Considering the particularity of IVD products in the family of medical devices, the European Union Chamber of Commerce (EUCCC) Healthcare Equipment Working Group (HCE WG) had agreed on the proposal of establishing an IVD Sub-Group.

The Sub-Group aims to create a platform for members specialised in IVD to network, exchange information and discuss issues particularly relevant to the IVD industry. The meeting will be chaired by the HCE WG Vice Chairman Mr. Davey Han.

We cordially invite you to attend the IVD Sub-Group kick-off meeting held at European Chamber in Beijing on Wednesday, 20th February from 9.00 to 11.00 am.

The objective of this meeting is to get to know each other and understand where the EU Chamber can help the industry. In this regards we hope to identify issues, be able to priorities these and think of possible lobbying strategies jointly with you.

AGENDA
09.00 - 09.10: Introduction of EUCCC HCE WG and the cooperation with Eucomed and COCIR
09.10 - 09.35: HCE WG action review and priorities for 2008
09.35 - 10.00: Development of IVD Regulations in 2007
10.00 - 10.50: IVD specific priorities and strategies 2008
10.50 - 11.00: AOB

Please confirm your attendance with Ms Vivian Cai at vcai@euccc.com.cn. Please kindly also inform industry colleagues of yours that might be interested but we could not include in this e-mail.

We welcome your comments and suggestions prior to our meeting. Please send an e-mail to Mr. David Lee at dlee@euccc.com.cn and Mr. Maurizio Andreano at mandreano@euccc.com.cn before February 14th, 2007, Thursday.

We are looking forward to seeing you soon.

Best regards,

David and Maurizio

Event review

Health Equipment - IVD Sub Working Group Meeting
Wednessday, 20th February 2008, 9:00a.m.

Dear Industry Representative,

Thank you once more for you interest expressed in working with the EU Chamber of Commerce in China (EUCCC) and the lively discussion during our Kick-Off meeting.

Please find attached meeting minutes and prepared presentation for your reference. Please mark in your calenders the next IVD Sub-Group meeting will be held on Wednesday, 26th March 2008, 9-11am. Please feel free to e-mail us prior to the meeting any further ideas and comments on the priority list or possible actions you would like to see executed.

As explained The EU Chamber is ready to work with you and address the particular concerns of the IVD industry to the relevant Chinese and European authorities. This will complete and strengthen the already existing Healthcare Equipment Working Group (HCE WG) and give you a platform to exchange information and jointly lobby.

A prerequisite however is the subscription to the EUCCC in order to become a corporate member. I have attached our membership form and policy for your reference and invite you to contact directly my colleague Ms Maya de Filippo at mdefilippo@euccc.com.cn or David Lee and Maurizio Andreano for any question. Be aware that your company becomes a member as a whole meaning you and your colleagues e.g. in Beijing can access not only the Healthcare Equipment WG but many others and also any Chamber events.

We are looking forward to welcoming you as our new member in March.

Best regards,

David and Maurizio

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For any further information about the EUCCC Healthcare Equipment Working Group or general inquiries such as Membership with the European Chamber, please do not hesitate to contact Mr. Maurizio Andreano at mandreano@euccc.com.cn or Mr. David Lee at dlee@euccc.com.cn , Tel: 010 - 6462 2066

Agenda

09.00 - 09.10: Introduction of EUCCC HCE WG and the cooperation with

Eucomed and COCIR

09.10 - 09.35: HCE WG action review and priorities for 2008

09.35 - 10.00: Development of IVD Regulations in 2007

10.00 - 10.50: IVD specific priorities and strategies 2008

Attendees please click here

Discussion Points

Introductory

For agenda point 1, 2 and 3 please view the attached two presentations.

It was highlighted that 2007 was surely a difficult year for SFDA with many changes of positions

and tighten control efforts. It was also an important year for IVD and a good chance has been

missed by the industry to voice up their concerns in a more systematic manner e.g. through the

EU Chamber or other bodies. Nevertheless, it is seen being not too late to engage the authorities

this year and successfully influence the implementation of the regulation.

IVD specific priorities and strategies 2008

1. General comments on new IVD regulations (effective since 1st June 2007)

• Although the new IVD regulation should make it easier the contrary is happening. The

administrative efficiency is low and sometimes could be described as red tape.

• China IVD regulation adopted much from the EU IVDD, however regulators struggle with

its implementation.

• Issues of interpretation and lack of understanding from officials. In most cases it is not

clear what the officer in charge expects – seems to be a trial for everyone with no clear

answers to be expected from official side. Industry should jointly approach SFDA and explain

what is reasonable and feasible. Challenge!

• Need to share more global experiences with SFDA, in particular Technical Evaluation

Centre.

• The industry experiences an increase in merger & acquisitions and companies changing

names, location, etc. The administrative system is often not able to handle this in a most

efficient manner or granting grace periods. Generally a new round of company registration

has to be launched.

• Re-registration is relatively burdensome, since for every slight product change to the

thousands of products produced a company should submit a re-registration.

• Filing system varies from company to company or sometimes even within one

organization. This confuses officers who in many cases have little experience and simply try

to compare forms. This often triggers mistrust and an endless series of additional inquiries.

• In the past roundtables have been held, however results are little.

• Benefits of streamlining approval process, adopting international practice and guidelines,

etc. for all industry players in China should be communicated more to the government.

• More trust building necessary between enterprises and authorities.

2. Labeling

• Is described as cumbersome and expensive with no additional safety benefit.

Supporting regulation missing.

• Subtopics include acceptation of e-labeling for application, exemption or grace period,

immediate container labeling.

3. (Local) clinical trial

• Review panel with limited experience and missing guidelines on report reviewing.

• Companies are afraid of doing trials first

• Expert panel on clinical trial

4. Tendering

• As for other medical products also IVD are seriously affected by public tender since not

transparent and consistent with regards to criteria, technical requirements and

procedure. Beijing authorities serve often as a tendering model and affect other

provinces. Cooperate and dialogue with BJ Health Bureau is necessary.

Results of WG discussion

• What are the Priorities (no ranking)

1) Clinical trials (criteria, expert panel, ‘new product’ to China)

2) Tendering (BJHB)

3) Labeling (exemption, e-Labeling, immediate container)

4) Notification in case of non-material changes (e.g. M&A)

5) Training (Technical Evaluation Centre, filing system )

6) Standardization incl. metrology

• Who are the Stakeholders

1) SFDA

2) Provincial FDAs including Beijing & Shanghai

3) SFDA, Medical Device Technical Evaluation Centre

4) MoH (including BJ HB)

5) CAMDI (check for cooperation on mutual topics)

6) MD Testing Institutions (Beijing, Shanghai)

• What is our Strategy

tbd during next meeting on March 26, 9-11am

The next meeting will be held on Wednesday, 26th March from 9-11am at the EUCCC offices in

Beijing

1. See the IVD law development in 2007 please click here

2. See the Presentation for IVD sub group kick-off meeting please click here

3. Download Membership Application Form 2008 please click here

4. See membership pricing please click here

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