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.For Class II medical devices registration, the applicant shall submit the registration application materials to the drug regulatory authority of the province, autonomous region, or municipality where it is located. For the registration of Class III medical devices, the applicant shall submit the registration application materials to the NMPA.
B. Basic conditions of production enterprises
1. Staff Requirements：
1.1 Person in charge: college degree or above
1.2 Management representative (for Class II) : college or above or junior and above technical title,professional related to medical devices, with more than 3 years of experience in quality management or production, technical management, with management representative training certificate, internal auditor certificate.
Management representative (for Class II) :Bachelor degree or above or intermediate and above technical title,professional related to medical devices, with more than 3 years of experience in quality management or production, technical management, with management representative training certificate, internal auditor certificate.
1.3 Quality directer:college or above technical title, related majors of medical devices, at least 1 year related working experience.
1.4 At least 2 testers.
1.5 The company shall have at least two internal auditors, one of whom shall be non-quality personnel.
1.6 The person in charge of the production, technical and quality of the implanted animal-derived medical devices and allogeneic medical devices shall have the relevant academic knowledge in biology, biochemistry, microbiology, medicine, immunology and other fields, and shall have the relevant practical experience.
Remarks: The related majors of medical devices refer to biomedical engineering, machinery, electronics, medicine, bioengineering, chemistry, pharmacy, nursing, rehabilitation, laboratory science, and management.
2.Site requirements: The specific requirements of the production site are different according to the products.
2.1 For passive sterile and non-implantable products, the size of the production workshop for varies products is different; at least 300 square meters,Grade D cleanliness,there should be a microbiology laboratory，it should be class 10,000 cleanliness with a minimum area of 150 square meters and have at least 2 sets of independent air pressure system, one for the positive control room and other for the microexamination room and the sterile room.
2.2 For implantable sterile medical devices in contact with blood or spare parts in single package delivered from the factory,the size of the production workshop for varies products is different,at least 300 square meters,class 10,000 cleanliness with a minimum area of 150 square meters and have at least 2 sets of independent air pressure system, one for the positive control room and other for the microexamination room and the sterile room.
2.3 For passive non-sterile products,different products have different requirements, depending on the product.
2.4 For active non-implantable products, production, inspection, warehouse minimum of 300 square meters.
All the above products require independent raw material warehouse, semi-finished product warehouse and finished product warehouse.
3. Product requirements: The ability to develop and produce samples, product safety, stable performance, and efficacy has been verified.
4. principles of using raw materials:
4.1 Do not use risky raw materials, such as stem cells.
4.2 Materials that can be absorbed by the body during use and that have pharmacological effects (such as a complementary role in the product) will be divided into class III.
4.3 Plant extracts are not recommended as raw materials for medical device products, if added to the formula, all the ingredients extracted from plants need to be listed and explained.
5.Equipment requirements: depending on the product.
C. 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.
D. Documents 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.Test samples for product registration.
9.Clinical trial data.
(*The above mentioned is for reference only. The details will be determined after discussed by both parties.)
E. 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.
F. Period required for registration and validity period of registration certificate
Eight Months to two years (excluding clinical trial duration).
The registration certificate shall be valid for 5 years and shall be renewed 6 months prior to expiration.
F. Services Flow Chart