Mexico's Ministry of Health (SecretarÃa de Salud, SSA) generally requires foreign companies to appoint a local authorized representative when registering and selling drugs, medical devices, or other related products in Mexico. This local representative is often called:"responsable sanitario", that is, the person in charge of hygiene. Here's some information on why you need a local authorized representative and what their responsibilities are:
1.Regulatory Compliance:The Mexico SSA requires that products sold in Mexico comply with the country's regulations and standards. The presence of a local authorized representative helps to ensure that the foreign company complies with local regulations and assists in its communication with the SSA.
2.Quick response:Local authorized representatives are typically required to provide an address and contact information within Mexico so that SSA can contact them directly if necessary. This helps speed up problem resolution and reduces potential delays.
3.Document Submission and Approval:A local representative may need to assist with the submission of registration documents and work with SSA to ensure that the approval process for documents is smooth. They may need to have a certain professional background to better understand and interpret product information.
4.Emergency Handling:In the event of an emergency, a local representative may need to coordinate with SSA to assist with resolving issues and ensuring product safety and compliance.
5.Indicates legal responsibility:A local authorized representative is the legal representative of the company in Mexico and has certain legal responsibilities. They may need to ensure that the company's products comply with local regulations to avoid potential legal liabilities.
It is important to note that these regulations may change over time and as regulations change, so it is best to check with the SSA or a professional legal advice firm for the latest requirements before making an application. Choosing the right local authorized representative is one of the important steps to ensure that your products are successfully registered and sold in Mexico.