Q：
|
What is the Medical Instrument Production License?
|
A：
|
The Medical Instrument Production License is the legal certificate that enterprises engaged in the production of Class II and Class III medical instruments should obtain according to law.
|
Q：
|
Is there duplicate in the Medical Instrument Production License?
|
A：
|
The Medical Instrument Production License is divided into original and duplicate. The original and duplicate have the same legal effect.
|
Q：
|
How long is the validity period of Medical Instrument Production License?
|
A：
|
5 years.
|
Q：
|
Which enterprises need to apply for Medical Instrument Production License?
|
|
A：
|
Enterprises engaged in the production of Class II and Class III medical instruments shall obtain the Medical Instrument Production License according to law with the approval of the drug regulatory department of the province, autonomous region or municipality directly under the central government where it is located.
|
Q：
|
How long does it take to apply for the Medical Instrument Production License?
|
|
A：
|
The drug regulatory department shall review the application documents, check according to the requirements of the medical instrument production quality management standard formulated by the National Medical Products Administration, and decide within 20 working days from the date of accepting the application. If the specified conditions are met, a written decision to grant the license shall be made according to law, and the Medical Instrument Production License will be issued within 10 working days.
|
FAQ
