Transcript Product Registration and Regulatory Issues

Product Registration
and Regulatory
Updates
Don Chen, MBA
CMDA North American Liaison Office
Agenda
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Regulatory Environment
SFDA Medical Device Registration
SFDA Health Food Registration
Regulatory Updates
Implications for Manufacturers
Regulatory Environment
 State Food & Drug Administration (SFDA)
• Became part of MOH since Mar 2008
• National regulatory authority of drug and medical
device
• In charge of comprehensive supervision on food
safety management
 General Administration of Quality Supervision,
Inspection and Quarantine (AQSIQ)
• Drafts rules and regulations on certification and
accreditation, safety and quality licensing, hygiene
registration and qualification assessment
• Conducts mandatory safety registration, certification
and inspection for certain devices (CCC mark)
SFDA
 All imported medical products must be
registered with SFDA prior to selling in
China
 Products made outside China need to go
to central SFDA for approval
 Registration is valid for 4 years
 Registration cannot be transferred
AQSIQ
 7 categories of MD requires CCC mark
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Medical diagnostic X-Ray Equipment
Haemodialysis Equipment
Hollow Fiber Dialysers
Extra-Corporeal blood circuit for blood purification
equipment
• Electrocardiographs
• Implantable cardio pacemakers
• Artificial heart lung machine
 Enforces safety and quality standards of
medicines and health products
SFDA Registration
Required documentation
• SFDA registration form
• Legal production qualification (FDA registration)
• Business license of Chinese agent, who must be located
in China, have a valid business license and a letter of
commission from the manufacture
• Marketing approval from government of country of origin
• Product Standard
• Operation Manual
SFDA Registration, Cont.
Required documentation
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Test report issued by SFDA-certified test center
Clinical trail report
Quality Guarantee letter
Letter of authorization to agent undertaking the
registration
• Post-sales authorization
• Self-guarantee declaration
SFDA Registration, Cont.
 Medical device classification
• Class I: low risk, considered safety, general control
safety and effectiveness can be ensured through routine
administration
• Class II: middle risk, relative safety, special control
further control is required to ensure their safety and
effectiveness
• Class III: high risk, highly special control implanted
into the human body, or used for life support or
sustenance, or pose potential risk to the human body
and thus must be strictly controlled in respect to safety
and effectiveness
SFDA Medical Devices Classification
Active Device
Passive Device
Form of Operation / Type
of device
Device for transportation
and storage of
pharmaceutical liquid
Device for alternation of
blood and body fluid
Device for medical dressing
Surgical instrument
(inserted)
Reusable surgical
instrument
Disposable aseptic surgical
device
Implantables
Device for contraception
and birth control
Device for sterilization and
cleaning
Other contacting passive
device
Device for Treatment
through energy
Device for diagnostic
monitoring
Device for body fluid
transportation
Device for ionized radiation
Other general active device
Contracting or inserted Device
Temporary Use
Short-term use
Long term use
Skin,Cavity Trauma Blood Circulation Skin,Cavity Trauma Blood Circulation Skin,Cavity Trauma Blood Circulation
and Tract Tissue Central Circulation and Tract Tissue Central Circulation and Tract Tissue Central Circulation
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SFDA Registration, Cont.
 Registration timeline
• Class I: 5-6 months
• Class II & III without clinical: 7-8 months
– Marketed in country of origin
– Manufacture is ISO 9000-certified
– Product modification does not affect safety and
efficiency
– Non-implants, no radioactive sources
– Would not cause serious injury or death to
patient and operator
• Class II & III with clinical: 12-14 months
SFDA Registration, Cont.
Class 1 products
Dossier Preparation
& Spec Drafting
2-3 Months
Sampl
e
testing
Filling
90 working
days
Evaluatio
n Center
Review
No
1 month
Yes
Clinical Trial
Clinical trial not required
Final Approval
Health Food Registration
 Health food is defined as food that has specified
health functions, suitable to be taken by specified
group(s) of people, and for the regulation of the
functional states of the human body and is not used
for the treatment of diseases.
 The category includes vitamin and mineral
supplements that may not be used for the purpose
of disease treatment.
 All health food sold within China must be approved
and registered with the SFDA, which will assess
and examine the security, effectiveness, quality
control and labeling of products.
Health Food Registration
 27 categories of health functions claims
are approved by the SFDA
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Enhancing immune function, Improving sleep, Improving endurance
during anoxia, Assisting protection against irradiation, Increasing
bone density
Improving tired eyesight, Eliminating acne, Eliminating yellow-brown
spot, Improving skin moisture, Improving skin oil content, Improving
constipation, Assisting protection against chemical liver injury
Assisting blood lipids reduction , Assisting blood sugar reduction,
Antioxidation, Assisting memory improvement, Facilitating lead
excretion, Moistening and cleaning throat, Assisting blood pressure
reduction, Increasing milk secretion, Improving growth and
development, Improving nutritional anemia, Regulating intestinal
micro flora, Facilitating digestion,
Alleviating Physical Fatigue, Controlling obesity
Health Food Registration
 Required Documents
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Health food registration application form.
A copy of legal registration certificate of applicants.
Product’s Chinese name approval notification
Letter of guarantee stating no infringement of preparatory rights
Copy of trade registration certificate
Product R&D Report
Product formula and formula basis, and the origin and usage basis
of raw and supplementary materials
Effective ingredients/ representative ingredients, contents, and
testing methods for effective ingredients / representative
ingredients
Diagram of productive techniques, detailed explanation (including
original and translated version) and related research materials
Product quality standards (corporation standards, including original
and translated version) and its compiling explanation, and quality
standards of raw and supplementary materials.
Health Food Registration
 Required Documents
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The category, name, quality standards, and selective basis of
packing materials that in contact with products.
Test report issued by accredited organizations
Sample product label and usage instructions
Legal production qualification issued by country of origin
Notarized letter of authorization to Chinese agent and copy of its
business license or Registration of Rep. Office of Foreign Company
Marketing approval showing products has been sold in country of
origin for more than 1 year
Relevant standards of producing country (area) or international
Samples of package, label, directions used in original country, and
its Chinese version
Other information helpful for evaluation
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2 pieces of unopened samples
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Health Food Registration Process
SFDA Updates
 More transparent and streamlined registration
process
• Registration requirements and procedures available
at www.sfda.gov.cn
• Online inquiry of application status
• Reduced redundancies between SFDA and AQSIQ:
– 10 SDFA national testing centers are accredited by
AQSIQ
– SFDA and AQSIQ agreed to use the same report
format
• Re-registration gets easier
 Improved efficiency of medical device testing
• Testing centers perform testing on multiple device
types
• More than 20 provincial level testing centers opened
• Implemented a comprehensive training program
SFDA Updates
 MD Adverse Event (AE) Monitoring and
Re-evaluation
• National ADR center received 12,374 AE
reports in 2007
• Imposes mandatory AE monitoring obligations
– Manufactures, distributors and medical institutions
must set up AE monitoring systems: record-keeping,
tracking (class II & III)
– Standard and annual (class II & III) AE report filing
– Reporting AE discovered outside China
• Control measures by manufactures and SFDA
actions
• Use of AE Reports
– Enhance regulation and Administration, may not be
used to initiate a lawsuit or medical dispute
SFDA Updates
 Product Re-evaluation
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Establish re-evaluation indicators, methods and procedures
Initiate when associated safety risks discovered
SDFA will start re-evaluation if caused serious injury or
death
Revision of specifications or revocation of certification
 New regulations on medical device quality system
management
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“Criterion for Medical Device Quality System Management”
outlines general requirements for medical device quality
system management, covering issues such as design,
production, installation, and sales.
Integrates the ISO 13485 standard and the U.S. FDA
quality system inspection technique along with certain
requirements specific to China
Implication for manufacturers
 Working with a in-country regulatory
representative: Independent or distributor
• Experienced in regulatory compliance
• Well-established and maintained relationship with the
SFDA to ensure Effective and efficient
communication
 Appointment of legal agent
• Required for a foreign medical device manufacturer
that does not have an office in China
• The agent needs to act as a liaison between the drug
administration authorities and the foreign
manufacturer, and is responsible for reporting
adverse incidents and recalling medical devices with
potential safety problem
Thanks
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