What is the process for registration and commissioned processing of Class I medical devices?

Should the contract processing agreement be signed before medical device product production registration?

Answer: It should be. Because the registered product standards for medical devices have requirements for production conditions (including site, equipment, personnel, etc.).

Should the entrusted factory first apply for a medical device production enterprise license?

Answer: The production enterprise license is one license for each product. If it is a type of device, no need.

What procedures are required for signing a commissioned processing agreement? Thank you for your attention!

Business licenses, tax registration certificates, legal person power of attorney, etc. from both parties.