Returns: Customers are responsible for obtaining their return shipping label.

Product Conditions for Return

  • Eligible Products: Returns are only accepted for items in new condition.

Nonreturnable Items

Certain items are not eligible for return:

  • Electronic devices after 30 days (e.g., computers, laptops, Kindles)

  • Gift cards, prepaid game cards

  • Perishable goods, live insects, some jewelry, some health and personal care items

  • Customized or personalized products

  • Items with special shipping restrictions

Refund Policy

  • Window: Eligible products may be returned within 30 days of delivery for a refund.

  • Refund Method: Refunds are processed to the original payment method or as store credit for items purchased with gift cards.

  • Processing Time: Refunds are processed within 3-5 business days after we receive the return; please allow additional time for shipping and bank processing.

Claims

Inspect your order upon arrival and report any defects, damages, or incorrect items immediately to allow us to address the issue. For claims, contact our support team with details of the issue.

Exchange Policy

For the quickest service, return your original item and place a new order for the desired product once your return is accepted.

Return Address

EveryMarket Customer Service 2101 E Terra Ln, O'Fallon, MO 63366

Customer Support

Available 24/7 for any questions or assistance needed:

  • Phone: +1 636-312-5925

  • Email: cs@everymarket.com

 

Oops!

Sorry, it looks like some products are not available in selected quantity.

OK