Medical Device GXP(GMP,GCP,etc.) System Implemented in China - Regulatory News - Medical Devices

In order to strengthen the medical devices supervision and guarantee the safety of medical devices, CFDA has issued a series of Good Practice such as Good Manufacturing Practice, which contain to the all life cycle of medical device of approval, manufacturing, supply and use.
Excepted for GMP, do you know other GXP System? The list of GXP as following:

1. GXP list

GXP	English Name	Chinese Name
GLP	Good Laboratory Practice (unimplemented)	醫療器械非臨床研究質量管理規范 (未實施)
GCP	Good Clinical Practice	醫療器械臨床試驗質量管理規范
CMP	Good Manufacturing Practice	醫療器械生產質量管理規范
GSP	Good Supply Practice	醫療器械經營質量管理規范
GUP	Good Use Practice	醫療器械使用質量管理規范

2. The Action Stage of GXP

3. Implementation time of GXP

GXP	Implementation time
GCP:
Good clinical practice for medical device	Exposure Draft
Technical guideline for clinical evaluation of medical device	2014.09.11
Technical guideline for clinical evaluation of In Vitro Diagnostic Reagent	2015.05.19
GMP:
Good Manufacturing Practice for medical device	2015.03.01
Good Manufacturing Practice for Medical Devices Appendix for Sterile Medical Devices	2015.10.01
Good Manufacturing Practice for Medical Devices Appendix for Implantable Medical Devices	2015.10.01
Good Manufacturing Practice for Medical Devices Appendix for In Vitro Diagnosis Reagents	2015.10.01
Guideline for Medical Device Good Manufacturing Practice On-site Inspection	2015.09.25
Guideline for Medical Device Good Manufacturing Practice On-site Inspection for Sterile Medical Devices	2015.09.25
Guideline for Medical Device Good Manufacturing Practice On-site Inspection for Implantable Medical Devices	2015.09.25
Guideline for Medical Device Good Manufacturing Practice On-site Inspection for In Vitro Diagnosis Reagents	2015.09.25
REMARKS: 1.All Class III medical device manufacturers shall conform to these rules before 2016.01.01; 2. All medical device and in vitro diagnostic reagent manufacturer shall conform to those rules before 2018.01
GSP:
Good Supply Practice for Medical Device	2014.12.12
Guideline for Medical Device Good Supply Practice On-site Inspection	2015.10.15
GUP:
Administrative Measures for Quality Supervision on the Use of Medical Devices	2016.02.01

4. Supervising pattern of GXP

GXP	Object of supervision	Supervising pattern	Supervising subject
GCP	Clinical trial institutions	1. On-site Inspection 2. Supervision & Inspection 3. Self-Inspection	Food and Drug Administration
GMP	Manufacturers
GSP	Manufacturers and Distributors
GUP	Medical institutions: Hospital, Beauty salon, etc.

5. How to execute the GXP?

How

GCP:

The medical device with Practicing License of Medical Institution or qualification of Grade 2A and above can apply for GCP License according to Determination Measurement of Qualification of Medical Device Clinical Trial Institutions (Exposure Draft)

GMP:

Pursuant to the specified clauses of Guideline for Medical Device Good Manufacturing Practice On-site Inspection:
1.The result of inspection is disqualification if the clauses with “*”¹ are not conformed to;
2.The result of inspection is disqualification if the clause without “*”²which can affect the quality of product are not conformed to.
3.The result of inspection is rectification and re-inspection if the clause without “*”²which cannot affect the quality of product are not conformed to.

GSP:

In according with the specified clauses of Guideline for Medical Device Good Supply Practice On-site Inspection:
1.The result of inspection is disqualification if the clauses with “※”¹ are not conformed to;
2.The result of inspection is disqualification if discord rate of the clause without “※”²are larger than 10%;
3.The result of inspection is rectifications within a time limit if discord rate of the clause without “※”²are less than 10%;

GUP:

In according with the requirements of Medical Device Good Use Practice including purchasing, storage, use and maintaining, etc.

REMARKS:
1.The clause with “*”or “※” refers to key item;
2.The clause without “*” or “※” refers to general item;The number of clauses without “※” not conformed to/( Total number of clauses without “※”—Total number of clause without “※” which is inapplicable )*100%

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