Mandala International, the key to your success in Mexico!
WHAT WE DO
Mandala International aims at acting as a commercial and third partner on trust matters.
Mandala will take care of the records of your products, provide the advisory service for applicable compliance certifications (IVD or laboratory tests for drugs), will be your legal regulatory representative in the country, it will guarantee the maintenance of your records and post-registration regulatory actions in compliance with applicable law (sanitary surveillance, technical and administrative modifications, renewal,…).
In addition to being your partner in the certification of your products, Mandala will support you in the legalization processes of your company with the operating authorizations (Mexican sanitary license), as in the preparation of the quality management process.
Thus, when you have decided to advertise in the country, Mandala had accompanied you in the adequacy and compliance of the marketing supports chosen with the applicable rules of COFEPRIS.
Finally, Mandala shall take care of regulatory and administrative requirements, while you remain independent and autonomous, and can choose your partners for marketing your products in the country.
To be marketed in Mexico, it is necessary for health products to be registered by COFEPRIS. Among the products that need registration or annotation are:
– Medical devices;
– Sanitizing products;
COFEPRIS’ GENERAL GUIDELINES:
– Registration needs to be required by a Mexican company;
– This company needs to have the sanitary licenses required by COFEPRIS;
– The registration is kept for 5 years;
– The registration process lasts an average of 12 months, depending on the risk class applicable to your product.