HCE China Medical Newsletter: June Issue Go back »

2009-07-29 | Beijing, Shanghai

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Contact us:

COCIR China Business Manager Ms. Yujie Bao at china@cocir.org  for more information

Editor’s Note

Dear readers,

This is our first newsletter focusing exclusively on Chinese medical device issues that shape the general business environment for our members operating in China. The China Medical Newsletter will keep you abreast of the status of relevant Chinese laws and regulations, as well as China’s rapidly growing medical industry.

Laws, Regulations and Notices

The State Food and Drug Administration (SFDA)’s Center for Medical Device Evaluation (CMDE) published a call for comments on IVD Analysis and Performance Evaluation Guidelines, June 1, 2009.

(Click here to download the document in Chinese))

SFDA sets out the principles and procedures for the coverage of products included in the quality management system of in-vitro diagnostic reagents, June 15 2009

(See the news in English please click here and to view the full text in Chinese, please click here

SFDA publishes notice on issuing the guidance on the technical review of the registration of the B-type ultrasonic diagnostic equipment (Class II) and multi-parameter monitoring equipment (Class II)

(To download the documents in Chinese please click here. Username and login password is needed to download the English translation of this notice from our website)

SFDA publishes Order 68 concerning Trans-provincial Merger of Medical Device Enterprises, released on June 3 by SFDA

(To see the original posting on SFDA’s website in Chinese please click here. Username and login password is needed to download the English translation of this notice from our website)

SFDA releases list of officials in its Healthcare Reform Leader Group, released on May 31, 2009 by SFDA

(To see the original posting on SFDA’s website, please click here)

Industry News

 Six Public service Projects of the Healthcare Reform to be started in Advance in the year 2009, released on June 18, 2009 by Gov.cn

(See full text in Chinese please click here)

MOHRSS: Provide institutional guarantee for all our people to enjoy their rights to medical care

(See full text in Chinese please click here)

SFDA held video conference deploying supervision of drugs and medical devices used against A (H1N1)flu, released on June 23, 2009 by SFDA

(See full text in English please click here)

Preliminary session about setting up the strategic alliances of the technological innovation of the laser medical devices was held in Wuhan, released on June 17, 2009 by MOST

(See full text in Chinese please click here)

Beijing to add new hospital against A(H1N1) flu, released on June 15 by China Daily

(See full text in English please click here)

 European Chamber Annual Business Confidence Survey launched on June 29, 2009

(To download the press release, its Chinese version and the PowerPoint Presentation on the press conference, please click here. Membership is required to receive the electronic copies of the 2009 BCS)

Industry Standard for Refurbished Medical Equipment during COCIR 50th Anniversary on June 18, 2009

(See the detailed press release and download relevant documents please click here )

Lobby Activities

The monthly Healthcare Equipment Working Group meeting was held on June 1, 2009 in the EUCCC Beijing Office. Please refer to the meeting agenda below for details and click here to download relevant meeting minutes and presentations.

Agenda:

1. Debriefing on Position Paper presentations to SFDA Commissioner Shao Mingli (April), SAIC Vice Minister Fu Shuangjian(May) and SCLAO Vice Minister Yuan Shuhong (May) 

2. Discussion on two Draft regulations for Comments: SFDA amendment draft on medical device registration and AQSIQ Draft on Defective Product Recall

3.   Discussion on 2nd draft of ’09 EUCCC HCE Position Paper

Comments from members of the Working Group on CMDE’s IVD Analysis and Performance Evaluation Guidelines have been submitted to CMDE. Username and password is needed to download the comments from the EUCCC website.

Events, Seminars and Workshops

A symposium was organized by Beijing Investment Bureau on China’s Healthcare reform, featuring guest speaker MOH Vice Minister Zhang Mao this Wednesday, 3 June, in Beijing Xiyuan Hotel. Several member companies sent representatives to this invitation-only event via the European Chamber.

 The EU-China Workshop on Application of Standardisation in China was held in the afternoon of 26th and whole day 27th May at the Renaissance Beijing Hotel. Aiming to provide EU industry represented in China with a practical understanding of the standards making process in China, the workshop gave a through introduction of the structure of Chinese standardization and its links to Conformity Assessment and IPR regime. Furthermore, the training also introduced the main stakeholder in Chinese standardisation, establishment of TC and its participants, as well as examples of strategies adopted by the Chinese industry engaged in standards drafting. Many members

The presentation from the EU-China Workshop on Application of Standardisation in China is now ready for download. Please click here to download all presentations bundled in one PDF file.