Inventory of Business Licenses

General information
Name of formality	Permit for Import Medical Equipment
Type of formality	Other
Date of last modification	19.11.2020
Responsible Authorities	Food and Drugs Department
LSIC
Who should complete this business formality?	A company obtaining a licensing pharmacist from the Food and Drug Department.
Qualifications needed by the business to get the formality
Additional Comment	Second-hand medical equipment (used equipment) is not considered importable.

LEGAL FRAMEWORK
Name	Number	Date	Comment
Law on Drugs and Medical Products (Amended)	07/NA	21.12.2011
Notice on the Required Documents for the Application on Import Raw Materials, Packaging, Medicine and Medical Equipments for Manufacturing and Distribution	2660/16.FDD	16.06.2016
No name	NO	23.06.2023

REQUIRED DOCUMENTS FORMALITIES - First time
Name	Type	Comment
Request Letter	Confirmative act	to import medical equipments
Invoice	Confirmative act	3 copies
Packing List	Confirmative act	3 copies
Purchase Order (PO)	Confirmative act	3 copies
ISO 13485 Certificate	Confirmative act	of every imported equipment
Certificate of Analysis	Confirmative act	of every imported manufacture (for condoms)

REQUIRED DOCUMENTS FORMALITIES - Renew
Name	Type	Comment

 

Mean of presentation
Means of presentation
Address of authority	Food and Drugs Department, Ministry of Public Health
Processing Time (Day(s))	3

 

RENEWAL INFORMATION
Does the formality have a validity or an expiration date?	NO
How long will the formality be valid for? (in months)	0
What is the process and conditions to get the formality?
What is the process and conditions to renew the formality?

 

ISSUING FEES
Has application fees?	Service fees	Certificate fees	Application fees	Total fees
YES	0.00	20000.00	0.00	20000.00
Comments	Refer to the Ordinance No. 003/PO

 

RENEWAL FEES
Has renewal fees?	Service fees	Certificate fees	Renewal fees	Total renewal fees
NO	0.00	0.00	0.00	0.00
Comments

   

REQUIRED DOCUMENTS
Document Name	Comment
Request Letter	to import medical equipments
Invoice	3 copies
Packing List	3 copies
Purchase Order (PO)	3 copies
ISO 13485 Certificate	of every imported equipment
Certificate of Analysis	of every imported manufacture (for condoms)

 

STATISTICS (Issue or/and renewed number)
Year	Issued	Renewed
2019	539	0
2020	374	0