HCE China Medical Newsletter: July Issue Go back »

2009-08-05 | Beijing, Shanghai

CONTENT:

Laws, Regulations and Notices

Industry News

Lobby Activities

Upcoming Events

>> EUCCC Healthcare Equipment Working Group in Beijing and Shanghai

>> EUCCC Home

Link to partner associations:

>> COCIR Home

>> Eucomed Home

Contact us:

Beijing: Ms. Yujie Bao at ybao@euccc.com.cn  (COCIR Business Manager)

Shanghai: Ms. Penny Zhao at yzhao@euccc.com.cn   (Eucomed Business Manager)

Disclaimer: This newsletter is for informational purposes only among European Chamber Healthcare Equipment Working Group members and should not be construed as business or legal advice on any specific facts or circumstances. We will not be responsible for the accuracy and completeness of the information provided in the newsletter and the European Chamber accepts no legal liability for errors or omissions.

Editor’s Note

Dear readers,

This is our first newsletter focusing exclusively on medical device related issues that shape the general business environment for our members operating in China. The Healthcare Equipment (HCE) Monthly will keep you abreast of the status of relevant Chinese laws and regulations, as well as China’s rapidly growing medical device industry.  Please kindly send your feedback to hce@euccc.com.cn, so we can serve you better and optimize our resources in the most efficient way. Login name and password are sometimes required to download materials from the Members Only section.

I. Laws, Regulations and Notices (by date of release)

SFDA, Centre for Medical Device Evaluation: Notice on Few Technical Issues Concerning Registration and Declaration of the Passive Implantable Medical Device Commodity, June 30, 2009.

国家食品药品监督管理局医疗器械技术审评中心: 关于无源植入性医疗器械产品注册申报若干技术问题的说明

(To view the notice in Chinese please click here)

SFDA: Notice on Promoting the Administrative Examination and System Reform of the 2009 Food and Drug Supervision System, June 30, 2009.

国家食品药品监督管理局: 关于2009年食品药品监管系统推进行政审批制度改革工作的通知

(To view the notice in Chinese please click here)

MOH: Notice on Promoting the New Type of Rural Cooperative Medical Care System in the 2nd half of 2009, June 30, 2009.

卫生部办公厅: 关于做好2009年下半年新型农村合作医疗工作的通知

(To view the notice in Chinese please click here)

AQSIQ: Revised China Compulsory Products Certification Management Regulation [AQSIQ Order 117], July 3, 2009.

国家质量监督检验检疫总局: 第117号令《强制性产品认证管理规定》

(To view the regulation in Chinese, please click here. Username and login password is needed to access the unofficial comparison between newly promulgated Order 117 and Order 5 released in 2001 from our website, click here)

SFDA: Notice on Carrying Out A Comprehensive Inspection on the Supervision and Examination of Drugs and Medical Devices for Prevention and Better Control of H1N1 Influenza, July 6, 2009.

国家食品药品监督管理局: 关于对甲型H1N1流感防控药品医疗器械监督检查工作开展全面督查的通知

(To view in Chinese please click here)

MOH: Service Regulation of the Ministry of Healthcare, July 21, 2009.

卫生部: 关于印发《卫生部工作规则》的通知

(To view the regulation in Chinese please click here)

State Council Legislative Affairs Office: Notice on Issuing the Arrangement of the Five Key Points in 2009 Medical and Healthcare System Reform, July 22, 2009.

国务院办公厅: 关于印发医药卫生体制五项重点改革2009年工作安排的通知

(To view the notice in Chinese please click here)

MOH: Issuing of “Radioactive Tumor Etiology Criteria” and two National Compulsory Occupational Health Standards

卫生部:《放射性肿瘤病因判断标准》等2项强制性国家职业卫生标准发布

(To view the notice in Chinese please click here)

II. Industry News (by date of release)

MOH and All-China Women Federation: Notice on Management Programme of Rural Women’s “Two Cancer” Examination Items, June 30, 2009.

卫生部、全国妇联关于印发《农村妇女“两癌”检查项目管理方案》的通知

(To view the news in Chinese please click here)

National People’s Congress Standing Committee: Announcement of the 2009 Legislative Work Plan on July 3, 2009.

全国人大常委会2009年立法工作计划

(To view the work plan in Chinese, please click here. Username and login password is needed to access the unofficial English translation of this document courtesy of the European Chamber from our website, click here)

MOF: Central Government Will Allocate 10.4 Billion RMB as 2009 Basic Public Health Services Funding, July 6, 2009.

中央财政下拨2009年基本公共卫生服务补助资金104亿元

(To view in Chinese please click here)

MOF: Release of the 2008 Central Government Final Accounts Report, July 7, 2009.

财政部公布《关于2008年中央决算的报告》

(To view in Chinese please click here)

Gov: Vice Chairman of the NPC Standing Committee Lu Yongxiang reiterates government’s commitment in ensuring all people benefit from the proliferation of public education and basic healthcare system

July 10, 2009.

路甬祥：保证公办教育和基本医疗惠及全体人民

(To view in Chinese please click here)

China National Radio: MOH will tighten control on medical devices of clinical use, July 12, 2009.
中央人民广播电台：卫生部 - 医疗器械临床使用将收紧关口

(To view in Chinese please click here)

MOH, MOF & National Population and Family Planning Commission:  Opinion on Facilitating the Equalisation of the Preliminary Public Health Service, July 14, 2009.

卫生部、财政部、国家人口计生委联合印发《关于促进基本公共卫生服务逐步均等化的意见》

(To view in Chinese please click here)

GOV: Vice Chairman of SFDA Bian Zhen-Jia attended national Drug and Medical Devices Forum and remarked for strengthening the testing and inspection work under new system, July 27, 2009.

边振甲副局长出席2009年全国药品医疗器械检验检测工作座谈会　要求：“以能力建设为核心 — 全面加强新体制下检验检测工作”

(To view in Chinese please click here)

MOH: A Budget Working Committee was set up and held its inauguration meeting, July 27, 2009.

卫生部成立预算工作委员会并召开第一次全体会议

(To view in Chinese please click here)

III. Lobby Activities

Ÿ           Roundtable with MoH IHECC

On July 22, 2009, delegation of more than 30 industry representatives from the Healthcare Equipment Working Group held a roundtable meeting with the Director of MOH’s International Health Exchange Cooperation Centre. A list of questions on centralised tendering and procurement for medical devices were raised during the meeting. Please go to our website (click here for meeting minutes and here for brief news) for more information about this event.

Ÿ           2009 HCE Working Group Position Paper to be Finalized

The final draft of Healthcare Equipment Working Group Position Paper in Chinese was circulated to all members on July 27, 2009 for final comment. Please send your comments to Ms. Catherine Chou at cchou@euccc.com.cn by COB August 4.

IV. Upcoming Events, Seminars and Meetings

Seminar on Healthcare Reform in China: Chances and Challenges

Ÿ           The European Chamber is delighted to invite you to an afternoon seminar on China’s new Healthcare Reform at Kempinski Hotel Beijing on Wednesday 5th August. At this seminar, our guest specialists will share with you a deep insight into China's new blueprint to a universal healthcare system by highlighting its opportunities and challenges to foreign enterprises and by giving key information to attendees to drive successful strategies and operations in developing business in China.

To register for the event, please click here.