Medical injection molded parts manufacturers shall meet the following standards:
(i) Possess production sites, environmental conditions, production equipment, and technical personnel suitable for the production of medical injection molded parts;
(ii) Have an institution or full-time inspection personnel and inspection equipment for quality inspection of the produced medical injection molded parts;
(iii) Have a management system to ensure the quality of medical injection molded parts;
(iv) Have after-sales service capabilities suitable for the produced medical injection molded parts;
(v) Meet the requirements stipulated in the product development and production process documents.
For manufacturers engaged in Class I low-risk production of medical injection molded parts, where routine management can guarantee the quality, the manufacturer shall register with the food and drug administration department of the municipal people's government where it is located and submit supporting documents proving that it meets the conditions stipulated in Article 20 of these Regulations.
For manufacturers engaged in Class II production, which involves moderate risk and requires strict control and management to ensure the quality of its medical injection molded parts. The third category comprises high-risk products requiring strict control and management through special measures to ensure the production of medical injection molded parts. Manufacturers of medical injection molded parts must apply for a production license from the food and drug administration department of the provincial, autonomous region, or municipality government where they are located, and submit supporting documentation demonstrating compliance with Article 20 of these regulations, as well as the registration certificate for the medical devices they produce.
The food and drug administration department accepting the production license application shall review the application materials within 30 working days from the date of acceptance and conduct verification in accordance with the requirements of the production quality management standards formulated by the State Council's food and drug administration department. For those meeting the prescribed conditions, a production license shall be granted; for those not meeting the prescribed conditions, a license shall be denied with a written explanation of the reasons.
HUIWEN Plastics is a group enterprise specializing in precision mold design and manufacturing, and precision injection molded products production for many years. The company focuses on providing comprehensive solutions for reputable brands, integrating product design, precision mold manufacturing, injection molding and assembly, and after-sales service. Its products are widely used in household appliance casings and accessories, medical device injection molded parts, cosmetic packaging injection molded parts, and other fields. Welcome to inquire.
