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Shuzheng Health Consulting Group

How to Register A Foreign Medical Device

Confirm Registration

the

Classification

and

Required

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.

Shuzheng Group:

Tel: 86-01- 83505145-245/ 83502445 Email: [email protected] Fax: 86-01-83505147 Http: www.healthproduct.cn

Shuzheng Health Consulting Group

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 user's manual) and your Product Labeling

Provide Complete Technical Specification and Clinical Data for all your Products including the configuration differences for each device in the product family. 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 China's Professional Standards (YY)

Shuzheng Group:

Tel: 86-01- 83505145-245/ 83502445 Email: [email protected] Fax: 86-01-83505147 Http: www.healthproduct.cn

Shuzheng Health Consulting Group

(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)

Quality and Performance Testing

(1)

Required for Class II and Class III Devices

(2) All Testing Must Be In SFDA Authorized Testing Centers

How to prepare clinical trial documents:

(1) Required for Class II and Class III products

Shuzheng Group:

Tel: 86-01- 83505145-245/ 83502445 Email: [email protected] Fax: 86-01-83505147 Http: www.healthproduct.cn

Shuzheng Health Consulting Group

(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

(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

Shuzheng Group:

Tel: 86-01- 83505145-245/ 83502445 Email: [email protected] Fax: 86-01-83505147 Http: www.healthproduct.cn

Shuzheng Health Consulting Group

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

(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)

Shuzheng Group:

Tel: 86-01- 83505145-245/ 83502445 Email: [email protected] Fax: 86-01-83505147 Http: www.healthproduct.cn

Shuzheng Health Consulting Group

(7) 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

(8) 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.

(9) Letter Authenticating All the Documents and Materials submitted

Shuzheng Group:

Tel: 86-01- 83505145-245/ 83502445 Email: [email protected] Fax: 86-01-83505147 Http: www.healthproduct.cn

Shuzheng Health Consulting Group

(Signed by Manufacturer)

(10) Any other documents that may be required by the SFDA (Signed by Manufacturer)

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)

SUBMISSION

Submit Application to the SFDA and Wait 105 Working Days for Certificate Issuance

Shuzheng Group:

Tel: 86-01- 83505145-245/ 83502445 Email: [email protected] Fax: 86-01-83505147 Http: www.healthproduct.cn

Shuzheng Health Consulting Group

For More Information, Please Visit: Http: www.healthproduct.cn

Any Question, Please Contact: Shuzheng Consulting: (Registration Agent under SFDA and MOH, involving dietary supplements, cosmetics, medical devices etc.)

Tel: 86-01-83505145-132 /83502445 Fax: 86-01-83505147 Email: [email protected] Add: Suite 7B103, Qingzhiyuan, 47 Yuxin St., Xuanwu District, Beijing, China.

--- The End

Shuzheng Group:

Tel: 86-01- 83505145-245/ 83502445 Email: [email protected] Fax: 86-01-83505147 Http: www.healthproduct.cn

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