1

الشركات تقييم منتجاتلية آ-----------------

'( §i/_&6_%o<6+jWò&->3aYcI_%>-/Pi�§i/i_&/_%

A. The item will be deemed as "tried and tested"if it satisfies one of the following cases:

1. >C9)§Cag<C6%h`Ä9g<i>h/hf/iE>/\-E§h]i§'§C]ibC_hm[-&E0&IZ&caQ->'0&CN6Äak'fCi_O

�p&KOÅ%̀ h<_%§amicW

1. In case the items were awarded and supplied inone of the last four tenders without any adverse technical remarks or observations being reported by the GCC Member Countries.

2. 0&CC3/ca_%biCCi[/mCCi_)\CCWhfCCaii[/bCC/§hCC]i§'�m_h-[abii[/_%4q&/c0c&]hl<a/Pa_%

2. The case the item has been pre-evaluated inaccordance to the Product Evaluation Mechanism" with acceptable result.

l( \Whmi-M_%<%ha_%0&3/cabii[/b/i�j_i&a@

B. Evaluation of Medical Supplies' Materialsshall be carried out according to the following:

1. <CP-0&]>CG_%§a0&3/ca_%bii[/0&-_M`h-Z'<-i8>CM<CcOjCe/c/hmCIZ&ca`C]miCE>/§ap&e/c�%

�ma<&[_%mIZ&ca_%

1. The period for receiving products’ evaluationrequests commence after completion of the award procedures for each tender. This period ends upon launching the next tender, and according to the announced dates on the official website of the Health Ministers’ Council for G.C.C Countries.

2. jCW.CS>/jC/_%Y&cCIÅ%<Ci<6/-m]>CG`C]bh[/Qa\iEc/_&-&eaii[/FC_3a`h<C_m6CI_%F_3a

§h&P/_%�

2. Every company should coordinate with the GulfHealth Council for Cooperation Council States for specifying the items it desires to evaluate.

3. �&e_id(/<P-�+m]>G_%0&3/cabii[/b/i�3. The company products shall not be evaluated unless the company qualification process is completed.

4. l<C6nC_O`]&eOh>Wh0&]>G_%0&3/cabii[/b/i�j_&/_%.E6

4. Evaluation of the company products and itsaffiliated branches, independently, according to the following:

>i>&C[/QCZ%h§Cam]>CG`C]_l<a/Pa_%Y&cIÅ%�'�&iD_%�l>

a. The accredited company products accordingto the factory visit report.

YC_aQCZ%h§Cam]>CG`C]_l<Ca/Pa_%Y&cIÅ%�.��l>&iD_%§al&c1/Ea_%0&]>G__̀ id(/_%

b. The accredited company products accordingto the list submitted along with the qualification dossier, in case the company is exempted from factory visit.

5. .3iW�l<i<3Y&cI'bii[/jWm]>G_%m-S><cOb/ij]_�l<<6a_%<O%ha_%.E6&e-_M-b<[//§'

�0&]>G_%̀ id(/mc3_n_O._M_%L>O

5. The case the company desires to evaluate newitems; it should submit a request, during the specified period, which shall be present to the SGH Qualification Committee to take the appropriate decision.

2

6. &Ce/&3/camCaq&Z§Ca<hc-`[c0&]>G_%._M<cOl>&CiD_%>Ci>[/jWl<a/Pa_%h`i_<_&-m3><a>iT_%

3/camaq&Z§aK&d<&a/O%hmC3><a_%m]>G_%0&<P-mIZ&ca_%̀ i_<n_+&e/W&K+b/j/_%h�`i_<_%jW0%p%>CC3Ö%=&CC9/%m]>CG_%nCC_PW�QcCCIa_%l>&CiD

�mi_&/_%

6. In case there are new added items to the SGHmanual after the company factory visit, the company should undertake the following procedures in case of desire to shift these new added items, which were unlisted at visit time, to the list of its accredited factory products:

'( 8>M :i>&/ §a >eG `Ä9 ._M m]>G_%b<[/ jch>/]_Ö% QZha_% jW 2å<6a_% `i_<_%F_3a_

§h&P/_%F_3a`h<_m6I_%hc-_% b&Z>(-j/_% <>i>[/ jW l<a/Pa_%h `i_<_% jW ò&1i<6 03><'m3><a>iT_%QcIa_%0&3/camaq&ZjWl>&iD_%

�&d<&a/O%jW.S>/j/_%h̀ i_<_%jW

a. The company should present a request foradding the new items with their code numbers within one month from the date of launching the updated manual on the Gulf Health Council official website. The requested items should be among the accredited items in the factory visit report.

.( bh[i§h&P/_% F_3a `h<_ m6I_% F_3a\i>X_%§'§a\[6/__p&KOÅ%`h<_%m-M&9a-

M9 n_O Q_M% <Z >q%D_%<hc-_% g=d 5&/c+ Mhl>&iD_%>i>[/jWl<a/Pa_%<hc-_%§aK§a&ec'hjW m3><a >iT_% m]>G_% 0&3/ca maq&Z jW

�`i_<_%

b. The Gulf Health Council shall communicatewith the GCC Member Countries to ensure that the SGH auditors had inspected the production lines of the items in question, and to make sure that these items are among the accredited unlisted factory products at the time of factory visit.

5( �p&KOÅ%`h<_%`-Z§a<hc-_% g=d<&a/O% <P- bh[i§h&P/_% F_3a `h<_ m6I_% F_3a

a_% 0&3/ca maq&Z 4a&c>-§aK &e3%><,-QcIJ&9_% `id(/_% Y_a §aKh �k<h]_% bZ>_&-

�^_=-&eSÄ-+h�m]>G_&-

c. Based on the approval of the GCC MemberCountries, the Gulf Health Council shall include these items in the company qualification dossier and them to the company products in the designated program with the relevant code number. The company shall be informed with this addition.

<( o<_bii[/_%._Mbi<[/-m]>G_%bh[/F_3a§h&P/_% F_3a `h<_ m6I_%<hc-_% g=e_

�mW&Ka_%

d. The company shall present a request to the Gulf Health Council for evaluating these new added items.

g( bh[i§h&P/_% F_3a `h<_ m6I_% F_3a�Q-/a_%b&Nc_%hmi_É%.E6<hc-_%g=dbii[/-

e. The Gulf Health Council shall conduct productevaluation for these items in accordance to the applied regulations and Product Evaluation Mechanism.

h( m]>G_%0a<[/`&6jW._M->iS<hc-mW&K+äp%hEl>&iD_% >i>[/h'`id(/_%Y_ajWl<a/Pa

f. In case the company requests adding newitems which are neither in the list submitted along with the qualification dossier nor in any list submitted along with the factory visit

3

�m3><a_% >iT_% h' m3><a_% <hc-_%� maq&Z jWjW 0&]>G_% `id(/ mc3_ n_O &eK>O b/iW

�b<&[_%&eO&a/3%

report, the company request shall be presented to the SGH Qualification Committee in the next meeting to take the appropriate decision.

7. _/0&E&[aQia3_bii[/_%._Mbi<[/-m]>G_%bD/<hCCc-_%mCCaq&Z§aCCKh`i_<C_%jCCWmCC3><a_%<Cc-_%

jWm]>G__l<a/Pa_%F_3a`h<_m6I_%F_3a§h&P/_%b<COh&Ce-m]>&CGa_%m]>CG_%khCc/j/_%h

�§iE&[ah'F&[a-p&X/]�%

7. The company shall be committed to present arequest for evaluating the different item's sizes included in the SGH manual which are the among the list of the accredited factory products at the Gulf Health Council which it intends to participate with in the SGH tenders, and should not restrict evaluation of only one or two sizes.

8. U_-i§h&CP/_%F_3a`h<_m6I_%F_3am]>CG_%bh[/CCEjCC/_%hp&CCKOÅ%`h<CC_%§CCa2ÄCC1p&aCE(-`h<CC__0&CC-M&9a_%§CCal>hCCI`CCE>/hbii[/_&CC-

�p&KOÅ%

8. The Gulf Health Council Board Office shall informthe company with the three GCC Member Countries who shall conduct product evaluation. Copy of the exchanged correspondences shall be sent to the concerned GCC Member Countries.

9. QCa\iCEc/_&-mCiW&]0&CciObi<[/-m]>G_%bD/_/\C_P/i&CaiW&Ca'�m_h<`]jWmI/9a_%0&e3_%mi-M_%0%>-/9a_%bD%h_jWmII9/a_%0&]>G_&-

nC_PW�b<C_%`[c0&a<9h0&CciObi<C[/m]>CG_%nCCc<%<CC6-hfCCaii[/<%>CCa_%4/CCca_%§CCamCCiW&]

`CCi_&6a__100§CCO`CC[i� §%nCC_O�JCC6W§i/i_iTCCCCG/(2 batches)<%hCCCCa__m-CCCCEc_&-h

m]_e/Ea_%30�l<6h

9. The company should provide sufficient quantityof samples of the item that needs evaluation. Manufacturers of Medical Laboratories supplies should provide sufficient quantity of samples with minimum quantity (100 tests) for the reagents of, at least, two batches. Quantity of samples to be provided for other consumable items are 30 (thirty) pieces.

10. C_%bh[/l<&CW,-`h<FC_3a`h<C_m6CI_%FC_3a§h&CCP/_%b%<9/CCEÄ_l<CCa/Pa>CCiT_%<hCCc-_%§CCO

0&]>CG_%§Ca&Cei_+m_CE>a_%hmi6I_%&e/(Gca-�bii[/__

10. The GCC Member States should notify the GulfHealth Council with the items that are not used in their hospitals, in case samples for such items are delivered to them for the purpose of evaluation.

11. <ihD/-p&KOÅ%̀ h<_%bh[/F_3am6I_%̀ h<_§h&P/_%F_3a-4a&c>-\i>M§Obii[/_%4q&/c

�jch>/]_Ö%M->_%

11. The Member Countries shall provide the GulfHealth Council with the evaluation results according to the designated program via electronic connectivity.

12. mai[a§h]/§%.3i�bii[/n_+5&/6/j/_%<hc-_%l>%Dh&Ceci-§Cap&CKOÅ%`h<C_%§Ca`h<2Ä1jWjCWmC_h-[abiCi[/_%mC3i/ch�mi<hPCE_%m6I_%m-h_Mamia]n_O'.6&Im_h<_%&aeiW&a-§i/_h<

12. Items that need pre-evaluation must beevaluated in three GCC Member countries; the Saudi Ministry of Health shall be one of them. Evaluation result shall be considered from two countries, including the country that has biggest required quantity.

4

12�'–O`&6jWmC_h<_%§CabiCi[/_%mC3i/c<h>hb<�biCi[/_%jCW&d>9(/.-E->-]�%mI6_%0%=§Cal<>%hC_%biCi[/_%m3i/c>&-/O�%jW=9~iW

� §ii>9É%§i/_h<_%

12/a. In the event of delay in receiving evaluation result from the GCC Member Country with the largest quantity due to delay in performing evaluation, then the evaluation result received from the other two GCC

12�.–m_h<_% §a bii[/_% m3i/c <h>h b<O `&6jWbi<[/jWm]>G_%>9(/.-E->-]�%mI6_%0%=�>-]�% mI6_%0%=m_h<_%o<_ bii[/__0&ciP_%

<c-_% %=d miE>/ <&P-/E% b/iWFO&[/_ ò%>Nc�m_h<_%g=do<_&e/&3/cabii[/jWm]>G_%

12/b. In the event of delay in receiving evaluation result from the GCC Member Country with the largest quantity due to negligence of the company, then the offered bid by the company for such item shall be eliminated.

12�5�bii[/-jX/]iW0&E&[al<Of_<c-bii[/<cO%<O&a<6%hF&[aPediatric, or adult

12/c. The item that has different sizes, it shall be sufficient to evaluate one size except (pediatric or adult).

13. �miO&cI_%mi_]_%bD%h_mIZ&ca_%n_O0&]>CG8>CM§CaY&C]0CZh`C-Z&e/&ciObi<[/-bh[/§%

�p&KO�%`h<_%jW&eaii[/b/in/6mIZ&ca_%

13. Manufacturers of renal dialysis supplies shouldprovide samples for evaluation, at the GCC Member Countries, well before the due date for launching the tender.

14. &ca�mCCi-M_%kh&CCE]_%h0&CCEh-_a_%mCCIZnCC_Obi<CC[/<CCcO&CCe/&ciObi<CC[/-bhCC[/§%0&]>CCG_%

�&eKh>O

14. Manufacturers of linens and medical uniformsshould provide samples for evaluation at the time of offering their bids.

15. �bii[/_%m3i/c-m]>G`]VÄ-+b/i15. Every company shall be informed about the evaluation result of its factory products.

16. jCWbiCi[/_%mC3i/c`hC6m]>G_%0&N6Äa`-[/�m3i/c_&-&eSÄ-+:i>&/§a>eG&d&IZ'l<a

16. The company observations about the evaluationresults of its factory products shall be accepted within a period not exceeding one month from date of providing such result.

17. b<C[//<Cc-`C]_5h_&C/]_%bCZ>>]=-m]>G_%bD/_/`&C9<%<CcOp&CKO�%`h<C_%nC_Oh�faii[/._M-l>h>Kjch>/]_�%M->_%4a&c>-jWbii[/_%m3i/c

�<c-`]_5h_&/]_%bZ>>]=h`h<C_m6CI_%F_3a_%FCC_3a§h&CCP/_mCC3i/c<&CCa/O%b<CCOjCCW\CC6_%

�5h_&/]bZ>f_>]=ib_<c-k�bii[/_%

17. The company is committed to mention thecatalogue number for each item it presents for evaluation. The GCC Member Countries should mention the catalogue number for each item while entering evaluation result in the designated program via electronic link. The Gulf Health Council shall have the right not to consider evaluation result of any item without catalogue number.

18. p&CCKOÅ%`h<CC_%§CCamCCicW0&CCN6Äa<h>h<CCcOYcIk'n_O�`ZÅ%n_O§i/_h<��`hC-[ahbiC[a

l<&CCO+.CC3ih�m[-&CCE_%biCCi[/_%4q&CC/cnCCT_/W�<i<3§afaii[/

18. In case adverse technical observations on anyitem are reported by the GCC Member Countries, minimum two of the member countries, then all previous evaluations of such item(s) shall be void and must be re-evaluated.

19. \-CEj/_%0&]>G_%0&3/cabii[/l<&O+b/i0%hcCEQC->'.>C3/h'b<9/CE/b_h&eaii[/

19. Items that are not used or tried and tested forfour consecutive years should be re-evaluated. But, items relating to the following tenders: (Orthopedic & Spine, Rehabilitation supplies,