The 101 about the dossier for medical devices’ Health Register in México

What is a Health Register?

The Health Register is a document with an alphanumeric code that certifies the authorization granted by the Ministry of Health through COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios) for the production, commercialization, and distribution of a health supplies.

Health supplies are classified into 6 different ones: (1) medical equipment , (2) prostheses, orthotics, and functional aids, (3) diagnostic agents, (4) dental supplies, (5) surgical and healing materials, and (6) hygienic products.

The Health Register is valid for five years with the possibility of extension. If the extension is not processed, it is canceled.

Which are the pathways to register a medical device?

There exist different pathways to register the medical devices depending on the class or origin of the device. It can be divided into three main categories:

(1) The standard review process: It is very straightforward. To obtain the Health Register through this process you have to make the dossier ensemble and its submission directly to COFEPRIS. This process takes between 10 to 12 months with a chance to be reduced depending on the device classification.

There are 4 classes depending on the risk level of the device: low risk, class I, class II, and class III, being this last one the riskiest one.

The class I devices, ideally by law, should have a response time of 30 business days , however, the reality is different. The process may take longer, mainly now during the coronavirus pandemic because COFEPRIS, together with the Health Secretary, has other priorities related to the COVID-19.

(2) Equivalency agreements: COFEPRIS accepts as equivalent the safety evaluation of devices previously registered in the USA, Canada, and Japan through FDA, Health Canada, and the Ministry of Health, Labour, and Welfare of Japan, respectively. Through this pathway, less technical information is required in the dossier because it has been previously approved by these trusted entities that endorse the security and performance of the device; however, apostilled and translated to Spanish documents are required, besides post-market surveillance information.

The waiting time to obtain the Health Register is another advantage since it is reduced up to 8 months.

(3) Authorized third-party reviewers: These are authorized companies by COFEPRIS that provide consultancy, review the documentation, and submit the dossier. Through these third-party reviewers is submitted as pre-approved and the response time is less, like two or three weeks approximately. However, since 2018 and the change in the political situation with the entrance of Andrés Manuel Lopez Obrador as president of Mexico, the administration of COFEPRIS has changed as well, and this pathway is not the most viable. The dossiers submitted by authorized third-party reviewers do not count as pre-approved anymore, so you will have to make a greater economical investment and with no time benefit, since it will be the same as the standard review process.

What is a dossier?

The dossier, also known as registration file, is the documental information that is presented to COFEPRIS to provide detailed and confidential information about the facilities, processes, supplies used in the manufacturing, and, together with the scientific evidence of quality, stability, efficacy, efficiency, and safety of the product, is requested for the authorization of a Health Register.

What information should I include in the dossier?

We can classify the required documents for the dossier ensemble into three: legal, technical, and in charge of the owner documents.

In the legal documentation we can include:

· Authorization letter of the manufacturer – letter in which the legal manufacturer provides the applicant the rights to commercialize, manufacture, sell, store and distribute its product.

· Certificate of free sell – document in which the health authority of the country of origin of the product satisfies the current legal provisions and is used freely and without restriction in that country.

· Good Manufacturing Practices Certificate – document that grants the manufacturing lines issued by the health regulations of the country of origin.

· Approval of FDA, Health Canada, or the Ministry of Health, Labour and Welfare of Japan, when applicable.

Within the technical documentation we can find:

· General information about the product – it can be through a monography or a set of documents that describes the performance, denomination, intended use, description of the quali-quantitative formula, components, and other general aspects of the device.

· Instructions – contains information about the operation, maintenance, and cleaning of the product, when applicable. The conditions of conservation, storage, warnings, contraindications, and other information that is considered pertinent are also included.

· Labeling information – presented through the device label or label project. You need to mention all the information that the device will have once it goes on sale. The labeling must follow the applicable standards, such as NOM-137-SSA1-2008. A back label can be added in case the product origin information is not complete.

· Description of the manufacturing process – includes the process of each of the establishments involved, the description of the manufacturing process of each of the parts, and finally the description of the assembly to obtain the final product.

· Laboratory tests – according to international standards. It is possible to provide a clarifying letter that the tests were carried out on a similar device, presenting a comparison report of both devices and that the technology is equivalent.

· Biocompatibility tests – it is demonstrated that the device does not cause toxicity, irritation, or skin sensitization regarding the FEUM (Farmacopea de los Estados Unidos Mexicanos), other pharmacopeias, or international standards such as ISO 10993.

· Stability tests – for those devices that have an expiration date and guarantee the expiration of the product or product packaging. Delayed aging tests can be submitted.

· Clinical studies – research that supports the use, operation, and safety of the product in people. Clinical studies of similar devices can be presented with the corresponding justification.

· Sterilization information – includes information about the sterilization process and certificate of sterility.

· Packaging information – description and materials of primary, secondary, and tertiary packaging.

· Certificate of Analysis (CoA) – also known as the certificate of quality or conformity. It certifies that the finished product passes the final physical and functional tests as a finished product before being taken for sale.

Within the documents in charge of the owner are included:

· Authorizations, Certificates, and Visits Format

· Proof of payment

· Declaration of the sanitary responsible - letter that declares that the documents are valid, true, current, correct, and provided by the manufacturer.

· Explanatory letters, as many as necessary

· Notice of operation and health responsible - notice of operation of manufacturing and commercialization of all distributors to be included in the sanitary registry must be delivered.

We can help you!

If after this 101 in assembling the dossier to obtain Health Registry you still have doubts, write us and we will gladly provide you with technical and regulatory advice. Since the assembly and review, to the submission and monitoring of the dossier with COFEPRIS.