G/TBT/N/PER/ 93 
 
8 May 2017  
(17-2461) Page: 1/2 
Committee on Technical Barriers to Trade  Original:  Spanish  
 
 NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6.  
 
1. Notifying Member:  PERU  
If applicable, name of local government involved (Articles 3.2 and 7.2):     
2. Agency responsible:  Ministerio de Salud  (Ministry of Hea lth) 
Name and address (including telephone and fax numbers and email 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 
Comercio Ext erior y Turismo , MINCETUR (Ministry of Foreign Trade and Tourism)  
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 prov ided in addition, where applicable):  Medical 
devices classified under Chapter 30 of the Harmonized System or Customs Tariff  
5. Title, number of pages and language(s) of the notified document:  Proyecto de 
Reglamento que establece las reglas de clasificació n y los principios esenciales de 
seguridad y desempeño de los dispositivos médicos  (Draft Regulation  establish ing the 
classification rules for and the  essential principles of safety and performance of medical 
devices ) (34 pages, in Spanish)  
6. Description  of content:   
The aims of the notified draft Regulation are as follows : 
 to establish the rules governing the classification of medical devices by risk level, 
pursuant to  Article  6.2 of Law  No. 29459 (Law on pharmaceutical products, medical 
devices and sani tary product s), for sanitary registration  purposes ;    
 to establish the essential principles of safety and performance to be respected  by the 
manufacturers of  medical devices  in order to demo nstrate that  such products are safe 
and perform  in accordance  with the manufacturer 's intended end use .  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of human health   
8. Relevant documents:   
1. Ley N° 29459 - Ley de los Productos Farmacéuticos, Dispositivos Médicos y  Productos 
Sanitarios  (Law No. 29459 - Law on pharmaceutical products, medical devices and 
sanitary products);  
2. Decreto Supremo N° 016 -2011-SA, Reglamento para el Registro, Control y Vigilancia 
Sanitaria de Productos Farmacéuticos, Dispositivos Médicos y  Productos Sanitarios  
(Supreme Decree No. 016 -2011-SA, Regulations on the registration, control and sanitary 
surveillance of pharmaceutical products, medical devices and sanitary products).  G/TBT/N/PER/ 93 
 
- 2 - 
 
  9. Proposed date of adoption: 180 calendar days after publication  in the Official Journal 
El Peruano  
Proposed date of entry into force: 180 calendar days after publication in the Official 
Journal El Peruano  
10. Final date for comments:  2 August 2017   
11. Texts available from:  National enquiry point [ X] or address, tel ephone and fax 
numbers and email and website addresses, if available, of other body:   
Ministerio de Comercio Exter ior y Turismo,  MINCETUR  
Calle Uno Oeste Nº 50, Urb. Corpac, Lima 27,  Perú 
Tel.: (+51-1) 513 -6100, Ext. 1223 o r 1239 
E-mail: otc@mincetur.gob.pe  
Website:  
http://extranet.comunidadandina.org/sirt/public/index.aspx  
http://www.mincetur.gob.pe/reglamentostecnicos  
http://www.digemid.minsa.gob.pe  
https://members.wto.org/crnattachments/2017/TBT/PER/17_2183_00_s.pdf