5. The Company:

6. Commercial Registration:

7. Number of Employees:

Location of the Factory Branches:

Page 1

3. Address of the production site:

No.

4. Company is:

Foundation Date:

Registered Capital: Paid Capital:

Issued by:

Technicians:Executives:

Specialists:

Engineers: Others:

8. Number of the Factory Branches:

Select Tender:

1. Name of the Production Site:

2. Country of Origin:

Street Address:

City: Code:

Phone: Fax:

Email: Website:

P.O. Box.

No. City / Country No. City / Country

1 5

2 6

3 7

4 8

Health Council For

Cooperation Council States

(Mention Country of origin of the production site)

Company / Factory Qualification Form

Company / Factory Qualification Form

9. The Company Ownership:

10. Companies with Joint Ownership:

11. List of Countries wherein the company products are marketed (attach evidence e.g.AWB or B/L etc.):

(b) Foreigner %(a) Gulf % (c) Joint Venter %

City: Code:

Phone: Fax:

Email: Website:

10/a Name of the Partner :

10/b Name of the Foreign Partner:

P.O. Box.

No. No.

1 6

2 7

3 8

4 9

5 10

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12. The Company local Agents/Distributors in the GCC Member States:

12/a Saudi Arabia:

City: Code:

Phone: Fax:

Email: Website:

P.O. Box.

City: Code:

Phone: Fax:

Email: Website:

P.O. Box.

Health Council For

Cooperation Council States

Company / Factory Qualification Form

The Required Qualification Documents (must be in English Language):

1. Application Form 2. Quality Certificates: (must be attested by the consulate of any of the GCC States in

the country of origin). 3. Free Sale Certificate: (must be attested by the consulate of any of the GCC States in

the country of origin). This certificate is to be issued by an accredited authority, stating that the company products which shall export to GCC countries are of the same quality circulating in the country of origin.

4. List of countries wherein the company products are marketed (provide supporting documents to prove such commercial activities e.g. AWB, B/L, P.O. etc.

5. List of the company products use the designated program in the web site) then provide them in both soft copy i.e. in a compact disk and duly signed and stamped original hard copy, together with an updated catalogue of the factory products.

6. List of the company local agents in the GCC States (names, address & Contact numbers).

7. Factory Site Master File (minimum requirement is a layout of the factory). 8. Qualification & registration fees are nonrefundable. They are to be deposited at

SAMBA Bank (IBAN: SA 6940000000000001900846) upon submission of the company pre-qualification file according to the following:

a. Fees for new Company US$ 1,500 b. Fees for Renewal: US$ 1,000

Very Important Notes:1. Manufacturers of diagnostic devices, reagents and medical laboratory materials should

submit the following quality certificates: a. Duly attested (GMP), (ISO 9001-2000), (EN 46001), (ISO 13485). b. Duly attested Quality Assurance Certificate: FDA or CE Mark.

2. Candidates who wish to be qualified for SGH Cardiovascular Supplies' Tenders, should ensure that the following measures are fully satisfied:

a. Manufacturers of the items that would be implanted into human bodies and those containing biological materials must be: (manufacturers and research companies) rather than (generic companies).

b. Manufacturers of of the items that would be implanted into human bodies and those containing biological materials should submit clinical studies issued at the country of origin by accredited international research centers certifying the result of using these items at the country of origin for, at least one year, and should provide accreditation certificates (FDA and CE) too.

Page 3

Health Council For

Cooperation Council States

Company / Factory Qualification Form

3. Applicants who wish to be qualified for SGH Medical Staff Uniforms, should submit the following documents in addition to the above mentioned documents (No need to provided Free Sale Certificate):

a. Valid manufacturing license for producing medical staff uniforms and textile materials.

b. List showing number of the labourers & employees and their specialties. c. List showing all types and numbers of factory machines and equipment, including

stitching, cutting and preparation machines. 4. The Health Council reserves the right not to receive incomplete files. 5. The application form is to be filled-up a in typing. It must be stamped with the company

official stamp and signed by the authorized person whose name and job title should be clearly indicated.

6. All required documents are to be submitted in two forms: a. Hard Copy: The hard copy should be kept in a dossier with numerical separators, all

dossier contents are to be arranged according to their sequence as listed above. b. Soft Copy: All qualification documents should be made in one PDF file burned in a

compact disk (CD). The contents of the CD should be identical to the hard copy's. We………………………………………………

Certify that we have never been convicted due to forgery or commercial fraud, and we also confirm that the products for export are same as those used in the country of origin.

Page 4

Company / Factory Name:

Nationality :

Name of the authorized Person /

Job title /

Signature / Stamp

Date/Time Field

The company pre-qualification file should be delivered to the Health Council, by hand, via the company local agent in Saudi Arabia against payment of the above mentioned fees by a certified cheque in the Name of: Health Council For Cooperation Council States

Health Council For

Cooperation Council States

Company / Factory Qualification Form