REGISTRATION

TYPES OF REGISTRATION (DIOPSA)

EMB EVERYTHING MUST BE REGISTERED WITH THE MINISTRY OF HEALTH COSTA RICA

CLASS OR RISK LEVELS BY TYPE OF EMB

Legal regulation of the Registry in Costa Rica

Prior to 2005 Costa Rica was forced to record all medicines, cosmetics and food to the Minister of Health, as far as it related to DIOPSA.
Also from this year starts regulating the entry of equipment and biomedical materials (EMB). The EMB are valid for 5 years and then must be renewed.

The requirements for each class are listed below:

» Requirements for Registration of EMB

APPLIES TO CLASSES

Present Certificate of Free Sale	1, 2, 3, 4
Present the specific medical	1, 2, 3, 4
List of countries where the product is marketed	3, 4
Submit Monitoring Program	3, 4
Submit clinical trials demonstrate the safety and efficacy of EMB	3, 4
If your product requires sterilization must submit the required method for such sterilization.	3, 4
Submit the study of risk analysis and assessment of EMB and due measures to reduce.	3, 4

LEGAL

This unit reviews the contracts that manufacturers send us, we seek a balance between the conditions for a contractual relationship that will allow sales to continue work in all divisions of the Company.
Currently required for the commercialization of biomedical equipment and materials to both public and private sector, the legal knowledge to regulate the relationship between manufacturers and retailers when they purchase required, and to regulate the relationship between dealer and buyer user. Manufacturer chief gets all the goods and equipment supplied to users. In the case of public sector regulations are consistent, they must know and stay up to date and that the omission of some of them may lead to disqualification of the bid on a particular contest. In the private sector the situation is similar, but the negotiation is personal and legal details are handled in agreement, while in the public sector the government is required and the provider must generally conform to them.

The Legal support in this market segment is imperative because of the strong interests involved in every trade:

Each party wants the maximum benefit.
The manufacturer always wants the biggest advantages.
The dealer must protect their rights and express their worth, requiring agreement provided.