A.   Legal basis

according to Regulations on the supervision and administration of medical devices  Administrative measures for registration of medical devices ,The firstIFiling of medical device products,The applicant shall submit the filing materials to the local Municipal Drug Administration Department divided into districts.Export to ChinaIOverseas manufacturers of medical devices,Its representative office established in China or an enterprise legal person designated in China shall be the agent,Submit filing materials to the National Bureau.One port Australia Filing of medical devices in Taiwan,Refer to imported medical devices.

B.  Medical device product filing subject

Self produced,The production enterprise shall apply for product Filing Certificate and production Filing Certificate

Commissioned production,The client shall apply for product Filing Certificate and production Filing Certificate,The entrusted enterprise has the corresponding production record certificate

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

C.  Information provided by customers for filing service

1. Copy of business license

2. Legal representative Photocopy of the identity certificate of the person in charge of the enterprise

3. production Identity of person in charge of quality and technology education Copy of professional title certificate

4. Production management Education background of employees in quality inspection position List of professional titles

5. Certificate of production site,Facilities with special production environment requirements shall also be submitted Environmental supporting documents

6. Production site plan workshop Test Room Warehouse

7. Main raw materials Bill of materials Production process Equipment list

8. Qualification certificate of overseas enterprise

9. Overseas filing of products/Registration certificate If overseas does not belong to the supervision of medical devices,The system certificate of the manufacturer shall be provided

10. Certificate of overseas sales of products

11. Power of attorney of appointed agent

12. Original text of product manual and Label Sample

notes among3-6term,Imported products do not need to be provided 8-12term,Domestic products do not need to be provided.

D.  ZOOPProfessional services provided

1. field Personnel planning A complete set of services from system construction to product filing

2. Product filing data compilation and agency filing services

3. Product filing agent testing service

4. Pre audit service of special training for filing supervision

E. Filing cycle

1. domesticIClass estimated cycle 1-3Months,On the premise that the conditions of factories in individual regions meet the requirements1Completed within months

2. ImportIClass estimated cycle 3Months

F.  domestic/ImportIFiling service process of class I medical devices