2019年越南河内国际制药医疗器械展览会vietnam medipharm
MDD指南,MEDDEV 2.12-1 rev.8-2013.01, 医疗器械警戒系统指南
Revision 8 of MEDDEV 2.12-1 explicitly includes IVF/ART devices within the scope of the vigilance system and provides clarity in relation to devices that are not intended to act directly on the individual. The revised guidance will be applicable as of July 2013.
3 SCOPE ............................................................................................................................................. 5 3.1 GENERAL PRINCIPLES ...................................................................................................... 6 3.1.1 FOR MANUFACTURERS .................................................................................................. 6 3.1.2 FOR MANUFACTURERS OF DEVICES THAT ARE NOT INTENDED TO ACT DIRECTLY ON THE INDIVIDUAL ............................................
中国医学装备协会《新冠肺炎疫情防治急需医学装备目录(第3批)》
北京新科华大医疗技术有限公司
费森尤斯卡比（中国）投资有限公司/德国 北京思路高医疗科技有限公司
河南通盛易达医用电子设备股份有限公司
北京来普惠康医学技术有限公司
费森尤斯卡比（中国）投资有限公司/德国
10
肠内营养泵
北京麦康医疗器械有限公司
北京灵泽医药技术开发有限公司
纽迪希亚(中国)营养医药有限公司
费森尤斯卡比（中国）投资有限公司/德国
参考型号
Medin-CNO、Medin-CNO-3090
是否进入 遴选目录
S9600 VENTImotion2、VENTImotion30、
VENTImotion advance
Vivo 30 / Vivo 40
bellavista1000
BPAPHE、BPAP30 DM15T、DM16T、DM16B、DM28-25ST-BP
Apogee 1200
Apogee 1T C6、C5 PA10L、PA12A、PA12W SINOMAGE系列 K2、K0
是否进入 遴选目录
是
是否外企
是 是
是
BodyTom NL4000
是
NeuVision450、NeuVision460、NeuVision470 、NeuVision480
是
DigiEye 680T
SDMS G3D、G3M、G3C、G3N、G1B NS-BO系列
是否进入 遴选目录
是否外企
是
是
是 是
是 是 是 是
是
MB800中央监护系统、动态800F+、动态 800HS、动态800H、动态800B、CD2000、 CD2000+、MB526、MB526+、MB526T8、 MB526T12、MB526T17、M1720、M1720A
中越卫生合作需求与策略
Chinese Journal of Health Policy，May 2019,Vol. 12 No. 5全球卫生.中越卫生合作需求与策略钱稳吉‘朱思祝雯環贺尧黄葭燕复旦大学公共卫生学院国家卫生健康委员会卫生技术评估重点实验室上海200032【摘要】目的：通过分析越南的卫生合作需求，提出中越卫生合作的策略建议。
方法：通过二手资料收集 和定性访谈，收集健康相关可持续发展目标（SDG)数据、越南卫生发展规划、国际组织对越援助以及中越卫生 合作现况。
结果：越南以SDG为基础，规划优先发展领域。
国际组织对越南卫生发展起到重要作用，但随着越 南的经济发展，部分组织开始撤资。
中越目前主要在多边合作框架下开展卫生合作，合作内容涉及卫生安全、卫生发展和医学创新。
结论：中越卫生合作应根据两国卫生发展水平、卫生合作基础及国家发展规划决定合 作的领域和方式。
两国的卫生合作应随双方的发展进程和需求变化而动态调整。
除了中越两国的资源，其他 国际资源的有效利用也有助于卫生合作的推进。
【关键词】一带一路；卫生合作；越南中图分类号：R197 文献标识码：A doi: 10. 3%9/j. issn. 1674-2982. 2019. 05. 009Analysis of Sino-Vietnamese health cooperation needs and strategiesQIAN Wen-ji, ZHU Si, ZHU Wen-jun, HE Yao, HUANG ]ia-yanNHC Key Laboratory of Health Technology Assessment, School of Public Health, Fudan University, Shanghai 200032, China 【A bstract】Objective: This paper aims to explore Vietnam’s health cooperation needs in order to propose sug- gestions on Sino-Vietnamese health cooperation strategies. Methods ： Through data collection and qualitative interviews ,data on the status quo of health-related sustainable development goals ( SDGs) of China and Vietnam, Vietnam’s health development plan, international aid and current Sino-Vietnamese health cooperation are collected. Results：Based on the domestic SDG situation, Vietnam prioritizes areas in health development and international organizations play an important role in Vietnam^ health development. As the Vietnam’s economy has improved, some international organizations have begun to reduce their investments and aids in Vietnam. The current health cooperation between China and Vietnam is mainly based on the multilateral cooperation framework, involving health security, health development, and health innovation. Conclusions：The Sino-Vietnamese health cooperation should determine the areas and mechanisms of cooperation according to the level of health development, the basis of health cooperation and the national health plan. Health cooperation between the two countries should be dynamically adjusted as the health development process and needs of both countries change. In addition to the resources of China and Vietnam, the effective use of other international resources can also contribute to the further promotion of health cooperation.【Key words】Belt and Road Initiative; Health cooperation; Vietnam“一带一路”倡议的提出为我国卫生产业的发展 提供了良好的机遇，不仅带来了庞大的国际医疗产 业市场，也通过国际卫生合作达到“引进来”、“走出 去”互惠互利的作用。
中国药品及医疗器械进军越南市场正当时
中国药品及医疗器械进军越南市场正当时
佚名
【期刊名称】《技术开发与贸易机会》
【年(卷),期】2002(000)007
【总页数】2页(P3-4)
【正文语种】中文
【中图分类】F426.7
【相关文献】
1.进军中国正当时--访山特维克矿山工程机械(中国)有限公司 [J], 汪芙蓉
2.中国商品进军印度正当时 [J], 张平
3.第22届中国内镜医师大会、恩德思医学科学技术奖颁奖大会暨第22届恩德思世界医疗器械药品博览会在中山市召开 [J],
4.2012年《第22届中国内镜医师大会》、恩德思医学科学技术奖颁奖大会暨第22届恩德思世界医疗器械药品博览会在中山市召开 [J],
5.药械审评审批制度改革完成顶层设计中国医药产业进入系统化创新时代总局召开新闻发布会解读《关于深化审评审批制度改革鼓励药品医疗器械创新的意见》[J], 刘云涛;王国庆
因版权原因，仅展示原文概要，查看原文内容请购买。
今年越南药品药材进口额将增长10％
今年越南药品药材进口额将增长10％
佚名
【期刊名称】《中医药国际参考》
【年(卷),期】2006(000)010
【摘要】越南卫生部下属的药品局官员10月19日说，今年越南预计进口药材（制药原料）和药品总额达7．1亿美元，比去年增长10％，主要进口自法国、德国、意大利、波兰和美国。
【总页数】1页(P21)
【正文语种】中文
【中图分类】R282
【相关文献】
1.越南今年1～10月出口增长7.3% [J],
2.今年前10个月越南对华出口增长48％ [J],
3.越南预计今年皮革和鞋业出口增长10% [J],
4.挪威今年1月医药品进口额增长 [J], 张亦农
5.越南今年前10个月果蔬出口额同比增长13．4％ [J],
因版权原因，仅展示原文概要，查看原文内容请购买。
药交会作文模板
药交会作文模板英文回答：The China International Pharmaceutical Machinery and Packaging Exposition (CIPM) is an annual international exhibition dedicated to the pharmaceutical machinery and packaging industry. It is held in different cities in China each year, and it attracts exhibitors and attendees fromall over the world.CIPM is a leading platform for pharmaceutical machinery and packaging manufacturers to showcase their latest products and technologies. It also provides opportunitiesfor buyers and suppliers to network and do business.The exhibition covers a wide range of topics, including: Pharmaceutical machinery。
Packaging machinery。
Raw materials and ingredients。
Testing and analysis equipment。
Logistics and distribution services。
In addition to the exhibition, CIPM also includes a series of conferences and seminars on the latest trends in the pharmaceutical machinery and packaging industry.CIPM is an important event for anyone involved in the pharmaceutical industry. It is a great opportunity to learn about the latest technologies, meet with suppliers, and do business.中文回答：中国国际医药机械及包装展览会（CIPM）是一年一度的国际性展览会，专注于医药机械和包装行业。
养血清脑颗粒申报进入越南医药市场的研究
养血清脑颗粒申报进入越南医药市场的研究 □ 朱永宏 赵利斌 郭治昕 张万良 （天津天士力集团研究院 天津 ３００４１０） 摘要：在越南中成药市场高速发展的背景下，本文以越南申请处方药为例，简述越南对中药处方药审评的技术要求，提出了开展中药申报有关思路和观点，为我国中成药企业进入越南市场提供了很好的经验，对于我国中成药在越南市场的拓展打下良好的基础。
Studies on the Launch of Pharmaceutical Market for Traditional Chinese Medicine(TCM) in VietnamZHU Yonghong, ZHAO Libin, GUO Zhixin, ZHANG WanglianAbstractUnder the background of rapid development of Chinese Proprietary Medicine market in Vietnam, the article has been given a brief review on technical requirements of the evaluation of Chinese Proprietary Medicne and indicated relevant idea and views of the application as the example of prescription drug application in Vietnam. The article was provided good experiences for Chinese Proprietary Medicine manufacturers in our country to enter into Vietnamese medical market, and also established the foundation for the development of Chinese Proprietary Medicine in Vietnamese market.Ⅰ背景 越南是一个具有８０００万人口，ＧＤＰ高速增长的国家，目前，正面临着从社会主义计划经济向市场经济转型的快速发展时间。
（Annex19）totheEUGMPGuide-EuropeanCommission
EUROPEAN COMMISSIONENTERPRISE DIRECTORATE-GENERALSingle market : management & legislation for consumer goodsPharmaceuticals : regulatory framework and market authorisationsBrussels, 23 June 2004Ad Hoc GMP Inspections Services GroupGood Manufacturing PracticeProposed Addition (Annex 19) to the EU GMP GuideTitle:Reference Samples and Retention SamplesAgreed by ad hoc GMP inspectors services group April 2004 Released for public consultation 15 July 2004 Deadline for comments 15 January 2005 Final draft adopted by ad hoc GMP inspectors services groupAdopted by Pharmaceutical CommitteeDate for coming into operationNote:The new annex to the EU GMP Guide provides guidance on the taking and holding of refer-ence samples of starting materials, packaging materials and finished products as well as for retention samples of finished products. The annex provides definitions of the terms "refer-ence sample" and "retention sample", which are often incorrectly considered as synonyms. The guidance is wide ranging in scope and includes the case of multiple manufacturing sites, the position with respect to importers and what should happen when a manufacturing site ceases to operate. Updated guidance is also given on the size of reference samples and a con-sequential amendment will therefore be necessary to Chapter 6 section 14 of the GMP Guide to maintain consistency.PROPOSED ANNEX TO EC GUIDE TO GOOD MANUFACTURING PRACTICE REFERENCE SAMPLES AND RETENTION SAMPLES1. Scope1.1 This Annex to the Guide to Good Manufacturing Practice for Medicinal Products (“the Guide”) gives guidance on the taking and holding of reference samples of starting materials, packag-ing materials or finished products and retention samples of finished products.1.2 The guidance may also be applied to investigational medicinal products, subject to any differ-ence mentioned in Commission Directive 2003/94/EC and any more specific guidance in Annex 13 to the Guide.1.3 This annex also includes guidance on the taking of retention samples for parallel imported / distributed medicinal products.2. Principle2.1 Samples are retained to fulfil two purposes; firstly to provide a sample for analytical testing and secondly to provide a specimen of the fully finished product. Samples may therefore fall into two categories:Reference sample: a sample of a batch of starting material, packaging material or finished product which is stored for the purpose of being analysed should the need arise during the shelf life of the batch concerned. Where stability permits, reference samples from important intermediate stages of manufacture should also be kept. Examples include tablet cores and different stages of coating proc-esses.Retention sample: a sample of a fully packaged unit from a batch of finished product. It is stored for identification purposes. For example, presentation, packaging, labelling, summary of product charac-teristics / patient information leaflet, batch number, expiry date) should the need arise during the shelf life of the batch concerned.For finished products, in many instances the reference and retention samples will be presented identi-cally, i.e. as fully packaged units. In such circumstances, reference and retention samples may be re-garded as interchangeable.2.2 It is necessary for the manufacturer / importer / site of batch release, as appropriate, to keep reference and/or retention samples from each batch of finished product and, for the manufacturer to keep a reference sample from each delivery of a batch of starting material (subject to certain excep-tions – see3.2 below). Each packaging site should keep reference samples of each batch of primary and printed packaging materials.2.3 The reference and/or retention samples serve as a record of the batch of finished product or starting material and can be assessed in the event of, for example, a dosage form quality complaint, a query relating to compliance with the marketing authorisation, a labelling/packaging query, a pharma-covigilance report or a stability query.3. Duration of Storage3.1 Reference and retention samples from each batch of finished product should be retained for at least one year after the expiry date. The reference sample should be contained in its finished primary packaging or in packaging composed of the same material as the primary container in which the prod-uct is marketed (for veterinary medicinal products other than immunologicals, see also Annex 4, para-graphs 8 & 9).3.2 Unless a longer period is required under the law of the Member State of manufacture, samples of starting materials (other than solvents, gases or water used in the manufacturing process) shall be retained for at least two years after the release of product. That period may be shortened if the period of stability of the material, as indicated in the relevant specification, is shorter.4. Size of Reference and Retention Samples4.1 The reference sample should be of sufficient size to permit the carrying out, on two occasions, of the full analytical controls on the batch in accordance with the Marketing Authorisation File which has been assessed and approved by the relevant Competent Authority / Authorities. Any proposed exception to this should be justified to, and agreed with, the relevant competent authority.4.2 Where applicable, national requirements relating to the size of reference samples and, if nec-essary, retention samples, should be followed.4.3 Reference samples should be representative of the batch of starting material or finished prod-uct from which they are taken. Samples should include the most stressed part of a process (e.g. begin-ning or end of a process). Where a batch is packaged in two, or more, distinct packaging operations, at least one retention sample should be taken from each individual packaging operation. Any pro-posed exception to this should be justified to, and agreed with, the relevant competent authority.4.4 It should be ensured that all necessary analytical materials and equipment are still available, or are readily obtainable, in order to carry out all tests given in the specification until one year after ex-piry of the last batch manufactured. This applies also to analytical reference materials used in tests which have been superseded.5. StorageConditions5.1 Storage of reference/retention samples of finished products and reference samples of starting materials should be in accordance with the current version of the Note for Guidance on Declaration of Storage Conditions for Medicinal Products and Active Substances.5.2 Storage conditions should be in accordance with the marketing authorisation (e.g. refriger-ated storage where relevant).Agreements6. Written6.1 Where the marketing authorisation holder is not the same legal entity as the site(s) responsible for batch release within the EEA, the responsibility for taking and storage of reference/retention sam-ples should be defined in a written agreement between the two parties in accordance with Chapter 7 of the EC Guide to Good Manufacturing Practice. This applies also where any manufacturing or batch release activity is carried out at a site other than that with overall responsibility for the batch on the EEA market and the arrangements between each different site for the taking and keeping of reference and retention samples should be defined in a written agreement.6.2 The Qualified Person who releases a batch for sale should ensure that all relevant reference and retention samples are accessible at all reasonable times. Where necessary, the arrangements for such access should be defined in a written agreement.6.3 Where more than one site is involved in the manufacture of a finished product, the availability of written agreements is key to controlling the taking and location of reference and retention samples.7. Reference Samples – General Points7.1 Reference samples are for the purpose of analysis and, therefore, should be conveniently available to a laboratory with validated methodology. For starting materials and packaging materials, used for medicinal products manufactured within the EEA, these are the original site of manufacture and the site(s) of packaging, respectively. For finished products manufactured within the EEA, this is the original site of manufacture.7.2 For finished products manufactured by a third-country manufacturer and where an operational Mutual Recognition Agreement (MRA) is in place, the reference samples may be taken and stored at the third country site of manufacture. This should be covered in a written agreement (as referred to in section 6. above) between the importer/site of batch release and the third country manufacturer.7.3 For finished products manufactured by a third country manufacturer where no MRA is in place, reference samples should be taken and stored at a licensed manufacturer located within the EEA. These samples should be taken in accordance with written agreement(s) between all of the par-ties concerned. The samples should, preferably, be stored at the location where testing on importation has been performed.8. Retention Samples – General Points8.1 A retention sample should represent a batch of finished products as distributed in the EEA and may need to be examined in order to confirm non-technical attributes for compliance with the market-ing authorisation or EU legislation. Therefore, retention samples should in all cases be located within the EEA. These should preferably be stored at the site where the Qualified Person (QP) certifying the finished product batch is located.8.2 In accordance with 8.1 above, where an operational MRA is in place and reference samples are retained at a third country manufacturer (section 7.2 above), separate retention samples should be kept within the EEA.8.3 Retention samples should be stored at the premises of an authorised manufacturer in order to permit ready access by the Competent Authority.8.4 Where more than one manufacturing site within the EEA is involved in the manufacture im-portation/packaging/testing/batch release, as appropriate of a product, the responsibility for taking and storage of retention samples should be defined in a written agreement(s) between the parties con-cerned.9. Reference and Retention Samples for Parallel Imported/Parallel Distributed Products. 9.1 Where the packs are not opened, only the packaging material used needs to be retained, as there is no, or little, risk of product mix up.9.2 Where the packs are opened, for example, to replace the carton or patient information leaflet, then one retention sample, per packaging operation, containing the product should be taken, as there is a risk of product mix-up during the assembly process. It is important to be able to identify quickly who is responsible in the event of a mix-up (original manufacturer or parallel import assembler) as it would affect the extent of any resulting recall.10. Reference and Retention Samples in the Case of Closedown of a Manufacturer10.1 Where a manufacturer closes down and the manufacturing authorisation is surrendered, re-voked, or ceases to exist, it is probable that many unexpired batches of medicinal products manufac-tured by that manufacturer remain on the market. In order for those batches to remain on the market, the manufacturer should make detailed arrangements for transfer of reference and retention samples (and relevant GMP documentation) to an authorised storage site. The manufacturer should satisfy the Competent Authority that the arrangements for storage are satisfactory and that the samples can, if necessary, be readily accessed.10.2 If the manufacturer is not in a position to make the necessary arrangements this may be dele-gated to another manufacturer. The Marketing Authorisation holder (MAH) is responsible for such delegation and for the provision of all necessary information to the Competent Authority. In addition, the MAH should, in relation to the suitability of the proposed arrangements for storage of reference and retention samples, consult with the competent authority of each Member State in which any unex-pired batch has been placed on the market.10.3 These requirements apply also in the event of the closedown of a third country site of manu-facture. In such instances, the importer has a particular responsibility to ensure that satisfactory ar-rangements are put in place and that the competent authority/authorities is/are consulted.--------------------------------------------------------------------------------------------------------------- Consequential amendment to Chapter 6 section 14 of EU GMP Guide6.14 Reference samples from each batch of finished products should be retained till one yearafter the expiry date. Finished products should usually be kept in their final packaging and stored un-der the recommended conditions. Samples of starting materials (other than solvents, gases and water) should be retained for at least two years (1) after the release of the product if their stability allows. This period may be shortened if their stability, as mentioned in the relevant specification, is shorter. Refer-ence samples of materials and products should be of a size sufficient to permit the carrying out, on two occasions, of the full analytical controls on the batch in accordance with the Marketing Authorisation.(1) In Federal Republic of Germany, France, Belgium and Greece, samples of starting materials should be retained for as long as the corresponding finished product.。
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2019年越南河内国际制药医疗器械展览会
vietnam medipharm
展会介绍
展会时间:2019年05月08日
举办周期:一年一届
主办单位:越南卫生部（MINISTRY OF HEALTH）
展会地址:越南-河内-河内友谊文化宫Friendship Cultural Palace
展会详情
越南医药医疗展-VIETNAMMEDIPHARM是由越南卫生部主办，越南国家广告博览公司（VIETFAIR）承办的每年一届的定期在首都河内市举行的国际性展览会。
在越南卫生部的大力支持下，此展览会己成为越南国内医疗卫生领域目前规模最大，常年举办，影响力最强的专业性定期展会，也是东南亚地区知名的专业医疗展览会之一。
中国医药制药、医疗器械（越南）展览会同期举办以来，该展会作为越南医疗领域最专业的国际性展会同时也是中国医药、医疗企业开拓越南市场的独家“中国”品牌展，每年都吸引许多中国医药、医疗行业内的大企业参展。
展会展出总面积达7500多平方米，共设3个展厅全部满位。
展会吸引了来自越南、中国、韩国、印度、捷克、比利时、法国、日本、美国及中国台湾等15个国家及地区共350家企业参展。
展品范围
医疗:医疗产品：医疗设备及仪器、医用消耗品、医用敷料、手术设备、救护设备、诊断设备及用品、眼科仪器及设备、耳鼻喉科设备、牙科设备及用品、医用试剂及设备，医疗保健品及器材、医疗机构及实验室技术设备、医学信息及技术交流、美容仪器分析仪器：光学分析仪器、质谱仪、光谱仪、色谱仪、波谱仪、频谱仪、电化学分析仪器、射线分析仪器、气相色谱、液相色谱、热分析仪器、各式便携仪器、表面分析仪器、核分析仪器、元素分析仪器、过程分析仪器、成分分析仪器、注射分析仪器等其他通用分析仪器等；实验室设备：实验室仪器及设备、实验室自动化及配件、光学仪器设备、显微镜、光学影像处理、电子测量仪、万用表、示波仪、电子探针、电子模拟系统、单片机开发系统、图像分析处理系统、测试仪器与装置、校准装置、计量称重系统、化学试剂、实验室更新与改造技术、耗材及相关软件；生化领域：生化仪器、医用分析及诊断仪器、生物制药用仪器、药剂和诊断、DNA合成仪、酶标仪、细胞生物学仪器、生化工程设备、生物技术设备、发酵设备、提取设备、分离设备、过滤设备、灭菌装置、纯化设备、检测及控制设备、液体处理设备、洁净设备及各类耗材。
制药设备：药品的生产设备和技术、药品包装设备、药品包装材料、药品生产、清洗消毒配置系统成品药：各种中成药、西药、新药、特效药、生物制药、中草药原料药：各种原料药、化学制药、医药中间体家庭保健产品：保健药品食品，功能保健食品，保健器材，按摩器具，理疗产品等。