Medical Device Registration in
Ministry of Health
Comision Federal para la Proteccion contra Riegos Sanitarios (COFEPRIS)
Medical Device Regulation
• General Health Law
• Health Law Regulations
• Official Mexicans Standards (NOMs)
- 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.
- 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).
- 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
- 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.