51吃瓜

??? ??? ???? ?????, ?????????? ?????? ??????????? ????? ??????? ??? ?????? ????????????? ????? ?????????? ???????, ??? ?? ????? ??? ??????? ????дар?? ????? ?????????. ?????? ????? ???????????? ???????????, ????? ??? ???????? ?? ?????????

1, Approval authority: Enterprises engaged in the operation of Class II and III medical devices shall report to the Provincial Drug Administration for review and approval, and be issued a "Medical Device Operation Enterprise License".

1. ???????????????? ????????? ??????????????? (?????????? ??? ??? ????????????????? ??????????????? ????? ?????????? ??? ??????) ????? ???????? ???????? ???? ??? ???? 2. ??????? ??????????????? ??? ????????? ???? ????? ????????? ??? ????????? ???????????? ???? ?? ??????????????????? Departments ??? ???? ?????. ???? ??? ????????? ??? ???????????, ??? ???? ?????? ?? ?????? ???????? ???????? ???????? ??? ?? ?????????? ???????????? ??????? ????? ??????? ???

2, Deklaration materials:

1. ???? ???????????? ??????????????;

2. Fill out three copies of the application form for the Medical Device Business License (photocopies are invalid);

3. ???? ??????? ??? ?? ????? ? ??????????? ??? ?? ????? ????????? ?????????? ????????? (????? ?????????????? ????????????, fornese ??? ????????? ? ????????????? ??? ?????? ?????

4. ???? ??????? ??? ??? ?????????????? ????? ????????????? ?????? (??? ???????? ??? ?? ??????? ??? ?? "???????????????? ?????? ????? ????????????? ??????????? ??? ????????? ???????????? ???????????? ???????????????? ??? ???????????? ????????

5. ? ????? ??? ???????? ??? ???????? ???????, ??????? ??? ???? ?????? ??? ????? ?????? ????????????? ??? ???? ?????? ??? ????? ?????????????? ???? ????????????? (???????? ??? ??? ???????? ??? ??? ??? ??????);

6. ???? ??????? ??? ??????????? ?????????? ??????????? ????? ??????говоренность ??? ?????????? ????? ?? ??????????? ??? ????????? ????????;

7. ???? ?????? ??????? ??????????????? ??? ????????????Rapport ??? ??? ??????????? ??????? ?????????????? (???????? ????????????? ?????????????);

8. One copy of the business name pre registration certificate or the copy of the "Corporate Business License";

9. ?????????? ?????????????? ??? ????????. a. Quality responsibility and veto power system; b. ??????????????????, ?????????, ??? ????????? ??????????????? ??????; c. Quality analysis and feedback system; d. ??????????????????????? ??????; e. ????????? kwalite? ????????? ?????? ????? ?????????? f. ???????? ?????? ????? ????????? ??? ????????????? ?????????? ??????; ??????; h. Quality tracking and adverse reaction reporting system for implanted and special medical devices; i. ??? ?????, ??? ???????????????, expiration date ????? ?????????? ???? ?????????? ?????? ?????????? ???????? ??????; ???. ???? ????????? ????????? ??????;

10. ? ????????????? ????????? ????????? ???? ???????? ???? ??? ?????? ??????????????.

3, ??????? ????????

1. ?? ????????????? ???????????????? ????????? ??? ????? ???????? ???????????? ??? ?? ???????????? ??????????? ?????? ????? ??? ?????????? ?? ???? ??? ???????? ???? ???????? соответствующий ??????????? ????? ???????? ??? ?????????????? ????????????????? ??????????? ?? ???????? ?????????? ????-???? ??? 15 ????????? ???? ??? ??? ???? ??? ??????????, ??? accordance with the Implementation Rules for Qualification Recognition of ?? ???????????????????? ????: ?????, ??????, 倉庫庫, ??????? ??? ???????????????????, ????????????? ??? ????????????????????, ??????????? ?????? ????????????, ??????? ????????? ???? ??????? ?????????, ???????? ??? ???? ???? ?? ????? ??? ?????????? ??????? ?????????? ??? ?? ???

2. ???? ???? ???????? ??? ?????????? ???? ??? ??site, ????? ????????? ??? ??????????? ????????????? ???????? ??? 10 ????????? ???, ?????????? ??????????????? ????? ???????? ??? ?????????????

4, ???????????? ????? ??кларации ???????????

1. ??? ??????????????????????????? ???? ????: ??? ?????????? ???????? ???? ??? ???????????????, ??????????? ???? ??? ????? ????? ??? ???????????, Departments ???????, ?????? ???????, ?????? ?????? ????? ??? ?????? ????????? ??

2. ????? ??? ???????? ??? ???????? ???????: ?? ?????? ??? ?? ???????? ??????? ??? ????????? ??? ?????????, ???????, ?????????? ??? ?????????.

3. ?????? ??? ????????? ??? ????????? ?????????: ?? ????????? ??? ????????? ????????? ????? ????? ????? ????, ???? (?????), ????????, ????????????, ???? ??? ??????? ??????????, ??? ????

4. ???? ???????????? ??????????? ???? ??? ????? ???? A4 ???????? ??? ????????????? ??? ??? ????????? ??? ??? ??? ??????????, ???? ????????, ????? Supervisory Unit. ??? ???????????? ?????? ??? ????? ?????? ??? ?? ??????? ??? ??? ?????? ?????????????? ????? ??? ?????????? ????? ? ?????????????????????, ??? ?? ???????? ??? ??? ???????? ?? ??????? ??? ?????? ??? ??? ???: ?? ??????? ????? ????????? ??? ??? ???????? ??? ??? ????????? ??? ? ??? ??? ???.

5, ?????? ????

Enterprises and units should follow the above approval procedures and requirements for declaration. It is strictly prohibited to give gifts of property to the handling personnel. If anyone requests or accepts property, please report to the Supervision Office of the Provincial Drug Administration.