Sultanate of Oman

Ministry of Health

Directorate General of Medical Supplies

Directives:

This application form should be filled by the manufacturer electronically in MOH website

All required documents should either be in English or Arabic.

Arrangement of original hard copy should follow the same sequence in this form and to be submitted to Department of Specifications & Supplies in the Directorate General of Medical Supplies.

PART - I :

1- Type of Application:

- New

- Re-qualification

2-Payment of pre-qualification fee:

- Cash receipt No: ……………

- Receipt date: ………………

Note: Original payment receipt to be submitted by the Local Agent in Oman along with the original pre-qualification documents.

3- Details of the local Agent in Oman:

Agent Name:
Post Box:
Code No:
Tel. No:
Fax No:
Email Address:
Authorised person

4 – Authorization letter from manufacturer for local agent confirming:

- Full Authorization for all products

- Authorisation for specific products

(List of products to be attached)

PART - II :

1- Factory Details

- Factory Name
- Date of Establishment

2- Address of Factory in the country of origin

Street No.
City:
P.O. Box:
Postal Code:
Country:
Tel No.
Fax No.
E-mail address:

3. The Manufacturer is specialized in:

- Medical laboratory & blood bank Products

- Hospital sundries supplies

- Renal Dialysis supplies

- Oral Dental Health Care products

- Orthopaedic products

- Medical Rehabilitation Supplies

- Cardiovascular Surgery Supplies

- Surgical Instruments

- Other Medical products

4- Number of Factory Branches:

5- Locations of Factory Branches:

Sr. No / City Name / Country Name
1.
2.
3.
4.
5.

6- Statement of Manufacture's capital assets and date of establishment and its type.
7. Number of Employees

Departments / Executive / Engineers / Specialists / Technicians / Others / Total
Total Number of Employees =

8 – Required Documents

The certificates shall be attested by the concerned Authorities in the Country of Origin and Embassy of Sultanate of Oman or its representatives

A. A Certificate issued from Manufacturer nominating a Local Agent or deputed body to submit the prequalification requirements to MOH. / YES / NO
B. A Certificate issued by Concerned Authorities in the country of origin indicating that the company is a Manufacturer or Assembler licensed to manufacture medical supplies in the country of origin, and subjected to periodical technical inspection and its products are sold in country of origin. / /
C. Quality Assurance Certificate from the concerned authority ensuring that the manufacturer fulfils the Good Manufacturing Practice (GMP) requirements in accordance with FDA/CE/ISO, etc. / /
D. A Quality Certificate issued by Concerned Authorities for its manufactured products i.e. equipment, Medical diagnostic reagents and other Medical Products such as ISO 9001: 2000/ ISO 13485: EN 46001, FDA. / /
E. A Certificate issued by Concerned Authorities in the country of origin for products made from Plasma or blood derivatives confirming that they are free from any causative agents like HIV, Hepatitis and all other types of infective viruses. / /
F. Site Master Plan File. / /
G. For surgical implants like orthopaedic or cardiovascular, supportive Certificates, scientific researches and clinical studies carried out in the Country of Origin and developed countries should be submitted to ensure the quality, efficacy and safety of their use. / /
H. List of all products manufactured by the Company with their generic names, trade names, catalogue numbers with set of catalogue. / /
I. Statement of the branches and their activists with Legal, Technical and Financial responsibility of the parent company towards its affiliated branch. / /

J. List of countries where manufacturer products are marketed along with documentary evidence proving marketing of these in at least 3 of these countries:(Invoices) -

Sr. No / Country
1.
2.
3.
4.
5.

We ……………………

Certify that we have never been convicted due to forgery or commercial fraud in the country of origin or in any other country.

Auth. Name:.………………………..…………….

Job Title: ……………………………………………

Signature/Stamp: …………………………………….

Date: …………………………………………………

For official use only (by MOH, Oman)

Request No
Date
Staff Name
Concerned department
Signature

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