PER/123
WTO/TBT
PE Peru
  • 11 - Health care technology
  • 30 - Pharmaceutical products
2020-08-30
2020-07-23

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 therapeutic, 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-organisms and similar products (excluding yeasts).(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)

Proyecto de Reglamento 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)

The notified draft Regulation provides for major 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.