Obtaining the Sanitary Registration for a product in Mexico requires to consider different regulatory pathways. In knowledge of this circumstances, COFEPRIS made a distinction between products already widely recognized and sold in the market, giving that selection of products the title of Class I Low-Risk, as to reduce the regulatory hurdles in order to obtain the registration.
Making your regulatory experience more amicable, we prepared a checklist detailing all the necessary documents for the Class I Low-Risk process. However, given the essence of the regulatory knowledge needed to comprehend this type of requirements, you could end up in a predicament trying to understand what the requirements actually are.
In this article, we aim to give a more detailed, bite-sized orientation for each one of the items noted in our Class I – Low Risk registration process checklist, hoping to give a more readily available explanation.
If you need to review the validity (to review which medical devices classify as Class I Low-Risk Medical Devices) of the agreements related to this article, we encourage you to check this publication: Low Risk And Non-Regulated Medical Devices.
Application Form and Payment of Fees
The application form is the basis to submit any new low-risk medical device registration. It serves as an entry point for your registration process, detailing to COFEPRIS what type of service do you require from it. It also must be accompanied by the payment of the corresponding fee, compliant with the type of service you are requesting.
It also needs to be duly signed by a representative of the Mexican Registration Holder (MRH).
Warehouses Notice (Aviso de Funcionamiento) for the Mexican Registration Holder and for all the distributors in Mexico mentioned in the sanitary registration
The Warehouses Notice serves as a sort of acknowledgement that you are conscious and willing to participate within the Mexican regulatory framework. This notice provides details about your designated MRH and distributors –as also including the information of the people responsible for compliance as representatives of the companies and their respective Sanitary Responsible.
Power of Attorney, issuing authority to the legal representative to apply for renewals and/or registration submissions to COFEPRIS
This document consists of a written statement in which the manufacturer recognizes and officially appoints a company and/or a person as the legal representatives in Mexico, to act on your behalf in managing all your regulatory affairs before COFEPRIS regarding your products.
As the document has a legal significance, it is necessary to submit the top copy of the document, or a certified copy by a Mexican notary, and duly authenticated. Also, as per the most recent decree emitted in regards to translations, the document can be submitted in both English and/or Spanish (except for labels and manuals or instructions for use). If the document is written in any other language, a translation to Spanish made by an authorized translator must be submitted along with the document.
Labels (that will be used for products imported to Mexico) & Label design (Based on the Mexican norm information requirements)
The term “label” encompasses any tag, inscription, or graphic image displayed on the medical device or in its container. The term “label design” refers to a document that contains all of the information on the actual label of the device and any pertaining information that is needed in order to fulfill the necessary regulatory requirements.
Instructions for use (in Spanish)
The Instructions for Use (IFU) is a written document that contains critical information regarding your product. Typically, the IFU should contain detailed, action-oriented, step-by-step written and visual instructions provided in a patient-friendly manner. In some instances, this information must be complemented with specifications of your product, or with additional information such as handling, storage, disposals, tests, etc.
If the IFU designed for the device is written in more languages other than Spanish, it is necessary to translate it. This is also applicable for manuals.
For any company to act as your Mexican Registration Holder: Original or certified copy of the Representation letter issued by the manufacturer
Also known as a Letter of Authorization (LoA) or Letter of Representation, this document is a valid legal agreement between two parties in which one party (in this case, the company aiming to sell its product in Mexico) acknowledges its designated companies, filial, subsidiaries or partners and endows them with the appropriate attributions to act on its behalf.
As a rule of thumb, a general recommendation is to bestow the following attributions (as needed) to your legal representatives and/or selected distributors: importing, distributing, selling, acting on behalf of the company before COFEPRIS, and any others deemed necessary.
To comply with this part of the registry process, you need to submit the top copy of the document, or a certified copy by a Mexican notary. The document also needs to be duly authenticated. Also, as per the most recent decree emitted in regards to the language of the documentation, the document can be submitted in both English and/or Spanish. If the document is written in any other language, a translation to Spanish made by an authorized translator must be submitted along with the document.
Original or Certified Copy of the Distribution letter for each distributor that you are appointing to the registration
As in the previous item, a Distribution Letter is a valid legal agreement between two parties, but this time it is specific for the Mexican distributors acting to distribute and/or sell the registered product.
In this case, the common attributions conferred to the distributors are only to import, sell and distribute the product, though in various cases more attributions may be written into the document.
As stated in the item above, to comply with this part of the registration process, you need to submit the top copy of the document, or a certified copy by a Mexican notary. The document also needs to be duly authenticated. Also, as per the most recent decree emitted in regards to the language of the documentation, the document can be submitted in both English and/or Spanish. If the document is written in any other language, a translation to Spanish made by an authorized translator must be submitted along with the document.
Conclusions
The path to register a Low-Risk Medical Device in Mexico is typically a more straightforward journey than their Class I, II or III counterparts, given the regulatory convenience that COFEPRIS gives to this type of process.
Nevertheless, each point may have divergences from the recommended practices given the own nature of the products to be registered. If you need support explaining any one of the requirements described in this article, please contact us at contact@veraqueconsulting.com or check our guidelines or checklists.
