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 |
