Global Import Regulations for

Moldova

General Market Condition: Restricted

Source: Report from CS Post (via E-Mail), 5 April 2001

According to the Ministry of Health and Customs Department, there are no restrictions for import [but see conditions listed below] and sale of used/refurbished medical equipment. Imports of used equipment are treated the same as new. Duties are charged based on the cost of the product. Documentary evidence of cost is preferred.

Generally speaking, three types of taxes are paid on all imports of medical equipment:

• 
  Tax on customs procedures which typically constitutes 0.25 percent of the value of shipment;
  
• 
  20-percent value added tax;
  
• 
  customs tariff tax which is 0% for most medical equipment.
  

Donated medical equipment is exempted from any customs duties.

The decision to allow certain medical equipment into the country is made on a case-by-case basis. The adequacy of any medical equipment brought into Moldova is assessed against an internal regulation of the Ministry of Health dealing with donated medical equipment. As a rule, the Ministry will allow into the country equipment less than ten years old (from the date of manufacture). The regulation sets the following requirements for medical equipment:

1. 
   It should be accompanied by documents certifying the origin, quality, name and type of item, name of producer, date of manufacture, date of installation, name of the institution that has been using the equipment, date of de-installation, whether or not the equipment is operational, technical specifications and warranty period;
   
2. 
   Any container should be accompanied by a document containing information on the number of packages, size, and weight;
   
3. 
   Information has to be provided for each package concerning the name and type of the item, manufacturer, number of items in the package, date of packaging;
   
4. 
   The cost of equipment has to be similar to the country of export or world level;
   
5. 
   Proper operational guides must be provided.
   

The market for used/refurbished equipment in Moldova is extremely limited. However, Moldovan public health institutions use some small amounts of used equipment which has been donated by institutions and individuals from overseas, including the United States. Although prices for used/refurbished equipment tend to be significantly smaller that those for brand new equipment, the paying ability of Moldovan public health providers is still very small. Private health institutions are few and account for only a small portion of the health services market. Most purchases made by public health institutions are made through public tenders.

Few medical equipment distributors exist in Moldova. The state-owned company Moldtehoptimed is the most important provider of medical equipment. Separate licenses which are issued by the Ministry of Health are required for each of the following activities:

1. 
   Dealing in medical equipment and
   
2. 
   Importation of medical equipment.
   

Morocco

General Market Condition: No Restrictions

Source: Report from CS Post (via E-Mail), 21 April 2003

Summary

Approximately 20 percent of the total imported medical equipment is used or reconditioned. It consists of heavy equipment such as X-ray machines, magnetic resonance imaging apparatus, ultrasonic scanning apparatus, patient monitoring systems (except medical equipment that require direct contact with internal organs), surgery equipment and operating tables, sterilization equipment, and bedding (except mattresses). This equipment is used by private hospitals, known as “clinics,” private specialty hospitals known as “centers,” such as radiology centers, cardiology centers, dialysis centers, and private testing laboratories. Reconditioned equipment with guarantees offers excellent opportunities.

Public Sector

Under the Moroccan regulations, the public sector is required to purchase medical equipment through tenders. Although no law forbids purchase of used equipment, tender documents often require procurement of new equipment. Three government entities provide healthcare and purchase medical equipment. These are the Ministry of Health (Ministère de la Santé), the National Social Security (Caisse Nationale de Securité Sociale—CNSS), and the Ministry of Defense (Ministère de la Defense). They respectively provide healthcare through “hospitals,” “polyclinics” and “military hospitals,” and they have independent budget and complete autonomy in purchasing medical equipment.

Regulatory Agency

The Ministry of Health is the government agency in charge of the Moroccan healthcare system.

Regulations

Under the Moroccan law 005/71 of October 12, 1971 on Protection against Ionization, import into Morocco of new or used radiology equipment requires a special authorization from the Center of Protection against Radiation of the Ministry of Public Health.

For used equipment, U.S. exporters must provide Moroccan buyers with the following:

• 
  Compliance certificate
  
• 
  FDA authorization
  
• 
  Technical documentation/directions for use of the product
  
• 
  Certification that the equipment is in good Electro-technical and radiological working order
  
• 
  Documentation/history on previous maintenance.
  

When a manufacturer or its agent has registered a medical device in Morocco, a third party cannot legally import the same device in used/refurbished condition without the used device being subjected to new safety inspections. For any piece of used/refurbished medical equipment that enters the country, the third party, as did the manufacturer or its agent, must provide the same as above, namely:

• 
  Compliance certificate
  
• 
  FDA authorization
  
• 
  Technical documentation/directions for use of the product
  
• 
  Certification that the equipment is in good Electro-technical and radiological working order
  
• 
  Documentation/history on previous maintenance
  

Import Documentation

Medical equipment and device other than radiation equipment requires approval from the Ministry of Health that the equipment meets Moroccan health standards. Morocco recognizes certifications provided by the FDA.

A commercial invoice is required. The commercial invoice should fully describe the goods in French. Certification as to country of origin is required. Payments are made through bank-to-bank irrevocable letters of credit. Pro-forma invoices must be provided in most cases. Invoices, which should be on company letterhead, are required for both import licenses and foreign exchange transfers. "To order" bills are acceptable as bills of lading.

Labeling Requirements

No special regulations apply to the exterior marking of containers for shipments to Morocco. Indication on outer containers of the net weight in kilograms, and other identification markings, will however assist in locating goods on arrival and speed their clearance through customs.

Import duties and taxes

There are no restrictions or tariffs that apply to used or reconditioned medical equipment. New or used medical equipment is subject to 2.5 percent import duties paid on ad valorem. There is a value-added tax of 20 percent paid on the compounded ad valorem and import duties.

Standards

Morocco uses the metric system exclusively and the 220 Voltage. Dates should have the date format dd/mm/yy. Literature in the French language is recommended.

Distribution

Foreign firms sell into the Moroccan market through distributors/agents. Agents/distributors are often necessary to assist the U.S. firm with documentation in the French language. Key to success in the used medical equipment sector lay in the technical support and warranty given to end-users of reconditioned medical equipment.