A. Legal Accordance
As required by Regulations for the Supervision and Administration of Medical Devices, Provisions for Medical Device Classification,Catalogue of Medical Devices Classification,Provisions for Medical Device Registration,Measures for The Registration and Administration of In Vitro Diagnostic Reagents. An overseas production enterprise exporting class II&Ⅲ medical devices to China shall submit the registration application materials to the NMPA by its representative office established in China or by appointing the legal person of the enterprise within China as its agent.
The medical devices from Hong Kong,Macao and Taiwan shall be registered by reference to the import medical devices.
B. Legal Liability
1.If medical devices are produced without a license, the illegal income, related production materials, tools and equipment shall be confiscated. If the value of the illegally produced product is more than 10,000 yuan, a fine of 10 times or more than 20 times the value of the product shall be imposed, if the circumstances are serious, the medical device license application submitted by the relevant responsible person and the enterprise will not be accepted within 5 years.
2.Where false information is provided or other deceptive methods are used to obtain medical device registration certificate and production license, the licenses shall be revoked and a fine of 50,000 yuan up to 100,000 yuan shall be imposed, and the medical device license applications submitted by the relevant responsible person and the enterprise will not be accepted within 5 years .
3.Forgery, alteration, sale, lease, or loan of medical device licenses, the documents shall be confiscated or revoked, and the illegal gains shall be confiscated, if the illegal gains are more than 10,000 yuan, a fine of 3 times to 5 times the illegal gains shall be imposed,if it constitutes a violation of public security management, the public security organ shall impose administrative penalties for public security in accordance with law.
C. Documents Provided by Client
1.A copy of the business license of the agency in China.
2.Copy of identity document of the legal representative and the person in charge of the enterprise.
3.Plan of production site.
4.List of main raw materials, material, production process and equipment.
5.Test samples for product registration.
6.Enterprise qualification certificates of overseas registrants.
7.Product registration certificate/license.
8.QMS certificate of overseas production enterprise.
9.Certificate of overseas sales.
10.Power of attorney for appointed agent.
11.Clinical trial data.
12.Original text of product manual and label draft.
(Remarks: If the overseas production enterprise need to be reviewed on-site, needs to provide further information)
D. Professional Services from ZOOP
1.Full services of planning, QMS guidance, product registration.
2.Acting for product registration(excluding QMS guidance and on-site service).
3.Services specializing in registration materials supplement.
4.Services specializing in pre-review the quality management system assessment.
5.Building the quality management system and pre-review the quality management system assessment.
6.Acting for product test.
E. Period required for registration and validity period of registration certificate
Estimated period for import class II&Ⅲ registration:1-2 years(excluding clinical trial duration)
The registration certificate shall be valid for 5 years and shall be renewed 6 months prior to expiration.
E. Services Flow Chart