How to Register A Foreign Medical Device

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• How to Register A Foreign Medical Device

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How to Register A Foreign Medical Device
Documents Preparation
Translation
Create a Chinese Registration Standard
Safety Testing in an SFDA Testing Center
Clinical Trial (If Required)

• SFDA Approval

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How to Register a Foreign Medical Device
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.
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How to Register a Foreign Medical Device

• 2. Confirm the Product(s) Name and Type/Model

Your Products Name and Model must be Consistent
with your Country of Origin Approval,
Instructions For Use (including your users
manual) and your Product Labeling
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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.
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How to Register a Foreign Medical Device

• 4. Develop a Registration Testing Standard
• as 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 Chinas Professional Standards (YY)
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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
  (ISO109931997 Biological Evaluation of Medical
  Devices Standard)

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How to Register a Foreign Medical Device

• 5. Quality and Performance Testing

• 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

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How to Register a Foreign Medical Device
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
• (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

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How to Register a Foreign Medical Device
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

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How to Register a Foreign Medical Device

• 7. Registration Documents

• Manufacturer Certificate of Quality (original or
  notarized copy)
• (2)  Manufacturers 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

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How to Register a Foreign Medical Device

• 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)
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How to Register An Import Medical Device
7. Registration Documents (Continued)

• (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

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How to Register a Foreign 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 companys stamp
• This Representative can be the same group that
  provides After Sale Support.

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How to Register An Import 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)

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How to Register a Foreign Medical Device

• 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)

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

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Presented By Lawrence Kronick Jyton Medical
America
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Our Medica Booth No.
Hall 13 F25
Jyton Consulting China Medical Tel [phone]
9650 86 10 8260 9560 Fax[phone]
(Beijing office) E-mail reg_at_jtmedical.com for
registration wyx_at_jtmedical.com
for market research Http//www.jtmedical.com
Http//www.jtmedicalusa.com 
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Any questions, please contact Jyton Consulting
China Medical Tel [phone] 10
8260 9560 (Beijing office) Fax[phone]
E-mail reg_at_jtmedical.com for
registration wyx_at_jtmedical.com
for market research Http//www.jtmedical.com
Http//www.jtmedicalusa.com  Add12A09,B2,Long-Ran
ge World Building, No.18, Suzhou Street,Beijing
100080,P.R.China E-mail