【EXPERT Q&A】What qualifications are required to sell a Class of medical devices?
April 11, 2024
Source: drugdu
100
Drugdu.com expert's response:
To sell Class I medical devices, you typically need to obtain the following qualifications:
Medical Device Operation License: According to the "Regulations on the Supervision and Administration of Medical Devices," any unit or individual engaged in activities such as production, operation, use, or technical services of medical devices must obtain a medical device operation license to operate medical devices.
Business License: As a business entity, you need to have a valid business license to engage in legal business activities.
Other Relevant Qualifications: Depending on the specific situation and requirements, you may also need to obtain other relevant qualifications such as medical device registration certificate, production license, etc.
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