Mandala International, the key to your success in Peru!
WHAT WE DO
OUR SOLUTIONS
Mandala aims to act as your trusted commercial partner and third party.
Mandala will handle the registration of your products, provide guidance on applicable certifications, act as your legal regulatory representative in the country, and ensure the maintenance of your registrations and all post-registration regulatory activities in compliance with applicable legislation (post-market surveillance, technical and administrative changes, renewals, etc.).
In addition to being your partner for product registration and certification, Mandala will support you with the legal establishment of your company, including obtaining operating authorizations (local health permits), as well as developing quality management procedures.
In this way, Mandala takes care of the regulatory and administrative requirements, while you remain fully independent and autonomous, free to choose your own partners to commercialize your products in the country.
DIGEMID
PRODUCT REGISTRATION
Products intended for the human healthcare sector must be registered with DIGEMID before being marketed. Mandala has extensive knowledge of the interpretation of Peruvian laws, practices, and regulatory requirements to support you with the registration of the following products:
- Cosmetics
- Medical devices
- Disinfectants
- Medicines
- Food supplements
DIGEMID GENERAL GUIDELINES:
- Registration must be submitted by a Peruvian company.
- The company must hold the health licenses required by DIGEMID.
- The registration or notification is valid for a minimum of 5 years.
- The registration or notification process takes approximately 3 to 6 months, depending on the risk classification applicable to the product.