Miva Health has an effective regulatory and medical affairs team to register your product in the Mexican and Latin American territory in the fastest way and according to your needs.
Miva Health has an effective regulatory and medical affairs team to register your product in the Mexican and Latin American territory in the fastest way and according to your needs.
Our Medicines Regulatory Affairs Division will help you find the best submission route to register your product in Mexico and Latin America with a solid knowledge of local regulations. Medicine life cycle management includes changes over time that may include any modifications or updates to the registry. Our service includes advice to correctly import and classify the product.
New molecules are medications that contain an active ingredient that has not been previously used in Mexico, and their effectiveness, safety and therapeutic indication are not fully documented.
So they understand:
Medicines with an active ingredient of synthetic or semi-synthetic origin that has previously expired its patent, equivalent to the innovative medicine.
Medicines with an active ingredient produced from an extract of herbs, plants or fruits.
Medicines with an active ingredient product of biotechnology that has previously expired its patent, equivalent to the innovative medicine.
Medication for the treatment of rare diseases (less than five people per 10 thousand inhabitants).
Our Medical Device Regulatory Affairs Division will help you find the best submission route to register your product in Latin America with a solid knowledge of local regulations. Correct classification of risk level (I, II, III, IV) and category are essential to register and import your product.
