medical device management in china and latest regulatory updates_edwin
TRANSCRIPT
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Medical Device Management in China and Latest Regulatory updates
23th April 2015, Michelangelo Hotel, Milan, Italy Edwin Wen(温健麟 ), SP&BD Manager of CIRS Email: [email protected]
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目录 CONTENTS
Overview of Medical Device Management in China
Latest Regulatory updates
Practical Advice for Foreign Devices Entering
into China Market
Resources
Our Sectors | CIRS
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Table of Contents
Overview of Medical Devices Management in China- Definition of Medical Device in China
- Risk Based Classification
- China Competent Authorities
- Governing principles
- Full life cycle supervision and management
- Medical device Management Policies
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1. Definition of Medical Device in China
Any instrument, apparatus, appliance, material, in vitro diagnostic reagents and calibration substances and other similar substances and related articles, including the needed computer software. Its main effectiveness is achieved via physics ways and so on. It does not achieve its principal action in or on the human body by means of pharmacology, immunology or metabolism, but which may be assisted in its function by such means; the use of which is to achieve the following intended objectives:Diagnosis, prevention, monitoring, treatment or alleviation of disease;Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap conditions;Investigation, replacement or modification for anatomy or a physiological process;Life support or maintenance;Control of conception；Offer information for medical or diagnosis purpose via inspecting the human samples.
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2. Risk based Classification
Risk
Lower
Higher
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3. China Competent Authorities
China competent authorities Supervised and administrated Items
China Food and Drug Administration (CFDA) and
the provincial food and drug administration bureau
Medical device registration and evaluation,
manufacturing and distributing license, quality
assurance. (Full life-cycle supervising)
The National Health and Family Planning
Commission of PRC (NHFPC)
Safety and hygiene management of medical
devices used in the medical institutes. (Post-market
supervising)
General Administration of Quality Supervision,
Inspection and Quarantine (AQSIQ) and the
provincial Entry-Exit Inspection and Quarantine
Bureau (CIQ)
Certification and accreditation of quality system,
and supervision on the import or export activities
of medical devices with its package.
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4. Governing principles
China Food and Drug Administration (CFDA) Provincial food and drug administration bureau Municipal food and drug administration bureau County level food and drug administration authorities
Center for Medical Device Evaluation (CMDE) National Center for Adverse Drug Reactions Monitoring Medical Device Quality Testing Centers The Technical Committee for Medical Device Standardization
Medical device classification Strictly supervised medical devices Decentralized Administration
Safety monitored by local authorities Quality management system Daily supervised and administrated
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4. Governing principles (continued)
CFDA Provincial FDA
Municipal FDA
Evaluation and approval of domestic class III medical devices and overseas medical devices (Class I, II and III medical devices)
-Evaluation and approval of domestic class II medical devices- Approval of domestic class II and III medical device manufacturing
- Domestic class I medical devices recording and manufacturing recording- Approval of medical device distributing
Decentralized Administration
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5. Full life cycle supervision and management
Quality Management and Risk Management
Classification, Nomenclature, Standards, Technical requirements, Clinical study, risk assessment, label, instructions, inspection, R&D
Submission, Formal review, technical evaluation, administrative approval, safety and effectiveness evaluation.
Manufacturing license, routine inspection, QMS auditing
Distributing license, internet trading, GSP, Advertisement, Customs clearance.
Routine inspected by CFDA and NHFPC (National Health and Family Planning Commission of the PRC )
Adverse event monitoring, recall, re-evaluation, withdraw the registration
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6. Medical device Management Policies
National health concerned laws
Decree No. 650- The Regulations for the Supervision and Administration of Medical Devices
-Administrative Measures for Medical Device Registration （ CFDA order No. 4）-Administrative Measures for the Registration of In Vitro Diagnostic Reagents(CFDA order No. 5)-Administrative Rules for the Instructions and Labels of Medical Devices (CFDA order No.6)-- Administrative Measures for the Supervision of Medical Device Manufacturing(CFDA order No.7)- Administrative Measures for the Supervision of distribution of Medical Devices (CFDA order No.8)
Requirements and Introductions of Registration Declaration Data of Medical Instruments (CFDA notice No. 43)
constitution
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6. Medical device management polices (Continued)
Category Regulations
Main Enabling Legislation - The Regulations for the Supervision and Administration of Medical Devices (Decree No. 650)
Registration
-Administrative Measures for Medical Device Registration- Administrative Measures for the Registration of In Vitro Diagnostic Reagents- Special Review and Approval Procedure for Innovative Medical Devices (interim)- The Guideline on Preparation of Medical Device Technical Requirements
Nomenclature & Classification
- The Provisions of Medical Device Nomenclature- The Provisions for Medical Device Classification
Labeling - Administrative Rules for the Instructions and Labels of Medical Devices
Clinical trail-GCP-The Quality Management Practices for Medical Device Clinical Trial-The Technical Guidelines for In Vitro Diagnostic Reagents Clinical Trial- Technical guiding principle on medical devices clinical evaluation
Adverse Event MonitoringRe-evaluation
-The Guide for Medical Device Adverse Event Monitoring-The Requirements for Medical Device Adverse Event Monitoring and Re-evaluation (interim)- The Provisions for Medical Device Recall (interim)
Import/Export The Management Measures for Imported Medical Device Inspection and Supervision
Manufacture-Administrative Measures for the Supervision of Medical Device Manufacturing- The guide on supplier audit for Medical Device Manufacturing Enterprise
DistributeUse
-Administrative Measures for the Supervision of distribution of Medical Devices- Administrative Measures for the Supervision of distribution of food and drug on internet- Administrative Measures for the Supervision of Medical Device Use
QMS-GMP-The Quality Management Practices for Medical Device Manufacturing- GSP-The Quality Management Practices for Medical Device Distributing - GUP-The Quality Management Practices for Medical Device Use
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Table of Contents
Latest Regulatory updates- Statistics for Medical Device Regulatory Compliance
- Glance on Regulatory Updates
- Significant Changes to Clinical Trial
- Innovative Medical Devices Registration and Approval
- Amendments to Medical Device Registration
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1. Statistics for Medical Device Regulatory Compliance
Statistics of medical device registration in China
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1. Statistics for Medical Device Regulatory Compliance (Continued)
Item Statistics Distribution
Imported medical device
Registration Certificates 34,650
Legal Representative(Registrant)
2,447
Domestic medical device
Registration Certificates 93,582
Legal Representative(Registrant)
14,723
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1. Statistics for Medical Device Regulatory Compliance (Continued)
Medical device manufacturer and distributor distribution in China
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1. Statistics for Medical Device Regulatory Compliance (Continued) Top 10 list for medical device industry in China
No.
Number of registration certificate(by manufacturing area)
Number of registration certificate (by classification)
Domestic (Province) Imported(Country) Domestic Imported
1 Jiangsu USA 6840 6840
2 Shanghai Germany 6864 6822
3 Guangdong Japan 6866 6846
4 Beijing UK 6826 6866
5 Zhejiang France 6863 6863
6 Shandong Korea 6854 6821
7 Henan Switzerland 6810 6877
8 Hubei Ireland 6856 6854
9 Hebei Sweden 6846 6810
10 Tianjin Finland 6822 6864
50% of the total number of manufacture in China
Catalogue of Medical device classified category can be downloaded from CIRS’s website: http://www.cirs-md.com/news_and_events/Medical_Device_Industry_Statistics.html
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1. Glance on Regulatory Updates
China restructured its regulatory authorities
September
2008
March 2013
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2. Glance on Regulatory Updates (continued)
New Regulations for the Supervision and Administration of Medical Devices （ Decree No.
650 ） had been implemented from June 1st 2014, and with its measures and normative
documents on registration, manufacture, distribute , use of a medical device etc. , implemented
from Oct. 1st 2014.
China restructured its medical device regulatory system
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2. Glance on Regulatory Updates (continued)
2013.3
2014.06.01
2014.10.01
2015.01.01
2015.04.01
Milestones for medical device regulatory updates
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2. Glance on Regulatory Updates (continued)
2000 version 2014 version
any instrument, apparatus, appliance, material, or other article whether used alone or in combination, including the software necessary for its proper application. It does not achieve its principal action in or on the human body by means of pharmacology, immunology or metabolism, but which may be assisted in its function by such means; the use of which is to achieve the following intended objectives:1. Diagnosis, prevention, monitoring, treatment or alleviation of disease; 2. Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap conditions;3. Investigation, replacement or modification for anatomy or a physiological process;4. Control of conception.
Any instrument, apparatus, appliance, material, in vitro diagnostic reagents and calibration substances and other similar substances and related articles, including the needed computer software. Its main effectiveness is achieved via physics ways and so on. It does not achieve its principal action in or on the human body by means of pharmacology, immunology or metabolism, but which may be assisted in its function by such means; the use of which is to achieve the following intended objectives:1. Diagnosis, prevention, monitoring, treatment or alleviation of disease;2. Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap conditions;3. Investigation, replacement or modification for anatomy or a physiological process;4. Life support or maintenance;5. Control of conception；6. Offer information for medical or diagnosis purpose via inspecting the human samples.
Expanded the definitions of “medical device”
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2. Glance on Regulatory Updates (continued)
Medical devices manufacturer and distributor must establish and follow the medical device quality management system, the quality management system are known as Good Manufacturing Practices (GMP) for manufacturer and Good Supplier Practices (GSP) for distributor respectively.
Type For Which MDs are Concerned Implementation Date
GSP All medical devices distributing Dec 12th, 2014
GMP
Sterile and implantable medical devices manufacturing Jan 1st, 2011
New establishment or update of manufacturing license for class medical devicesⅢ
Oct 1st, 2014
Class medical devices manufacturingⅢ Jan 1st, 2016
All medical devices manufacturing Jan 1st, 2018
GMP & GSP implemented on medical device
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Streamline the classification process• Provisions on medical device classification• Classification catalogue of medical device
Class IClass IIClass III
Pre-classification and confirmation prior to registration
Risk based classification.
To consider a device’s intended purpose, structural characteristics, method of
use, and other relevant factors.
The minimum managing level of disposable aseptic surgical devices is
changed from class I to class II.
CFDA revised the classification catalogue of medical device
CFDA created an online platform for medical devices classification
determination.
If a new medical device that does not fit under a category recognized in
classification catalogue, you can follow the registration procedure for class III
medical device directly, or,
Determine the category according to the classification rules, or
Petition the NIFDC for a classification determination
2. Glance on Regulatory Updates (continued)
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Registration technical evaluation and administrative approval accelerates
2. Glance on Regulatory Updates (continued)
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New submission procedure for IVDs registration
- Administrative Measures for the Registration of In Vitro Diagnostic Reagents(CFDA order No. 5)
Former procedure New procedure
Similar to devices submission procedure
2. Glance on Regulatory Updates (continued)
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Simplify the pre-market approval and registration process for lower-risk medical devices
Class I medical devices is no longer required to be registered and only need undergo a filing procedure
Domestic devices manufacturer is no longer required to obtain a manufacturing license prior to applying for
registration for its product.
Expended the medical device registration certificate’s validity period from four years to five years.
Registration renewal changed to re-registration application when certificate expires.
The introduction of <Special Review Procedure of Innovative Medical Devices> offers a green channel for a number
of innovative products, which allows companies to communicate with center of medical device evaluation (CMDE) in
advance, and greatly shorten the period of review and approval procedure but without reduction of evaluation criteria
and approval process
Amendments to name and address of the applicant, name and address of the agent, manufacture address for domestic
medical devices is no longer required to apply for administrative approval and only to record it. Registration need
only be submitted during the device license term if a change occurs that affects the safety and efficacy of the device.
2. Glance on Regulatory Updates (continued)
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Some medical device’s managing category changed
There are some devices deemed to be no longer managed as class I medical devices in China Sterile medical device Sanitary materials contained disinfectant Surgical instruments used with the endoscope Orthopedic surgical instruments directly contacted with intervertebral space when used Collective packing product contained higher control level medical devices
CFDA will assign the classification to each new medical devices after expert reviewed.
Determine the new classification of your devices
Check if it is complied with the new product mandatory standard.
Petition CFDA for classification determination via online application system.
Submit the update registration dossier to CFDA and obtain the new medical device registration
certificate
How to comply when classification changed?
2. Glance on Regulatory Updates (continued)
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New confirmation process for safety and biological evaluation report
The medical device registration inspection should be conducted in Chinese qualified laboratory which
approved by CFDA, however, test report of class I medical devices and biological evaluation can be issued by
overseas laboratory, but the test method should be equal to Chinese national standard. (GB/T 16886, equal to
ISO 10933)
New process
Former
Subject the original version with translated version to qualified testing institute approved by CFDA, The testing institute review it and integrated it into the registration testing report.
The biological evaluation report is the part of product R&D documents, it is complied in the registration dossier and submitted to CFDA directly.
Overseas biological test report reviewed and confirmed process changed
2. Glance on Regulatory Updates (continued)
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3. Significant changes to clinical trial
Guideline to conduct medical device clinical
trail in China
GCP-The Quality Management Practices for
Medical Device Clinical Trial
Technical guiding principle on medical devices
clinical evaluation
The Technical Guidelines for In Vitro Diagnostic
Reagents Clinical Trial
Administrative Measures for Medical Device
Clinical Trials Institution Qualification
Determination
Temporary provisions for medical device clinical
trials approval
The catalogue of medical device exempted from
clinical trial in China
Is it class I medical devices in China?
Is it Medical Devices
Is it listed in the catalog of medical devices exempted from clinical trial
Does it comply with the national or industrial standard？
Submission of clinical evaluation report (exemption)
Yes
No
No
Yes
Yes
No
Conduct the clinical study according to the provisions for clinical trials of medical devices in China (GCP)
Yes
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3. Significant changes to clinical trial (continued)
Main changes to clinical trial
Class I medical devices do not require China-based clinical study, but the clinical assessment report is
required.
The class II or III medical devices listed on the devices catalogue designated by CFDA can be exempted
from clinical trial in China- The catalogue of medical devices exempted from clinical trial
The class II or III medical devices clinical trial will be exempt under three circumstances:
① With explicit working mechanism, complete design, skilled manufacturing technique, or similar products that have been
working on the market for several years and with no serious adverse events and the general-purpose doesn’t change.
② The safety and effectiveness of medical device can be ensured via other data rather than clinical trials.
③ The safety and effectiveness of medical device can be ensured by analyzing and evaluating the data gained from clinical
trials or the data of same type medical devices.
There is not required to apply for approval from CFDA or a provincial regulator before conducting a
clinical trial for all devices except for high-risk Class III devices, which will require approval from the
national CFDA itself before any clinical trial may be initiated
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4. Innovative Medical Devices Registration and Approval
Special Review and Approval Procedure for Innovative Medical Devices (CFDA notice No. 13 2014)
1. The applicant, through his/her technological innovation activities, possess a
core technology invention patents of the product by Chinese law, or possess
invention patents or the right to use by transferring ; or core technology patent
is published by the Patent Administration of the State Council.
2. The main mechanism of the products is initiated in china, and the
performance or safety of the products has been greatly improved compared to
similar ones. The technology of the products is in the international advanced
level, and has significant clinical application value.
3. The applicant has completed preliminary research and has the basic
product sample , all research work real and controlled , research data
integrated and traceable.
Innovative medical devices
Simplify the review and approval procedure for innovative medical devices
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4. Innovative Medical Device Registration and Approval(Continued)
Innovative Medical Devices special approval application form
Medical device testing institute shall give priority to do medical device registration tests after getting the test samples, and give out test reports pre-evaluate feedback forms of medical device which is intended to register
clinical trials for innovative medical device shall conduct according to requirements of medical device clinical trial related regulations.
Innovative medical device evaluation office 40 working days.
Innovative medical device evaluation office Center for Medical Device Evaluation (CMDE) 10 working days.
Submission and approval procedure for innovation medical devices
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5. Amendments to Medical Device Registration
Contents of medical device registration certificate
Registration Certificate
Key contents New version Former version
Validity period 5 years 4 years
Chinese legal representative
Indicated on the certificate N/A
Technical Requirements Provided as appendixIndicated the name of product standard
After sales service agent N/A Indicated on the certificate
Registration No.国械注进 ××××3×4××5××××6
国食药监械（进）字 ××××3 第 ×4××5××××6 号
Update Certificate issuanceIssued the supplementary documents to the original certificate.
Issued an new certificate and withdrew the original certificate.
Renewal Deadline to apply forRenewal applied before 6 months of the date of certificate expires.
Re-registration applied within 6 months of the date of certificate expires.
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Practical Advice for Foreign Devices Entering into China Market
Healthcare Product
Is your product a medical device or in vitro diagnostic (IVD) reagent in China?
Have you already applied for and obtained the appropriate license or
registration certificate ?
Pre-market Approval: Classification, testing, clinical trial, submission and evaluation, labeling, license for
manufacturing and distributing, Customs clearance, etc.
Post-market Surveillance: Quality management system (GMP or GSP), advertisement approval, adverse event monitoring and reporting, Recall, etc.
Yes
No
Subject to other regulations? (e.g. regulations on drug, cosmetic,
disinfectant, etc.)
Apply for license or registration certificate update or renewal
Yes
No
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Regulatory Compliance in China
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Resources
China Food and Drug Administration (CFDA)
http://www.sda.gov.cn/ Center for Medical Device Evaluation of CFDA(CMDE)
http://www.cmde.org.cn/ Catalogue of Qualified Medical Device Testing Institute in China (EN)
http://www.cirs-md.com/uploads/soft/150309/6_0932286511.pdf Catalogue of China Medical Devices Standard (EN)
http://www.cirs-md.com/uploads/soft/150211/6_1647487101.pdf Catalogue of Medical Devices Exempted from Clinical trials in China (EN)
http://www.cirs-md.com/uploads/soft/150407/6_1339418521.pdf Catalog of high risk medical devices
http://www.cirs-md.com/uploads/soft/150209/6_1413172091.pdf
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