How to Register A Foreign Medical Device

SFDA Approval Documents Preparation Translation Create a Chinese Registration Standard Safety Testing in an SFDA Testing Center Clinical Trial (If Required)

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

2. Confirm the Product(s) Name and Type/Model How to Register a Foreign Medical Device Your Products Name and Model must be Consistent with your Country of Origin Approval, Instructions For Use (including your user’s manual) and your Product Labeling

How to Register a Foreign Medical Device 3 ． Provide Complete Technical Specification and Clinical Data for all your the Products including the configuration differences for each device in the product family.

4. Develop a Registration Testing Standard as per International and Chinese Standards How to Register a Foreign Medical Device (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)

How to Register a Foreign Medical Device (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)

5. Quality and Performance Testing How to Register a Foreign Medical Device (1)Required for Class II and Class III Devices (2) All Testing Must Be In SFDA Authorized Testing Centers (3) Testing Centers Have Specific Areas of Expertise and Are Device Specific

(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 (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 How to Register a Foreign Medical Device 6. 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 How to Register a Foreign Medical Device 6. How to prepare clinical trial documents:

7. Registration Documents How to Register a Foreign Medical Device (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

7. Registration Documents (Continued) How to Register a Foreign Medical Device (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)

(8) Authorization Letter for After Sale Support to Local Distributor (Signed by Manufacturer)  Distributor must be licensed and local  Distributor must be registered with the SFDA to provide after sales service for medical devices How to Register An Import Medical Device 7. Registration Documents (Continued)

(9) Authorization Letter for Legal Representative to a Local Distributor or Agent (Signed by Manufacturer)  Representative must be licensed and local  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. How to Register a Foreign Medical Device 7. Registration Documents (Continued)

(10) Letter Authenticating All the Documents and Materials submitted (Signed by Manufacturer) (11) Any other documents that may be required by the SFDA (Signed by Manufacturer) How to Register An Import Medical Device 7. Registration Documents (Continued)

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) How to Register a Foreign Medical Device

SUBMISSION Submit Application to the SFDA and Wait 105 Working Days for Certificate Issuance How to Register a Foreign Medical Device

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