SFDA Service

1
SFDA Service

• For Israeli Medical Equipment Exporters

2
Market background

• Israeli medical equipments have been active in
  Chinese market
• GE, Talia, ESC Sharplan, HAM-LET

3
What can we do?

• Agent for medical equipment registration,
  medicine registration, cosmetic registration,
  health food registration, FDA market entry
  consultation, CE certificate consultation, market
  survey, clinic experiment, professional
  translation etc.

4
Services provided

• Domestic brand medical equipment registration    
  
• Product registration for each category of medical
  equipment
• Imported medical equipment registration   
• Imported product registration and registration
  for medical equipment which has not been approved
  by overseas medical equipment authorities
• Registration certificate    
• Re-registration for medical equipment
  registration certificate alteration    
• Re-registration of Medical equipment registration
  certificate    
• Alteration of medical equipment registration
  certificate    
• Re-applying for medical equipment registration
  certificate

5
Medical equipment registration procedure
6
Documents needed for registration(1)

• Overseas medical equipment registration
  application form
• Qualification verification of medical equipment
  production enterprises
• Copy of the operation license of applicant and
  authorization letter issued by production
  enterprises for empowering the agent to register
• The verifying document approved or recognized by
  overseas medical equipment authorities on
  approving the entrance of the product into the
  market of this country (region)
• Adaptive product criteria
• The product which adopts the China national
  standard, industrial standard as the adaptive
  product criteria, will be required to submit the
  context of adopted China national standard and
  industrial standard registered product standard
  should be stamped by production enterprise or its
  representative office in China or the authorized
  organization entrusted by the production
  enterprise. There must be clear statement of
  product quality is the responsibilities of
  production enterprise in the authorization
  letter.
• Production enterprise must provide the compliance
  statement for their products, which is in line
  with China national standard and industrial
  standard. Production enterprise is obliged to
  ensure the quality of marketed product and give
  the specifications on the type of product and
  other classifications.
• The stamp refers to stamp of organization or
  signature of its legal person, director, or
  signature plus stamp (the same definition applies
  to all overseas medical equipment hereinafter).

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Documents needed for registration(2)

• Medical equipment specificationthe second and
  third category of medical equipment specification
  should be stamped by production enterprise or its
  representative office in China, the first
  category of medical equipment specification do
  not need to be stamped
• Product registration testing report issued by
  medical equipment testing institute (for the
  second and third category of medical equipment)
  the medical equipment which requires clinic
  experiment will need the testing report issued by
  medical equipment testing institute in half year
  before the clinic experiment. The medical
  equipment which does not require clinic
  experiment, shall submit testing report issued by
  testing institute in one year before
  registration. When implementing the procedures
  regulated in term 11, 12, 13 and 14, the related
  explanatory document will be needed.
• When implementing the procedures regulated in
  term 15, production enterprise should submit the
  application to suspend the testing. In the
  application, the enterprise must guarantee that
  the registration testing will be fulfilled before
  the first piece of product being put into
  production.
• Materials about medical equipment clinic
  experiment (the way of submission refers to annex
  12)
• Product quality warrant letter by production
  enterpriseto assure the quality of the product
  which is registered, sold in China must be the
  same as the identical product approved by
  overseas medical equipment authorities in foreign
  countries.

8
Documents needed for registration(3)

• Authorization letter to China agent provided by
  production enterprise, commitment letter of
  authorized agent and its operation license or
  registration document the commitment of
  authorized agent must be in accordance with the
  authorization letter. In addition, the authorized
  agent should commit to take the responsibility of
  reporting the bad event caused by using the
  medical equipment, and contact with the (food)
  medicine supervisory and management dept.
• Authorization letter for dominating the
  after-sales services organization in China,
  commitment letter of the authorized Chinese
  organization and qualification document
• After-sales service authorization letter shall be
  issued by production enterprise, it must address
  the product name when multi-tier authorization
  occurs, authorizing organizations at each level
  must provide the approving document from
  production enterprise.
• The commitment letter of after-sales service
  organization should be in line with the
  authorized issue addressed in authorization
  letter.
• The qualification verifying document of
  after-sales service organization is the operation
  license (the scope of operation should incl.
  equivalent technical services) or registration
  document of production enterprises china
  representative office
• Claim on the accuracy of the materials.

9
Our past experiences and track record

• Our company has a strong team familiarizing with
  the application procedures of medical equipment,
  medicine and cosmetics, as well as the relevant
  regulation, law and policies in China. Our
  experienced and reliable experts can provide
  comprehensive support by our proved operational
  system. We provide consulting services on medical
  equipment, medicine and cosmetics on both
  regulatory and technical issues which has been
  proved prompt and high-quality.

10
Our team capability

• Wang Jian
• Yidong King
• Helen Tong Gao
• Joanna Chao Guo

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Dr. Yidong King

• Graduated from the Capital Medical University in
  1979
• Physician in Beijing Red Cross Hospital for 9
  years practicing medicine in the one of the
  biggest hospitals in China made him to achieve a
  thorough understanding of medication and medical
  equipment use.
• During that period he also published 26 thesis on
  internal medicine at home and abroad.
• Dr. King joined the United Nations Development
  Program (UNDP) as a community medicine specialist
  and then worked abroad for UNDP and other member
  organizations of the United Nations for 12 years.
  Dr. Y. King has therefore rich international
  experience.
• After join JPI Group of Companies as its Vice
  President Dr. King has been in-charge of
  consulting projects in medical fields.
• He is responsible for our internal operation but
  also serves as the Assistant Director of the
  Chinese Pharmaceutical Association and the Senior
  Consultant of the Wu Jieping Medical Foundation
  and therefore is well connected with all the
  relevant parties as far as medical equipment and
  medication projects are concerned.

12
Tong Helen Gao

• Graduated from Capital Medical University at 1992
  and practiced as paediatrician.
• Joined Galxo-wellcome as Senior officer of
  external affair at 1993 and moved to Roche at
  1999.
• 10 years experiences dealing for companies
  governmental relations, PR and product
  registration and product pricing.
• Currently served as jpigroups affiliate
  consultant for our services of health care
  product registration and product pricing, market
  entrance and product distribution.

13
Joanna Guo

• Graduated from Capital Medical University at 1992
  and practiced as Pediatrician.
• Joined jpigroup at 1992 and is served as
  Co-President right now.
• Rich experience in project management in project
  development for health care sector and product
  registration with SFDA
• Senior consultant for marketing services
  consultancy for health care and chemical
  products.
• Extensive experiences with international clients
  and understand the needs in matching with local
  circumstances.