China Medical Device GMP Consulting

 

1 Quality management standard for medical device production [on trial]
2 The inspection rule for QMS of medical device production [on trial]
3 The implement rule and assessment standard for QMS of sterile medical device [on trial]
4 The implement rule and assessment standard for QMS of implantable medical device [on trial]
5 Audit rule for QMS of In Vitro Diagnostic Reagent

 

Forms for GMP
1 Inspection application form for QMS of medical device production
2 Review report for application document of medical device production
3 Inspection record on site for QMS of medical device production
4 Summary of inspection record on site for QMS of medical device production
5 Opinion of Inspection on site for QMS of medical device production
6 Result notice of Inspection on site for QMS of medical device production
7 Supervision and inspection opinion for QMS of medical device production