Medical devices and in vitro diagnostic medical devices in Mexico comply with the Mexico standard NOM-241-SSA1-2021. Mexico is classified into Class I, Class II, and Class III depending on risk, and all medical devices and in vitro diagnostic medical devices must be registered mandatory sanitary registration.
The regulatory authorities related to medical devices and in vitro diagnostic medical devices in Mexico are as follows.
- Ministry of Health, Responsible for evaluating, managing and monitoring medical devices
- Cofepris, Certification of essential products for export and distribution of medical devices
- IMSS (Instituto Mexicano del SeguroSocial), Responsible for the prevention, diagnosis, treatment of diseases and injuries
Medical devices and in vitro diagnostic medical devices are classified into three categories depending on the purpose of use: medical equipment, artifacts, and diagnostic objects.
The documents submitted when applying for sanitary registration are briefly listed below.
<Application document submission items>
1. Certificate of Free Sale
2. letter of representation
3. GMP certificate
4. power of attorney for the legal representative of the company
<Technical document submission items>
- Technology and information on the safety and effectiveness of medical devices
- Mexico Standard NOM-137-SSA1-2008, Spanish labels according to medical device labeling
- Leaflet or user manual in Spanish
- General description of the manufacturing process
- Reference list
- Information about the sterilization process
- Research reports (research reports on diagnostic groups for evaluating hepatitis C, hepatitis B, surface antigen, blood typing serum, HIV/AIDS, and condoms)
Sanitary registration certificates are valid for five years, and applications for registration renewal must be submitted 150 days before expiration.
Please refer to the link below for details.
Registro sanitario de dispositivos médicos de fabricación | gob.mx (www.gob.mx)
gob.mx
El portal único del gobierno.
www.gob.mx
If you have any questions about medical device certification,
Please contact us with the below.
info@jnmglobal.net
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