Requirements to obtain a Medical Device Sanitary Registration in Mexico are well established. However, such requirements imply that the Ministry of Health from the country of origin approves the device. In this article, we explore some cases when the product is not sold or approved in its country of origin and alternatives to register it in Mexico.
Before describing each case, it is worth mentioning the legal framework related to the country of origin requisite. Specifically, Article 180 of the Health Supplies Regulation allows to register in Mexico practically any medical device manufactured abroad. In the meantime, technical and administrative documents are provided. A critical prerequisite among them is to obtain a Certificate of Free Sales (CFS). By definition, a CFS is a document that endorses those medical devices approved for sale in the country of the National Regulatory Authority (NRA) issuing the document.
However, there are scenarios when the CFS cannot be received. Let us enlist the following cases:
Case I: Medical devices not considered as such in the country of origin
When a product is not considered as a medical device in the country of origin, but it is in Mexico, the NRA in the country of origin may be unable to issue the CFS. This is because that product is not subject to the scope of local regulations. A common example is hand sanitizers, which are not considered medical devices in most countries but in Mexico.
In such cases, COFEPRIS will generally require an explanatory letter from the NRA. In practice, we have found that manufacturers generally struggles to get such explanatory letters and even with those presented, COFEPRIS may not guarantee the approval of the product.
Case II: Medical devices not requiring approval in the country of origin
Depending on the regulations of each country, a product can be considered as a medical device but not require an authorization to be sold in the country of origin. Thus, the CFS is not granted.
A typical example is within the low-risk medical device group. In such scenarios, the probabilities to register in Mexico are higher (compared to the Case I) due to easier legal requirements.
Case III: Medical devices manufactured by third parties
In certain situations, multinational medical device companies establish manufacturing sites abroad to partially or fully elaborate their products. In such cases the approval is granted for the legal manufacturer but not for the real. This particular case is generally well processed through explanatory letters; in the meantime the legal manufacturer handles the CFS under its name.
In conclusion, though we have presented alternatives to register in Mexico a medical device without a CFS, not all the times such strategies are applicable. If you have any other case or need further details about the suggested strategies, feel free to contact us at firstname.lastname@example.org or check more information in our guidelines.