Registering a Foreign Medical Device in China Prepared by: Diversity Medical Services A Division of Shanghai Jian Tong Medical Equipment Company Ltd.

Registering A Foreign Medical Device in China SFDA Approval Documents Preparation Translation Create a Chinese Registration Standard Safety Testing in an SFDA Testing Center Clinical Trials (If Required)

Registering A Foreign Medical Device in China 1. 1.Confirm the Classification and Required Registration Certificates (China Compulsory Certification ((CCC)) for Your Product) Class I Medical Devices: safety and effectiveness can be ensured through routine administration; Class II Medical Devices: further control is required to ensure their safety and effectiveness; Class III Medical Devices: 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.

Registering A Foreign Medical Device in China 2. Confirm the Product(s) Name and Type/Model Your Products Name and Model must beconsistent with the Country of Origin,Approval, Instructions For Use (including your user ’ s manual) and your Product Labeling

Registering A Foreign Medical Device in China 3. Provide Complete Technical Specification and Clinical Data for all your the Products including the configuration differences for each device in the product family.

Registering A Foreign Medical Device in China 4. Develop a Registration Testing Standard per International and Chinese Standards (1) Must Include Technical and Safety Requirements (2) All Requirements Must Be Equal to or Exceed Chinese National Standards (GB) or China ’ s Professional Standards (YY)

Registering A Foreign Medical Device in China (3) What Are The Safety Requirements? – – Safety Requirements For Electronic Medical Devices (GB or equal to IEC : 1988, Medical Electrical Equipment, Part 1: General Requirements for Safety) – – Safety Requirements For Material Medical Devices (ISO10993:1997 Biological Evaluation of Medical Devices Standard)

Registering A Foreign Medical Device in China 5. Quality and Performance Testing (1) Required for Class II and Class III Devices (2) All Testing Must Be Done In SFDA Authorized Testing Centers (3) Testing Centers Have Specific Areas of Expertise and Are Device Specific

Registering A Foreign Medical Device in China 6. Prepare Clinical Trial Documents: (1) Required for Class II and Class III products (2) Medical Devices That Were Required To Do A Clinical Trial in Their Country of Origin Must Provide a Copy of the Relevant Clinical Reports (2) Medical Devices That Were Required To Do A Clinical Trial in Their Country of Origin Must Provide a Copy of the Relevant Clinical Reports (3) Medical Devices That Were Not Required To Do A Clinical Trial in Their Country of Origin Must Provide Copies of Relevant Medical Reports and/or Literature (3) Medical Devices That Were Not Required To Do A Clinical Trial in Their Country of Origin Must Provide Copies of Relevant Medical Reports and/or Literature

Registering A Foreign Medical Device in China 6. How to Prepare Clinical Trial Documents: (4) Local Clinical Trials are required under the following conditions: Class III Implantable Device (more than 30 days): Only for the initial product registration for a given Manufacturer in China Class II or Class III products that do not have Country of Origin approval (5) All the local clinical trials must be performed in SFDA Approved Clinical Research Institutions (Hospitals) (6) A Minimum of Two clinical sites are Required

Registering A Foreign Medical Device in China 7. Registration Documents (1) Manufacturer Certificate of Quality (original or notarized copy) (2) Manufacturer ’ s Business License (3) Certificate indicating the medical device can be sold in that country of origin (original or notarized copy)  EU Companies - CE Mark  US Companies – 510K/PMA and CFG All other Countries ’ products must have Country of Origin approval, CE Mark or FDA approval

Registering A Foreign Medical Device in China 7. Registration Documents (Continued) (4) Chinese Registration Standard (Certified Copy) (5) Instruction Manual/Instructions For Use (Signed by Manufacturer) (6) Clinical Trial Reports (Class II and III ) (Signed by Manufacturer)

Registering A Foreign Medical Device in China 7. Registration Documents (Continued) (7) Authorization Letter for After Sale Support to Local Distributor (Signed by Manufacturer)  Distributor must be licensed and local  Distributor must be licensed and local  Distributor must be registered with the SFDA to provide after sales service for medical devices  Distributor must be registered with the SFDA to provide after sales service for medical devices

Registering A Foreign Medical Device in China 7. Registration Documents (Continued) (8) Authorization Letter for Legal Representative to a Local Distributor or Agent (Signed by Manufacturer)  Representative must be licensed and local  Representative must be licensed and local  An acceptance letter from the local Representative or Agent should be included with that company ’ s stamp  An acceptance letter from the local Representative or Agent should be included with that company ’ s stamp This Representative can be the same group that provides After Sale Support.

Registering A Foreign Medical Device in China 7. Registration Documents (Continued) (9) Letter Authenticating All the Documents and Materials submitted (Signed by Manufacturer) (10) Any other documents that may be required by the SFDA (10) Any other documents that may be required by the SFDA (Signed by Manufacturer) (Signed by Manufacturer)

Registering A Foreign Medical Device in China – – All Documents Must Be Translated into Chinese and by Certified by the Manufacturer to be Originals – – Translation of the Instruction Manual and or Instructions for Use should follow the Provisions on Instruction for Use and Labeling of Medical Devices (SFDA order No.10)

Registering A Foreign Medical Device in China Theoretically, it takes 64 working days to pass all testing performed by the Medical Device Quality Supervision and Testing Center. But the precondition is that manufacturer submit all the documents before hand. It will take another 64 working days to wait for license issuance from the SFDA should there be no need for clinical testing. SUBMISSION Theoretically, it takes 64 working days to pass all testing performed by the Medical Device Quality Supervision and Testing Center. But the precondition is that manufacturer submit all the documents before hand. It will take another 64 working days to wait for license issuance from the SFDA should there be no need for clinical testing.

Registering A Foreign Medical Device in China

Agent Contact: Diversity Medical Services Co., Ltd Diversity Medical Services Co., Ltd –Suite 11F, Zhong Xi Mansion – Jiangsu Road –Shanghai, PRC Tel: (021) Tel: (021) Fax: (021) Fax: (021) Web: Web:

Client List Health Research International (HRI; USA) Health Research International (HRI; USA) Baylis Medical (Canada) Baylis Medical (Canada) IDC (Canada) IDC (Canada) China Aerospace Science and Industry Corp (CASIC) Institute 207 China Aerospace Science and Industry Corp (CASIC) Institute 207 Saipu Jiu Zhou (Beijing) Saipu Jiu Zhou (Beijing) Shanghai Fu Xing Medical Equipment Company Ltd. Shanghai Fu Xing Medical Equipment Company Ltd. Shanghai Yi Xin Medical Equipment Company Ltd. Shanghai Yi Xin Medical Equipment Company Ltd.