A Letter of Authorization (LoA), also known as Letter of Representation, is a type of agreement between two companies in which one authorizes the other to perform certain activities and get responsibilities on behalf of the first company. In this article, we will explain the use of LoAs for the Medical Device industry in Mexico.
LoAs are an essential requirement to register a medical device in Mexico. This document must be issued by the Manufacturer of the medical device on favor of the Mexican Registration Holder (MRH) or local importer/distributor.
According to the Regulation on Health Supplies Articles 161 and 180, LoAs must have the following requirements:
- Only required when products are not manufactured in Mexico.
- Need to be authenticated in the country of origin through Legalization or Apostille.
Additionally, it is recommended that LoAs include the following points:
- Include the manufacturer’s name and address. It is suggested to be mentioned exactly as in the GMP (Good Manufacturing Practice) Certificate.
- Indicate the MRH and/or importer/distributor legal name and address as appears in the tax ID.
- List the activities that the manufacturer authorizes the MRH and/or importer/distributor to do, such as: importation, distribution, storage, marketing, participation in tenders, service, being able to participate in registrations and other regulatory procedures in COFEPRIS.
- It can be related to all the manufacturer products or certain devices.
- May appoint the MRH and/or importer/distributor as exclusive or non-exclusive distributor.
- Should include the date of issuance and validity (typically 5 years)
- Must include the manufacturer letterhead and be signed by a person with authority to sign contracts (Owners, Directors, Managers, etc.)
- The LoA is then Notarized and authenticated in the country of origin
- Can be in Spanish or other language.
Conclusions
LoAs are key documents issued by foreign manufacturers to allow companies in Mexicco to register or distribute medical devices. These documents must accomplish legal requirements and consider additional points to have control of registrations and sales. If you need help building your letter of representation please contact us at contact@veraqueconsulting.com
