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Procedure Name

Special Permit for importing medical instruments, equipment, accessories and prostheses

Description

Category	SPECIAL PERMIT
Responsible Agency	Name: MINISTRY OF HEALTH Address: Mongolia, Ulaanbaatar 14210 Sukhbaatar District 14210 Olympic Street - 2 Government Building VIII, E-mail: info@moh.gov.mn Web: https://www.mohs.mn/ Phone: (976) 51-263695 Fax: 11-320916
The legal base of the Procedure	Law on Health, 2011 Article No 40.1 The Law on Medicine And Medical Equipment Law on Licensing of Business Activities Order No. 404 of the Minister of Health of 2006 Order No. 145 of the Minister of Health of 2013 Order No. 298 of the Minister of Health of 2014 Resolution No. 311 of the Government of Mongolia of 2011
Fee	N/A

Required Documents

No.	Type of information	Note
1	Application for a license	Documents necessary for the application
2	Copy of state registration certificate
3	Copy of company charter
4	Introduction of the organization
5	Founder's decision
6	Information about the founder will be provided in accordance with Table №1 of HF Order No. 145 of 2013
7	Charter of medical institution
8	The information of the health worker shall be provided in accordance with Table №2 specified in HF Order No. 145, and in the case of foreign medical professionals, in accordance with Table №3;
9	Internal labor regulations
10	Copies of licenses for medical professionals
11	Employees' civil service application form / must be completed on Form 1
12	A written and concluded employment contract with the employee
13	Certified Employee job descriptions
14	A copy of the contract with the Department of Special Medical Waste, Disinfection and Equipment Maintenance
15	External and internal diagrams; location, structure, and operation
16	The capacity of medical equipment shall be calculated in accordance with Table №4 of HF Order 145
17	The purchase agreement with the manufacturer of medical instruments, prostheses and equipment, and the manufacturer's authorized distributor
18	Manufacturers of medical instruments, equipment, accessories and prostheses for import, supply and sale under the contract have a certificate that meets the requirements of international standards (ISO)
19	Other documents specified in the law depending on the specifics of the production and service	If Applicable

Process Steps

Step1	Prepare a “Project Proposal” to establish a medical equipment supplier The draft shall be written in accordance with Order No. 298 of the Minister of Health of 2014 and Order No. 145 of the Minister of Health of 2013.
Step2	Submit the Application with required Documents In accordance with Order No. 145 of the Minister of Health of 2013 “Requirements for documents to be obtained for obtaining a business license in the field of health”, the documents shall be prepared and submitted to the Secretariat of the Licensing Commission.
Step3	Documents submitted by the applicant shall be evaluated in accordance with the criteria approved by the Annex to the Order No. 203 of the Minister of Health in 2014.
Step4	Issue the Import Special Permit

NOTE:

The technical and quality certification documents for the manufacture, sale, import, supply and use of medical instruments, equipment, accessories and prostheses shall be attached.

Category

Import

The following form/s are used in this procedure

Title	Description	Created Date	Updated Date	Issued By
Special permit application form for obtaining a business license in the field of health, 2013 Order No 145 annex1	This Form applies to the procedure related to obtain Special permit for business activities in the field of health Requirements	30-07-2020	18-08-2020	Ministry of Health
Special permit granting valuation rate form for importing medical instruments, equipment, accessories and prostheses Order No 145	This Form applies to the procedure related to procedure for importing medical instruments, equipment, accessories and prostheses Order No 145	14-10-2020	14-10-2020	Ministry of Health

This procedure applies to the following measures

Name	Measure Type	Agency	Description	Comments	Legal Document	Validity To	Measure Class
Special Permit requirement for importing medical instruments, equipment, accessories and prostheses	Permit Requirement	Ministry of Health	A traders wishing to import and supply of medical instruments, equipment, accessories and prostheses shall be carried out by a legal entity licensed by the state central administrative body in charge of health matters. Technical and quality certification documents for the import, supply and use of medical instruments, equipment, accessories and prostheses shall be attached.	The Special Permit granting process for the import and supply of medical instruments, equipment, accessories and prostheses is a two-step process. The project submitted by the license applicant was discussed at the meeting of the Licensing Commission for Health Professional Activities and “Determining whether the project meets the requirements” was discussed. There are two stages: “Special Permit Application”.	Law on Health, 2011	09-09-9999	Good