Peru

General

Country: Peru
Geographic region: Latin America
Income level (World bank): Lower middle income
Are condoms (male/female) regulated in the country? yes
If yes, describe the applicable regulation or directive: DIGEMID. Decreto supremo 016-2011, Ley 29459*
Condom classification (medical device, medicines, others): Law 29459.Classified as medical device class II
National competent (regulatory) authority: DIGEMID - MINSA

Essential Medicines List

Condoms on EML? no
Female condoms specified on EML? no

Registration Requirements

Administrative documents: Fill and sign the application form, import documents
Technical documents: GMP (CE, WHO PQ, FDA),technical studies, risck managment policy, safety and eficacy studies,
Process: Evalluation comitee of DIGEMID aproves the process
Timeline: 90 days after acceptance of dossier and payment of fees
Registration Fee: $ 365
Validity of registration: 5 years
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