BRANDWOOD BIOMEDICAL securing your compliance www.brandwoodbiomedical.com China Update: What's New with CFDA Steven Wen Director China Operations and Senior Consultant 20 years experience in Chinese Medical Device and IVD regulatory affairs Previous Senior RA roles in for Medtronic, GE Healthcare, Bausch & Lomb and devices start-up
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BRANDWOODBIOMEDICALsecuring your compliancewww.brandwoodbiomedical.com
China Update: What's New with CFDA
Steven Wen
Director China Operations and Senior
Consultant
20 years experience in Chinese Medical
Device and IVD regulatory affairs
Previous Senior RA roles in for
Medtronic, GE Healthcare, Bausch &
Lomb and devices start-up
BRANDWOODBIOMEDICALsecuring your compliancewww.brandwoodbiomedical.com
BRANDWOOD:BIOMEDICALsecuring your compliance
Medical Devices and IVDs
Global Perspective
Highly Engaged
Highly Networked
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Agenda
Revision to Decree 650 - draft
Order 25 - GCP implementation
Second wave of clinical exemption list - draft
Prioritized device evaluation pathway - draft
Update of innovative pathway – draft
China ROHS 2.0
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The clinical study documents shall be properly kept and managed. The clinical institute shall keep such documents for 5 yeas after the study is completed, and the sponsor shall keep such documents for 10 years after the last manufactured device had been put into use
Article 91
The clinical institute shall keep the clinical study documents for 10 years after the study is completed. The sponsor shall keep the clinical study documents until the devices are not used in market any more.
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Critical changes in GCP Vs Order 5:Ethics and Records Requirements
Order 5 Order 25 - GCP
No Requirement
Chapter 5
Article 30 ~ 37
Detailed Ethics Review Requirements
Article 27
• Site Document Retention for 5 years after the study is completed
• Sponsor Document Retention for 10 years after the last manufactured device used.
Article 91
• Site Document Retention for 10 years after the study is completed.
• Sponsor Document Retention until the devices are no longer used in the market
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3 Paths for Submitting Clinical Evidence
In Class II & III exemption list
Justify that device matches description
in exemption list
Comparison to a substantially
equivalent device
Not in exemption list but Sufficient Clinical
evidence compared to predicate
device
Clinical Evaluation Report with detailed
comparison to substantially
equivalent predicate device
Not in exemption list, Insufficient clinical
evidence compared to predicate
device
In-China Clinical Trial
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Exemption list of clinical study
Wave Class II devices Class III devices Effective date
Wave 1
488 79 Oct 1, 2014
Wave 2 ( Draft ) 259 93TBD ( draft released
on May 20, 2016 )
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Prioritized Device evaluation pathway – DraftEligibility Criteria (Meet Any One)
State R&D Priority Area
Clinical Priority Area
• Rare Disease
• Cancer
• Paediatrics
• Geriatrics
• Unmet clinical need
• Urgent clinical need with no equivalent device approved in China
Others to be determined by CFDA
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File request with CFDAregistration submission
CFDA judgment in 5 working days
CFDA monthly review
State R&D Priority
Area
Clinical Priority
Area
Prioritized Device evaluation pathway – DraftApplication Process
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Innovator Devices Fast Track
Single Contact Person to Manage Review
Advance Feedback from Test Centre
Classification category is decided in parallel with technical review
Special Review Team appointed by Office of Innovative Devices
Priority ProcessingChina Patent
+ Design Controls
and DHF
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Comparison: Innovative and Priority Pathways
•
Innovative pathway Prioritized pathway
Conditions• Patent registration in China
• Innovative technology with clinical
advantage
• State level R & D project
• Clinical urgency
• No equivalent device in China
• Clinical advantage
Request procedure Prior to registration submission With registration submission
CFDA Decision > 40 working days• State level R & D – 5 working days
• Clinical Priority – monthly review
CFDA pre-consultation Yes No
CFDA Prioritized review Yes Yes
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Current status of innovative pathway March 2014 – July 2016
•
Local device,
63, 94%
Import device,
4, 6%
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China ROHS 2.0 - Background
Promulgated by multiple government departments jointly
Replaced China ROHS 1.0 published in 2006.
China’s Ministry of Information & Industry ( MII );
National Development and Reform Commission ( NDRC);
Ministry of Science & Technology ( MST);
Ministry of Finance ( MOF);
Ministry of Environment Protection ( MEP );
Ministry of Commerce ( MOC ),
General Administration of Customs ( GAC)
General Administration of Quality Supervision, Inspection and Quarantine ( AQSIQ)
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China ROHS 2.0 - Definitions
Restriction of Hazardous Substances in Electrical & Electronic Products
ROHS
Equipment and ancillary products which operate on electric current or electromagnetic field, or to generate, transmit or measure electric current or electromagnetic field, with rated working voltage under 1,500V DC or 1,000V AC.
Equipment for electricity production, transmission or distribution are excepted.
Electrical & Electronic Products
Lead and its compounds (Pb)
Mercury and its compounds (Hg)
Cadmium and its compounds (Cd)
Chromium VI and its compounds (Cr 6+)
Poly-brominated Biphenyl (PBBs)
Poly-brominated diphenyl ethers (PBDEs)
Others to be announced later
Hazardous substance
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China ROHS 2.0 – Content Limit
A product list for mandatory compliance will be published shortly. The hazardous substance in enlisted product must be lower than below limits:
Hazardous substance Content limit ( %)
Pb 0.1
Cd 0.01
Hg 0.1
Cr6+ 0.1
PBBs 0.1
PBDEs 0.1
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China RoHs 2.0 – Labeling requirements
Hazardous substances are below the limit (or absent).
Hazardous substance contents above the limits
The number represents the years that the product can be safely used
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China ROHS 2.0 – Labeling requirements
In case of orange logo, the user’s manual needs to include a table as below to indicate the name and hazardous substance contained in each part.
Parts Hazardous substance contents ( “O” or “X” in each cell)Pb Hg Cd Cr6+ PBBs PBDEs
Part 1 O O O O O XPart 2 X O O O O XPart 3 O X O O O O
…
O: Content of hazardous substance in any homogenous materials of this part is below the limit set by GB/T 26572-2011
X: Content of this hazardous substance in at least one of the homogenous materials of this part exceeds the limit set by GB/T 26572-2011 (the supplier shall explain the technical reasons of “X” here)
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China RoHs 2.0 – Relevant standards
Content Limit
GB/T 26572-2011
Requirements of concentration limits for
certain restricted substances in electrical and
electronic products
Labeling Requirements
SJ/T 11364-2014 Marking for the restriction of the use of hazardous substance in electrical and electronic
product
Testing Method
GB/T 26125-2011 Electrical and electronic products—
chromium(VI) in electrical and electronic products –
Atomic fluorescence spectrometry
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Comparison to China RoHs 1.0
China RoHs 2.0 China RoHs 1.0
Scope Electrical & Electronic products Electronic Information Products
Mandatory
compliance listYes No
Inspection product list No Yes
Labeling requirement Logo + table Logo + table
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Comparison to EU RoHs requirements
China RoHs 2.0 EU RoHs
Content limitProduct in mandatory compliance list must be lower than the limit
All products must be lower than limit
Exemption provision
No Yes
Compliance evidence
• Design and manufacturing control documents
• Labeling information ( Logo + content table in user manual )
• Design and manufacturing control document
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Actions for suppliers
Suppliers of Electrical & Electronic products shall collect the hazardous substance content information from upstream suppliers of parts.
Products produced after July 1, 2016 must bear the green or orange ROHS logo, and include a hazardous substance content table in user manual for orange logo.
Once the mandatory compliance list is published (the date is unknown by now), suppliers of enlisted products shall take measures to reduce the hazardous substance down to the limit then change to green logo, if necessary.
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