What qualifications do you need to produce medical devices?

Medical device production license, medical device registration certificate, product standard certification certificate, patent certificate.

1. Medical device production license: The medical device production license is the primary certificate of medical device production, which is used to prove that the enterprise has the qualifications and conditions to produce medical devices.

2. Medical device registration certificate: The medical device registration certificate is used to prove that the safety and effectiveness of medical devices meet the relevant national standards.

3. Product standard certification: Medical device products must meet national and industry standards before they can obtain product standard certification.

4. Patent certificate: The design and technology of medical device products must comply with the provisions of the Patent Law before a patent certificate can be obtained.