Explore the medical device requirements currently available for Mexico, organized by topic and linked to official sources.
What expires, what is retained periodically, and when must renewal start?
Fixed Term
Initial registration is valid 5 years; the current first-extension service states a 10-year extension output, which should be retained as a route-specific current service rule.
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
File the applicable prórroga before expiry with current evidence.
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
Does the event require internal documentation, notice, prior approval, transfer, or a new application?
Administrative holder/distributor/importer changes and technical changes are separate services.
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?
Marketing Authorization Holder Or Registrant
Mexican registration holder
yes
Holds COFEPRIS Registration
May Be Holder Or Named Importer
May Be Holder Or Named Distributor
allowed
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
Administrative Modification Or Assignment Of Rights
Usually No For Valid Assignment
A holder transfer is an administrative change only if the facts fit the service; technical changes may need separate filing.
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
Which label and IFU elements, languages, symbols, and translation controls apply?
Spanish required; other languages may be additional
Spanish; translations/legalization as required
Verified Current
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
