. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/ARG/203 
27 September 2006 
 (06-4601) 
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:   ARGENTINA
 
If applicable, name of local government involved (Articles 3.2 and 7.2):    
2. Agency responsible:   Administración Nacional de Alimentos, Medicamentos y Tecnología 
Médica , ANMAT (National Food, Drug and Medical Technology Administration). 
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:   National enquiry 
point. 
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 technology 
products. 
5. Title, number of pages and language(s) of the notified document:   "Registro de 
Productores y Productos de Tecnología Médica " – Procedimientos para la solicitud de 
inscripción " (Register of Medical Techology Pr oducers and Products – Procedures for 
Registration Applications) (98 pages, in Spanish). 
6. Description of content:   The text sets out the procedures for applying for registration in the 
Register of Medical Technology Producers a nd Products (RPPTM);  forms for initiating 
RPPTM registration procedures for each of the procedures classified;  applications for 
inclusion in the Register of class I, II, III,  and IV medical products and details of the 
required accompanying documentation;  model in structions on the use of medical and other 
products. 
 Companies manufacturing and importing me dical products shall be required to 
adapt their product labels within twelve (12) mont hs from the date of entry into force of this 
Resolution, by including on them the condition of sale. 
 The Directorate of Medical Technology shall publish non-binding guidelines on its 
web site, for the benefit of the regulated  industry, concerning the practices and 
methodologies recommended to facilitate th e processing, content and assessment of 
applications that come within its purview;  the design, production and testing of regulated 
products and inspection an d auditing procedures. G/TBT/N/ARG/203 
Page 2  
 
  7. Objective and rationale, including the nature of urgent problems where applicable: 
" ... the procedure for registering medical produc ts consists in verification by the competent 
authority that the applicant has complied w ith the internal requirements concerning risk 
analysis, design checks and controls, produc tive processes and quality assurance, which 
make it possible to foresee possible flaws having an impact on product safety and 
efficiency, and to implement the necessary corrections to the design specifications, 
minimizing the risks for the patient or user, fo r the operator and for third parties involved in 
the use of the medical product ... as all these corrections are to be implemented directly by the company concerned or by third parties acting on behalf and on the instruction of the latter, under its exclusive respons ibility, it is necessary to standa rdize the assessment criteria 
and the evidence which the implementing au thority shall be required to assess for the 
purpose of verifying compliance with the requirements set out in the applicable 
regulations." 
8. Relevant documents:   ANMAT Resolution No. 5267/2006 
9. Proposed date of adoption: 
Proposed date of entry into force:   27 September 2006 
Not indicated 
10. Final date for comments:   Not indicated 
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: 
Punto Focal de la República Argentina 
Dirección Nacional de Comercio Interior Avda. J. A. Roca 651 Piso 4° Sector 2 (C1067ABB) Buenos Aires 
Tel.:  (+54) 11 4349 4067 
Fax:  (+54) 11 4349 4072 E-mail:  focalotc@mecon.gov.ar Text available at: http://www.punt ofocal.gov.ar/notific_arg.htm