A.   Legal Accordance

As required by Regulations for the Supervision and Administration of Medical Devices and Measures for the Supervision and Management of Medical Device Operation,for the filing of Class I medical device products, the applicant shall submit the filing materials to the local drug regulatory department of the city divided into districts.For overseas production enterprises that export Class I medical devices to China, their representative offices established in China or designated corporate legal persons in China shall be their agents and submit the application materials to the National NMPA.The filing of medical devices from Hong Kong, Macao and Taiwan shall be handled by referring to imported medical devices.The filing of medical devices from Hong Kong, Macao and Taiwan shall be handled by referring to imported medical devices.

B.  About the Filing Applicant

For independent production, the production enterprise shall apply for the product filing credential and production filing credential.

For entrusted production, the entrusting party shall apply for the product filing credential and production filing credential, and the entrusted enterprise shall have the corresponding production filing credential.

For imported products, the domestic agent authorized by the overseas production enterprise shall apply for the product filing credential.

C.  Informatio to be Provided by Client

1. Copy of business license. 

2. Copy of identity document of the legal representative and the person in charge of the enterprise. 

3. Copies of identity document, educational background and professional title  of the person in charge of production, quality and technology. 

4. List of educational backgrounds and titles of employees in production   management and quality inspection positions. 

5. Proof of the production site,if requires special production environment,the certification documents of facilities and environment shall be submitted. 

6. Plan of production site (workshop, inspection room, warehouse). 

7. List of main raw materials, material, production process and equipment. 

8. Documents of qualification of overseas enterprises. 

9. Overseas filing/registration credential of the product(if it is not under the supervision of medical devices abroad, the manufacturer system certificate shall be provided). 

10. Overseas sales ceritificate of the product. 

11. Letter of Authorization of the designated agent. 

12. Original product manual and label. 

Notes:Among them, 3-6 items do not need to be provided for imported products; 8-12 items do not need to be provided for domestic products. 

D.  Professional Services Provided by ZOOP

1.Full services of site and personnel planning, QMS guidance, product filing.

2. Compile application documents and acting for filing.

3. Acting for product testing.

4.Customized training on regulations and pre-review services for factory site and documents. 

E.Required Period

1. Estimated period for Class I domestic MD:1-3 months,which can be completed within 1 month for some factories in some regions on the premise that meet the requirements.

2. Estimated period for Class I imported MD:3 months.

F.  Service Process