Medical device class II production and sales need several certificates

There are three certificates required for the production and sale of Class II medical devices.

They are medical device manufacturer's license, medical device registration certificate and medical device business license. The medical device manufacturer's license is issued by the drug supervision and management department, proving that the enterprise has the qualification and ability to produce medical devices certificate. The medical device registration certificate is issued by the State Drug Administration to prove that the medical device meets the relevant national standards and regulations and can be marketed. Medical device business license is issued by the drug supervision and management department, proving that the enterprise has the qualification and ability to operate medical devices certificate.

Medical insurance reimbursement methods are as follows:

1, before medical treatment: Before medical treatment, you need to confirm the type and scope of your own medical insurance, and choose the medical institutions and doctors in line with the medical insurance policy, in order to ensure that the medical expenses can be reimbursed;

2, during medical treatment: During medical treatment, you need to accurately fill in the basic personal information and medical treatment, and provide your medical card and relevant information to the doctors and medical institutions. Provide doctors and medical institutions with their health insurance cards and relevant supporting materials;

3. Reimbursement application: After the end of the medical treatment, you need to submit the application for reimbursement of medical expenses to the local social insurance management center or medical insurance office, and provide relevant medical bills and supporting materials, such as outpatient invoices, prescription pads, medical records, etc.

4. Reimbursement review: medical insurance institutions review and verify the medical expenses and reimbursement of medical expenses, and then reimburse the medical expenses. The medical insurance organization reviews the application for reimbursement of medical expenses and checks information such as expenses and medical conditions to determine the reimbursement rate and amount;

5. Reimbursement Payment: After the review is approved, the medical insurance organization pays the reimbursement amount to the applicant's bank account or medical insurance card.

In summary, three certificates are required for the production and sale of medical devices class II, which are medical device manufacturer's license, medical device registration certificate and medical device business license.

Legal basis:

"Chinese People's **** and State Social Insurance Law"

Article 23

Employees shall participate in the basic medical insurance for employees, and shall pay the basic medical insurance premiums by the employer and the employees in accordance with the state regulations **** the same. Individual industrial and commercial households without employees, part-time employees who do not participate in the basic medical insurance for employees at the employing organization, and other flexibly employed persons may participate in the basic medical insurance for employees, and individuals shall pay the basic medical insurance premiums in accordance with the state regulations.