Ministry of Health

Secretary of Health(SALUD)

Regulatory Authority

Comision Federal para la Proteccion contra Riegos Sanitarios (COFEPRIS)

Medical Device Regulation

• General Health Law

• Health Law Regulations

• Official Mexicans Standards (NOMs)

Official Language

Spanish

Classification

Class I/II/III

Registration Process

• Appoint a Mexico Registration Holder (MRH) who will coordinate device submissions.
• Demonstrate home country approval through Certificate of Free Sale (CFS) or Certificate to Foreign Government (CFG).
• The device must comply with ISO 13485 or equivalent in another country. No audit will be performed.
• Submit a registration dossier, which should include safety information, testing reports, and clinical trial data. Approval from the recognized countries (Japan, Canada, or United States) may be leveraged in order to expedite approval.
• If the device is approved COFEPRIS will issue a certificate and post confirmation of device registration on the Ministry of Health website.

Documents Required

• Technical documents
• Draft label, IFUs in Spanish
• General description of the manufacturing process
• Product Description
• Testing reports verifying the specifications of the medical device
• Free sale certificate
• Letter of Authorization & Power of Attorney
• QMS certificate
• Certificate of Analysis or declaration of conformity issued by manufacturers
• Notice of operation and sanitary responsible
• Copies of approval in reference countries ( FDA for US or Health Canada for Canada or MHLW for TGA).

Applicable QMS

ISO 13485

Registration Timeline

• Standard Route: 3-6 months
• Expedited Route (Third Party Route-TPR): 2-5 months
• Equivalency Route (Applicable for all medical devices approved in the US, Canada, and Japan): 3-8 months

Authorized Representative

Yes

License Validity

5 years

Special Notes

• Labelling must be in Spanish
• In addition to the registration certificate, an import permit is also required for products such as Class III and implantable devices. Translation to Spanish is no longer mandatory for technical documents that are provided in English.
• All documents included in the registration dossier shall be translated in Spanish.