Medical Device Regulatory Requirements in Peru

Regulatory Authority DIGEMID
Regulatory Authority Website Link Click Here
Device Classification I,II,III,IV
Medical Device Regulations Supreme Decree No 016-2011-SA Regulations | Click Here
Registration Process Medical Device Registration | Click Here
Registration Timeline For low-risk devices, it takes 2 to 3 months and for high-risk devices, it takes 5 to 6 months
Requirement of Authorized Representative YES
Language Requirement Labels must be in Spanish Language
Advertising and Promotions
  • Technical Health Standard that establishes the Ethical Criteria for the Promotion and Advertising of Pharmaceutical Products, Medical Devices, and Health Products.
| Click Here
Additional Information

The license validity for medical device registration in Peru is 5 years.
Disclaimer: This website sources information from regulatory authorities and aims for accuracy, but regulations may change without notice. Users are advised to verify details with relevant authorities before making compliance decisions. We are not responsible for errors, omissions, or outdated content.

The above information is last updated on 09/May/2025

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