. /.  WORLD TRADE  
ORGANIZATION   
G/TBT/N/PRY/39 
7 December 2011 
 (11-6353) 
Committee on Technical Barriers to Trade Original:   Spanish 
  
 
NOTIFICATION 
 
The following notification is being circ ulated in accordance with Article 10.6. 
 
1. Notifying Member:   PARAGUAY 
If applicable, name of local government involved (Articles 3.2 and 7.2):  
2. Agency responsible:  
Dirección Nacional de Vigilancia Sanitaria  (National Health Monitoring Directorate) 
Ministerio de Salud Pública y Bienestar Social (MSP y BS)  (Ministry of Public Health and 
Social Welfare) 
Name and address (including telephone and fax numbers and e-mail and website 
addresses, if available) of  agency or authority designated to handle comments 
regarding the notification shall be  indicated if different from above:  
Ministerio de Relaciones Exteriores  (Ministry of Foreign Affairs) 
Centro de Referencia de la OMC  (WTO Reference Centre) 
Dirección de Organismos Económicos Multilaterales 
(Directorate of Multilateral Economic Organizations) 
Palma casi 15 de Agosto Nº 594 Asunción, Paraguay Tel.: +(595) 21-493 657 E-mail: snin@mre.gov.py  
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):   Medical products and 
in vitro diagnostic products. 
5. Title, number of pages and lang uage(s) of the notified document:   Resolución Mercosur 
N° 20/11, Reglamento Técnico Mercosur de  Buenas Prácticas de Fabricación de 
Productos Médicos y Productos para Diagnóstico de uso In Vitro (Derogación de las 
Res. GMC N° 04/95, 38/96, 65/96 y 131/96) (MERCOSUR Resolution No. 20/11, 
MERCOSUR Technical Regulation on good ma nufacturing practices for medical products 
and in vitro diagnostic products (Rep eal of MERCOSUR Common Market Group 
Resolutions Nos. 04/95, 38/96, 65/96 and 131/96)) (21 pages, in Spanish) G/TBT/N/PRY/39 
Page 2  
 
  6. Description of content:   The notified Technical Regulation establishes manufacturing 
requirements for medical products and in v itro diagnostic products.  The requirements 
concern good manufacturing practices (GMP) re lating to the methods and monitoring 
procedures used in the design, purchase, ma nufacture, packaging, labelling, storage, 
distribution and installation of medical products  and in vitro diagnostic products, and the 
technical assistance provided in respect of such  products.  The requirements seek to ensure 
the safety and effectiveness of the products concerned. 
7. Objective and rationale, including the nature of urgent problems where applicable:  
Protection of human health and prevention of deceptive practices. 
8. Relevant documents:   Decreto Nº 17057/97 Por el cual se dispone la vigencia en la 
República del Paraguay de las Resoluciones adoptadas por el Gru po Mercado Común del 
MERCOSUR, referentes a Reglamentos Técnicos  (Decree No. 17057/97 providing for the 
validity in the Republic of Paraguay of the Resolutions adopted by the MERCOSUR 
Common Market Group in respect of Technical Regulations) 
Decreto Nº 10.116/00 Por el cual se dispone la  vigencia en la República del Paraguay, de 
las Resoluciones aprobadas por el Grupo Mercado Común del MERCOSUR, referentes a 
Reglamentos Técnicos de Productos para la Salud  (Decree No. 10.116/00 providing for the 
validity in the Republic of Paraguay of the Resolutions adopted by the MERCOSUR 
Common Market Group in respect of Technical  Regulations concerning health products) 
9. Proposed date of adoption: 
Proposed date of entry into force:  } 2012 
10. Final date for comments:   - 
11. Texts available from:  National enquiry  point [ ] or address, telephone and fax 
numbers and e-mail and website addresses, if available, of other body: 
Unidad de Coordinación del SNIN 
Ministerio de Industria y Comercio (MIC) 
Avda. Mariscal F. López 3333 
Asunción, Paraguay Tel.: +(595) 21-616 3284 Fax: +(595) 21-616 3084 E-mail: snin@mic.gov.py  
Also available online at: 
http://members.wto.org/crnattach ments/2011/tbt/PRY/11_4123_00_s.pdf