latest update china regulations by s. huang - qserve group (qserve conference 2013)

| 2013 |Copyright Qserve Group B.V.

The regulatory road to market The regulatory road to market

[China] Regulations Update

Q s e r v e C o n f e r e n c e 1 8 - 1 9 N o v e m b e r 2 0 1 3

P u r m e r e n d – G r e a t e r A m s t e r d a m


China Regulation Update

1 Regulatory Review

3 Advice

2 Recent Changes


1. Order 276(April 2000) State Council

• Regulation on supervision and administration of medical devices

• Fundamental law governing the MD industry

2. Guidance No.16 (August 2004) CFDA

• Provisions on the administration of registration of medical devices

3. Different?

• Case study-uncertified imported products

• Clause 11 vs. annex 9

Regulations


Submission Procedure Product

Classification

Design the procedure and draft the standards

Prepare application Package（technical file, dossier, application form etc)

Testing Center Document Package

translation and filing

CFDA admin Check and start the process

CFDA Evaluation Center（CMDE）Tech Evaluation

Amendment

SFDA admin Approval

SFDA Certificate Issue

Obtain the Certificate

Testing Report

Question the document

Clinical Trial (if needed) Clinical Report


CFDA vs. Provincial Level FDA

• Provincial FDA issue registration license(I,II domestic

products) and license renewal

• License is valid for 4 years

• Provincial FDA issue MD production permits

• Permit is valid for 5 years

• **Domestic III and all imported medical devices must

be registered with CFDA prior to selling in China



1 Regulatory Review

3 Advice

2 Recent Changes


Recent Changes on Medical Device

1. SFDA-CFDA organization changes

• Effective Date: March 22, 2013

• “Chief” added

• Streamline control(Pre-market vs. Post-market)

• More qualified staff

• More power vs. more responsibility

• Legislation(to be released)

The website still www.sda.gov.cn



2. Medical devices removed from CCC catalogue

• Effective Date: April 23, 2013

• What is CCC?

8 devices CCC

(Medical X-ray Diagnostic Equipment, Hemodialysis Equipment,

Hollow Fiber Dialyzer, Extracorporeal Blood Circuit For Blood

Purification Equipment, Artificial Heart-Lung Machine,

Electrocardiographs, Implantable Cardiac Pacemakers and

Rubber Condoms )

• Existing certificate?

• Applicant in transition and fees?


3. CFDA approval procedures for amendment

• Effective Date: October 1, 2013

• Change/amendment of some domestic III and IVD III

• Quality system inspection of certain III(Cardiac pacemakers,

artificial heart valves, stents and catheters, disposable plastic

blood bags, animal origin allogeneic medical devices)

• Report data back to CFDA every half month

• Application before 30th Sept 2013?




4. Determination of Classifications

• Effective Date: March 28, 2013

• Uncertain or new medical devices are need to be classified

• File online

• Domestic product-Provincial FDA vs CFDA

• Imported product-standard management center

- Chinese is the only accepted language

• Drug-device combination product?

• *CMDE



Classification







Amendment

SFDA admin Approval



Testing Report





Feedback before 1 June Feedback after 1 June

submit the supplement, one

more chance(60 working days)

submit supplement, a T/C notice (15working days)

applied extension (60 days from 1 June)

once extension chance( total 120)

5. Registration supplementary documents review time

• Effective Date: June 1, 2013

***Otherwise, application will be terminated

***Cannot submit within half a year



Classification







Amendment

SFDA admin Approval



Testing Report





6. Labeling Requirement

• Effective Date: April 1, 2013

• Guidance on MD manual, labeling, and packing.

No. 10.(June 2004)

No penalty

• Guidance on labeling, and packing for imported devices.

No. 634(2008)

• Updated guidance on labeling, and packing for imported devices

No. 280(Sept. 2012)---effective on April 2013


Example



7. Improved AE report system

• Effective Date: July 17 2013

• AE monitoring and supervision regulation(trial)

• 3 years network establishment

• Coverage (III manufacturing , III distribution. AA hospital and

above)

• Monitoring office, Staffing ,equipment, informatization (online

report)


Surveillance and Recall Guidance of Medical Device(No. 425)- May 2011 • Medical device manufacturers must report adverse events which

causes death within 5 days.

• Report the events which caused or possibly cause severe injury or

death within 15 days.

• Medical device manufacturers should establish internal adverse

events monitoring systems and appoint people to keep records

and report adverse events.

• The post market scrutiny of medical devices will be amended

further.



8. Electromagnetic compatibility (IEC60601-1-2)

Effective Date: January 1, 2014(III) vs January 1, 2015(II)



1 Regulatory Review

3 Advice

2 Recent Changes


1. Application data confusion, unable to evaluate safety and

effectiveness

• Case study: Change of all the names

• Clinical data

2. Qualification Verification

• Case study: ISO

• Test house

Case study-not in compliance


How to Speed Up


1. Fast lane vs. Self rescue

2. Experience vs. Attitude

3. Communication

4. Flexible way of doing business

How to Speed Up


Thank you!

谢谢

S t e p h a n i e H u a n g C h i n a R e p r e s e n t a t i v e , Q s e r v e G r o u p C h i n a S t e p h a n i e . h u a n g @ q s e r v e g r o u p . c o m

www.qservegroup.com Qserve Consultancy B.V.

Asterweg 19 D12 1031 DL Amsterdam

The Netherlands T +31 (0)20 78 82 630

E [email protected]

latest update china regulations by s. huang - qserve group (qserve conference 2013)

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