Consulting and compiling different regulatory submissions for health products and services. We handle three types of submissions:
Equivalence Agreement Path, when regardless of the country of manufacture, the medical device is commercialized either in the United States or Canada and has specific regulatory documentation from FDA or Health Canada.
Traditional Path, when the product is not approved by FDA or Health Canada and has a Free Sale Certificate from the country of manufacture.
Use of a Third Party, when the product needs to be registered in a short period of time and the device needs to be filed by Traditional Path, the legal figure of a Third Party that issues a report accompanying the medical device dossier to the Authority to facilitate and fasten the revision process of the Sanitary Authority can be chosen.
For companies located outside Mexico, one of the most important services we provide is the possibility of being Holder of Health Registrations. This means that the owner of the registration is not a distributor but an independent consultant legal entity. Having the registration with RHS as Holder allows manufacturers to add or remove distributors at any time.
Health SubmissionsWe are the consulting option that provides different regulatory options for you to choose the one that suits best the registration needs of your product
Health Registration Holder
Medical Device according to Rule 83 from R.I.S
Technical and Administrative Amendments to Health Registrations
Renewal for Health Registrations
Adverse Events Reports
Response to Preventions/Deficiency Letters
Operations Notification and Responsible Party Notification
Follow-up to COFEPRIS Audits
Creation of Standard Operating Procedures
The time that takes to complete a dossier depends on how complete the file is received. An average dossier takes more than two months to be completed including the time it takes to translation the documents into Spanish.
The time required for translation depends on the number of pages that make up a dossier.
For the registration to be issued by the Authority, COFEPRIS requires the payment of Rights prior to filing the dossier.
Registrations are valid for 5 years with the possibility of renewing by periods of 5 years. The submission of the renewal needs to begin one year before the expiration date.
Changes made to the device, such as adding new manufacturing sites, new shelf life timing, or adding new catalog numbers requires a technical amendment to the existing Registration.
Some implantable medical devices, in addition to the Health Registration, require a Sanitary Import Permit to clear customs.