If you are a medical devices manufacturer and are interested in selling / importing your medical devices to Mexico, then you want to continue reading.

Medical devices are described under the General Health Law in Mexico and includes the following products:

– Medical equipment

– Prothesis, orthosis and functional aids

– Reactives, diagnostic agents and IVDs

– Odonthological supplies

– Surgical and healing supplies (medical materials)

– Hygienical products

Medical devices require a registration (Marketing authorization) that is valid for 5 years and can be renewed, and sometimes requires importation permit after registration for each importation.

In order to register a medical device in Mexico, you need to comply the following in order to be eligible to be a registration holder in Mexico, and make a registration application:

1. You need to be a legally established company in Mexico with a legal representative with permanent residence in Mexico
2. You need to have an operational warehouse with a quality system (SOPs) – notified in MoH, The Mexican Pharmacopeia describes the infrastructure you need for a health supplies warehouse, and basically it needs to be an independent warehouse from other companies and different classification of products.
3. Also you need a Sanitary responsible also called technical director that can be a Pharmacist, biomedical engineer or chemist – notified in MoH
4. Finally you need to have a technovigilance unit with a technovigilance responsible – notified in MoH

If you are not ready to develop your own infrastructure, Rafconsulting can act as your Mexican Registration Holder (MRH) for your registrations in Mexico. Please contact us for more information.

Once you comply with the company’s requirements to register medical devices, then you can proceed to the registration application for your medical device:

The general requirements for registration are the following:

1. Free sale certificate (FSC) issued by the Health Authority from the Country of Origin or clinical trials performed in Mexico. Legalized original.
2. GMP certificate or ISO 13485 for every facility involved in the process (Manufacturing, sterilization, packaging, etc.) Legalized original
3. Representation letters or Power of attorney naming holder and distributors (issued by manufacturer) Legalized original.
4. Technical dossier: must document every step from design, materials, manufacturing, finished product, stabilities, performance, etc. You need to demonstate quality, safety and efficacy, and detailed evidence is required.
5. Original Certificate of Analysis or Conformance.
6. Everything must be submitted in Spanish and organized according to Cofepris Criteria.

In Rafconsulting we will be happy to help you determine the requirements for your specific product, we can help you with all that you need to register, import and sale your medical devices in Mexico, please contact us for more information.

We will be discussing in the future the specific requirements for registrations, among other updates on the regulation, to be up to date, please subscribe to our newsletter, link on the footer.