During the supervision for pharmaceuticals, medical devices and cosmetics by Shanghai Municipal Medical Products Administration, the interview mechanism and relative regulation have been formed in order to strengthen the security supervision, determine the responsibility of enterprises, prevent illegal behaviors and security cases and practically protect public health. The specific regulation details of which are listed below by Donjin.
This interview mechanism is a meeting raised by Medical Products Administration with legal representatives, persons in charge or other responsible staffs from license holders of pharmaceuticals, registrants and recording persons of cosmetics, production and trading units of pharmaceuticals, medical devices and cosmetics, when there is a behavior violated laws and regulations or there is a hidden danger. The interview aims to prevent and control the risk, clear the hidden danger, give a hint or warning to supervise and urge the rectification. It shall be managed territorially, legally and efficiently.
The interview may be raised under these circumstances:
- When security cases of pharmaceuticals, medical devices and cosmetics occurs;
- when it might be proved that there is hidden danger and it hasn't been removed in time;
- when there might be a huge hidden danger that product is unqualified or with abnormal result under selective examination or risk motoring;
- when it was reported by people, exposed by media or when there are many cases under investigation or with big influence;
- when there is false registration document or there is reality doubt for clinical trial sample;
- when there is serious default in quality managing system and the rectification remains useless;
- when the recall for product is insufficient;
- when the credit evaluation is untrustworthy or highly untrustworthy;
- other circumstances which may be interviewed by laws and regulations.
Before the interview, the Medical Products Administration shall make a notification with name of the interviewer, issue, time, location and main participants delivered to the business unit of the interviewer.
During the interview, at least two supervisors from the Medical Products Administration shall take part in to form an interview, and arrange a special assistant to take notes for the interview. The host and others who take part in the interview shall sign on the interview note.
The content of the interview shall include notification of the question and hidden danger occurred, propaganda of relative laws and regulations, requirement for rectification, management circumstance and the statement of the interviewer.
After the interview, the Medical Products Administration shall make a administrative suggesting letter based on the fact or other relevant law enforcement documents ordering rectification within a time limit.
This regulation would be effective on the date of December 1st, 2020 and would be expire in 5 years.
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