. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/CRI/71 
20 December 2007 
 (07-5694) 
Committee on Technical Barriers to Trade Original:   Spanish 
  
 
NOTIFICATION 
 
The following notification is being circ ulated in accordance with Article 10.6. 
 
1. Member to Agreement notifying:   REPUBLIC OF COSTA RICA
 
If applicable, name of local government involved (Articles 3.2 and 7.2):         
2. Agency responsible:  
Ministerio de Economía, Industria y Comercio  
(Ministry of the Economy, Industry and Trade) 
Órgano de Reglamentación Técnica  
(Technical Regulation Body) 
Tel.:  (+506) 235 2700, ext. 221 or (+506) 236 25 38 
Name and address (including telephone and fax numbers, e-mail and web-site 
addresses, if available) of  agency or authority designated to handle comments 
regarding the notification shall be  indicated if different from above:  
TBT Inquiry Point 
Ministry of the Economy, Industry and Trade (MEIC) Apartado Postal. 10216-1000 Tel.: + (506) 235 2700, ext. 206/203 Fax: + (506) 297 1439 E-mail: crotc@meic.go.cr  
Web site: http://www.reglatec.go.cr 
3. Notified under Article 2.9.2 [  X ], 2.10.1 [   ], 5.6.2 [   ], 5.7.1 [   ], other:         
4. Products covered (HS or CCCN where applicable, otherwise national tariff heading.
ICS numbers may be provided in addition, where applicable):   International 
Classification for Standards (ICS) code 67.080 
5. Title, number of pages and language(s) of the notified document:   RTCR 405:2007 
Reglamento para Registro, Clasificación, Impor tación, y Control de Equipo y Material 
Biomédico  (Costa Rican Technical Regulation (RTCR) No. 405:2007 Regulations for the 
Registration, Classification, Importation and Inspection of Biomedical Equipment and Material) (19 pages, in Spanish). 
6. Description of content:   The purpose of these regulations is to establish the requirements 
and procedures necessary for the classification, registration, importation and inspection of 
biomedical equipment and material (BEM) intended for human use. G/TBT/N/CRI/71 
Page 2  
 
  7. Objective and rationale, including the nature of urgent problems where applicable: 
The regulations provide for the effective inspection of BEM and for their operation, 
importation and commercial use by registered enterprises or persons, respecting basic human rights and guaranteeing the protection of human health. 
8. Relevant documents:  
- Article 140.3 and 140.18, and Article 146 of the Constitution of Costa Rica; 
- Article 27.1 of the General Public Administration Law; 
- Articles 1, 2, 4, 7, 49, 142, 143, 1 44 and 145 of Law No. 5395 of 30 October 1973 
("General Law on Health"). 
9. Proposed date of adoption: 
 
Proposed date of entry into force:  Upon publication in the Official Journal ( La 
Gaceta ). 
Applicable as of the date of publication in the 
Official Journal. 
10. Final date for comments:   60 days as of the date of notification 
11. Texts available from:  National enquiry point [  X ] or address, telephone and fax 
numbers, e-mail and web-site addresses, if available of the other body: 
 Centro de Información OTC  (TBT Enquiry Point) 
Internet site: http://www.reglatec.go.cr WTO Contact point: crotc@meic.go.cr San José, Costa Rica Tel.: (+506) 235 2700, Ext.221 
Fax: (+506) 297 1439 or (+506) 236 7192 
 Full text available online at: http://www.reglatec.go.cr/propuestas/RT_EMB_para_OMC_con_ultimas_observaciones. pdf