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).

7. Documents needed for registration(2) • Medical equipment specification;the 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 enterprise;to 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 enterprise’s 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

11. 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 jpigroup’s 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.