In order to market a Medical Device (MD) in Mexico, it is required to have a Sanitary Register issued by the Federal Commission for the Protection Against Sanitary Risks (COFEPRIS).
But what is a Sanitary Register? A sanitary register is a sanitary authorization, that is, it is the administrative act by which the competent sanitary authority (COFEPRIS) allows a public or private person to carry out activities related to human health.
Now that you know what a Sanitary Register is, it is very important that you know articles 179 and 180 of the Health Supplies Regulation (RIS) which describe the documentary requirements that must be submitted to COFEPRIS to obtain the Sanitary Register of the MD's.
The following is a description of the documents indicated in the two aforementioned articles for MD's of National and Foreign Manufacture.
Article 179. - National Manufacturing:
a) Application in Official Format.
I. The scientific and technical information to demonstrate that the health supplies meets the characteristics of safety and efficacy;
II. The Label project in Spanish language, under the terms of the corresponding Standard;
III. The instructions, if applicable, for its use or operation manual in Spanish language;
IV. The description of the manufacturing process that is carried out to obtain the product;
V. The description of the structure, materials, parts and functions, in the case of medical equipment;
VI. The certificate of good manufacturing practices;
VII. The laboratory tests to verify the specifications of the health supplies;
VIII. Bibliographic references; and
IX. Others established by the Secretariat in the corresponding Standards.
Article 180.- In addition to the above documents, the following must be included for Foreign Manufacturing:
I. The certificate of free sale or equivalent, issued by the sanitary authority of the country of origin;
II. The manufacturer's letter of representation, if the product is not manufactured by the parent company or factory or laboratory that requests the registration in Mexico;
III. The certificate of good manufacturing practices issued by the sanitary authority of the country of origin, and
IV. The original certificate of analysis issued by the company that manufactures the product, with the letterhead of its corporate name and signed by the responsible chemists of the foreign company.
It should be noted that the aforementioned documentary requirements must demonstrate the quality, safety and functionality of the MD´s, since this will dependo on this whether or not the Sanitary Register is granted and thus ensure their commercialization in the national territory.
Currently, the request for a new Sanitary Register can be made in two ways: in person (at the windows of the Integral Service Center of the COFEPRIS) and electronically (electronic procedures page of the COFEPRIS).
If you are about to request the Sanitary Register of a MD and you have doubts about any of the requirements mentioned above, contact us at the number 55 6167 7092, we can help you put together your dossier of MD Class I Low Risk, Class I, II and III with the support of our experience, quality and confidence in obtaining your Sanitary Register (Sanitary Authorizations).
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