how to register a foreign medical device. sfda approval documents preparation translation create a...
TRANSCRIPT
How to Register A
Foreign Medical Device
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 IClass I Medical Devices: safety and effectiveness can be ensured through routine administration;
Class IIClass II Medical Devices: further control is required to ensure their safety and effectiveness;
Class IIIClass 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 inc
luding the configuration differences for each d
evice 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 (GB9706.1-1995 or equal to IEC60601.1: 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
Presented By:
Lawrence Kronick
Jyton Medical America
Our Medica Booth No.
Hall 13 F25Jyton Consulting & China Medical
Tel: +86 10 8260 9650 +86 10 8260 9560
Fax ： +86 10 8260 9925 (Beijing office)
E-mail: [email protected] for registration [email protected] for market researchHttp://www.jtmedical.com Http://www.jtmedicalusa.com
Any questions, please contact:
Jyton Consulting & China MedicalTel: +86 10 8260 9650 +86 10 8260 9560 (Beijing office) Fax ： 8610-92609925 E-mail: [email protected] for registration [email protected] for market research
Http://www.jtmedical.com Http://www.jtmedicalusa.com Add:12A09,B2,Long-Range World Building, No.18, Suzhou Street,Beijing 100080,P.R.China E-mail: