Product Registration and Regulatory Updates

1
Product Registration and Regulatory Updates

• Don Chen, MBA
• CMDA North American Liaison Office

2
Agenda

• Regulatory Environment
• SFDA Medical Device Registration
• SFDA Health Food Registration
• Regulatory Updates
• Implications for Manufacturers

3
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)

4
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

5
AQSIQ

• 7 categories of MD requires CCC mark
• 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

6
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

7
SFDA Registration, Cont.

• Required documentation
• 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

8
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

9
(No Transcript)
10
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

11
SFDA Registration, Cont.
12
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.

13
Health Food Registration

• 27 categories of health functions claims are
  approved by the SFDA
• 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

14
Health Food Registration

• Required Documents
• Health food registration application form.
• A copy of legal registration certificate of
  applicants.
• Products Chinese name approval notification
• Letter of guarantee stating no infringement of
  preparatory rights
• Copy of trade registration certificate
• Product RD 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.

15
Health Food Registration

• Required Documents
• 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
• 2 pieces of unopened samples

16
Health Food Registration Process
17
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

18
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

19
SFDA Updates

• Product Re-evaluation
• 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
• 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

20
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

21
Thanks www.cmda.gov.cn www.cmdae.com www.medical2c
hina.com