The production of medical mould injection components is vital to medical safety and quality. Therefore, manufacturers must strictly adhere to the following standards:

1. Infrastructure and Technical Support:

• Manufacturers must possess production sites, superior environmental conditions, advanced production equipment, and professional technicians that match the production of medical mould injection components.

2. Quality Inspection System:

• Establish a dedicated quality inspection agency or assign full-time inspection personnel, equipped with corresponding inspection equipment, to ensure rigorous control over product quality.

3. Quality Management System:

• Establish a comprehensive quality management system to provide a solid guarantee for the quality of medical mould injection components.

4. After-Sales Service Capability:

• Possess after-sales service capabilities that are compatible with the produced medical mould injection components to meet customers' comprehensive needs.

5. Product Development and Production Process:

• Strictly comply with the requirements outlined in product development and production process documents to ensure that every aspect of the product, from design to production, meets the standards.

For the production of medical mould injection components with low risk levels that can be ensured through routine management, manufacturers need to register with the food and drug administrative department of the municipal people's government in the district where they are located and submit proof of compliance with relevant regulations.

However, for medical mould injection components with moderate risk levels that require strict control and management, as well as those with higher risk levels that necessitate special measures for strict control and management, manufacturers must apply for a production license from the provincial, autonomous regional, or municipal people's government's food and drug administrative department. When applying, apart from submitting proof of compliance with relevant regulations, they must also provide the registration certificate for the medical devices they produce.

The food and drug administrative department, upon receiving the production license application, shall review the application materials within 30 working days and conduct an inspection in accordance with the national production quality management standards. For those that meet the prescribed conditions, a production license will be granted; for those that do not, the application will be rejected, and a written explanation will be provided.

Yize Mould, established in 2007 and headquartered in Dongguan, the manufacturing hub with convenient transportation and logistics, is a seasoned manufacturer specializing in precision mould design and manufacturing, as well as precision injection molding products. The company focuses on providing integrated solutions for the design of automotive connectors, medical product injection molding, cleanroom injection molding, PFA custom injection molding, precision mould manufacturing, injection molding and assembly, and after-sales service.