G/TBT/N/PER/123  
2 July 2020 
(20-4580) 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 , MINSA (Ministry of Health)  
Av. Salaverry 801 , Jesús María, Lima, Peru  
Tel.: (+51-1) 315 -6600 
Email: webmaster@minsa.gob.pe  
Name and address (including telephone and fax numbers, 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 Exterior y Turismo , MINCETUR (Ministry of Foreign Trade and 
Tourism)  
Calle Uno Oeste  Nº 50 - Urb. Corpac - Lima 27 - Peru 
Tel.: (+51-1) 513 -6100, Ext. 1223 or 1239  
Email: otc@mincetur.gob.pe  
3. Notifie d 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 
devices ; Glands and other organs for organo -therapeutic uses, dried, whether or not 
powdered ; extracts of glands or other organs or of their secretions for organo -therapeutic 
uses; heparin and its salts ; other human or animal substances prepared for therapeutic or 
prophylactic uses, not elsewhere specified or included (HS 3001) ; Human blood ; animal 
blood prepared for therapeu tic, prophylactic or diagnostic uses ; antisera, other blood 
fractions and immunological products, whether or not modified or obtained by means of 
biotechnological processes ; vaccines, toxins, cultures of micro -organism s and similar 
products (excluding yeas ts).(HS 3002) ; Medicaments (excluding goods of heading 30.02, 
30.05 or 30.06) consisting of two or more constituents which have been mixed together 
for therapeutic or prophylactic uses, not put up in measured doses or in forms or packings 
for retail sale ( HS 3003) ; Medicaments (excluding goods of heading 30.02, 30.05 or 30.06) 
consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in 
measured doses (including those in the form of transdermal administration systems) or in 
forms or packings for retail sale (HS 3004) ; Wadding, gauze, bandages and similar articles 
(for example, dressings, adhesive plasters, poultices), impregnated or coated with 
pharmaceutical substances or put up in forms or packings for retail sale for medical, 
surgical, dental or veterinary purposes (HS 3005) ; Pharmaceutical goods specified in Note 
4 to Chapter 30 and included in subheadings 3006.10.10 to 3006.60.90 (HS 3006)  G/TBT/N/PER/123  
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  5. Title, number of pages and language(s) of the notified document : Proyecto de 
Reglamen to que Regula los Cambios en el Registro Sanitario de los Dispositivos Médicos  
(Draft Regulation governing changes  to medical devices  in the sanitary register) (5 pages, 
in Spanish)  
6. Description of content : The notified draft Regulation provides for maj or and minor 
changes in the sanitary register, as they may have repercussions on the quality, safety and 
effectiveness of medical devices, and establishes the conditions and documents required 
for such changes.  
7. Objective and rationale, including the nature of urgent problems where 
applicable : Protection of human health ; Protection of human health or safety  
8. Relevant documents:  
1. Ley N° 29459 , Ley de los Productos Farmacéuticos, Dispositivos Médicos y Productos 
Sanitarios ; 
2. Decreto Supremo N° 016 -2011/SA, Reglamento para el Registro, Control y Vigilancia 
Sanitaria de Productos Farmacéuticos, Dispositivos Médicos y Productos Sanitarios . 
9. Proposed date of adoption : To be determined  
Proposed date of entry into force : Six months after  publication in the Official Journal El 
Peruano . 
10. Final date for comments : 30 August 2 020 
11. Texts available from : National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available, of other body:  
Ministerio de Comercio Exterior y Turismo  (MINCETUR)  
Calle Uno Oeste Nº 50 - Urb. Corpac - Lima 27 - Peru 
Tel.: (+51-1) 513 -6100, Ext. 1223 or 1239 
Email: otc@mincetur.gob.pe  
Ministerio de Salud  (MINSA)  
Av. Salaverry 801 , Jesús María, Lima , Peru  
Tel.: (+51-1) 315 -6600 
Email: webmaster@minsa.gob.pe  
http://consultasenlinea.mincetur.gob.pe/notificaciones/Publico/FrmBuscador.aspx  
http:// extranet.comunidadandina.org/sirt/public/index.aspx  
https://www.gob.pe/institucion/minsa/normas -legales/702071 -395-2020-minsa  
https://members.wto.org/crnattachments/2020/TBT/PER/20_4003_00_s.pdf