Mexico medical device regulations

The July 2025 agreement merges administrative changes and device registration-rights assignment into COFEPRIS-2022-022-003 immediateA/adjudicatedB. May 2026 ArtV requires FF-COFEPRIS-15 or the digital form, fee proof and the document for the actual modification under the incorporated classification criteria. ArtIX prohibits demanding COFEPRIS-issued documents, simple-copy duplicates or additional requirements beyond that agreement; legal-representation evidence applies as stated. Older guide copy/duplicate instructions must be read with these later rules.

The current003 service lists B3 for a device trade-name or catalogue-number change. The guide requires the manufacturer’s justified change statement and no technical change to the authorized sanitary conditions; use the current form and type-specific evidence. Its note says the catalogue/reference/model/code number may not be eliminated through this catalogue-change route. The separately incorporated criteria also list presentation elimination/reference-code changes, so distinguish the actual requested change rather than treating all REF operations identically.

LFD195-A sets2026 device registration bases at MXN16,498.70 for class I,24,198.08 for class II and30,797.57 for class III. Its express modification paragraphs charge50% for holder business-name/other holder changes and75% for other modifications. The guide specifies50% for assignment,75% when importer/distributor is also modified. Apply the actual statutory trigger and class; a manufacturer name or brand change is not automatically the holder’s50% case.

The current003 service publishes15 working days. May 2026 ArtVI item19 reduces adjudicated administrative changes from 22 to15 working days, but transitory5 makes reduced times operative once the necessary technological tools/platforms are functioning. Apply the 15-working-day service to the actual accepted adjudicated administrative route; immediateA has a separately published interim10-working-day in-person arrangement while platforms are adapted. This does not establish a common clock for mixed administrative/technical or multi-registration filings.

LFPA17-A permits one written information request, gives the applicant at least five working days to respond, and suspends the resolution period from timely notification until the working day after the response. In the absence of a specific period, the request is due in the first third of the applicable response period. These are deficiency rules, not an extra universal fixed duration.

NOM 137-SSA1-2008 requires the applicable distinctive/generic device name, manufacturer/importer/distributor role names and addresses, origin, registration and lot/serial details in the required Spanish label/counter-label. Section8 checks the authorized updated label against the registration. A change in registered brand or legal party therefore needs corresponding label consistency; do not confuse a catalogue code with an automatically assigned UDI-DI.

RIS189 requires the modification authorization to state the time allowed to exhaust packaging materials and finished stock; the authority’s period cannot exceed240 working days. It is a ceiling, not an automatic240-working-day right for every change. Obtain the actual decision and follow its product/stock conditions before using old labels.

B1 covers the holder, distributor, importer or actual/legal manufacturer’s business-name change excluding assignment. Provide the applicable official/legal or manufacturer name-change proof and representation evidence for the domestic/foreign role, authenticated and translated as specified. The guide permits one original to be referenced in separate name-change applications; it does not turn several registrations into one application. Read its copy requirements subject to the later simplification agreement.

LFD195-A sets2026 device registration bases at MXN16,498.70 for class I,24,198.08 for class II and30,797.57 for class III. Its express modification paragraphs charge50% for holder business-name/other holder changes and75% for other modifications. The guide specifies50% for assignment,75% when importer/distributor is also modified. Apply the actual statutory trigger and class; a manufacturer name or brand change is not automatically the holder’s50% case.

The current003 service publishes15 working days. May 2026 ArtVI item19 reduces adjudicated administrative changes from 22 to15 working days, but transitory5 makes reduced times operative once the necessary technological tools/platforms are functioning. Apply the 15-working-day service to the actual accepted adjudicated administrative route; immediateA has a separately published interim10-working-day in-person arrangement while platforms are adapted. This does not establish a common clock for mixed administrative/technical or multi-registration filings.

LFPA17-A permits one written information request, gives the applicant at least five working days to respond, and suspends the resolution period from timely notification until the working day after the response. In the absence of a specific period, the request is due in the first third of the applicable response period. These are deficiency rules, not an extra universal fixed duration.

NOM 137-SSA1-2008 requires the applicable distinctive/generic device name, manufacturer/importer/distributor role names and addresses, origin, registration and lot/serial details in the required Spanish label/counter-label. Section8 checks the authorized updated label against the registration. A change in registered brand or legal party therefore needs corresponding label consistency; do not confuse a catalogue code with an automatically assigned UDI-DI.

RIS189 requires the modification authorization to state the time allowed to exhaust packaging materials and finished stock; the authority’s period cannot exceed240 working days. It is a ceiling, not an automatic240-working-day right for every change. Obtain the actual decision and follow its product/stock conditions before using old labels.

B5 covers a changed expression of the actual/legal manufacturer’s site address only where the physical place is unchanged and no manufacturing-site change occurs. Provide the manufacturer’s justified statement; official postal/government reassignment evidence applies where that explains the change. A move to a different office address is not proved to fall within this same-place exception, even when the factory stays put; identify which legal/actual-manufacturer field and establishment changes.

LFD195-A sets2026 device registration bases at MXN16,498.70 for class I,24,198.08 for class II and30,797.57 for class III. Its express modification paragraphs charge50% for holder business-name/other holder changes and75% for other modifications. The guide specifies50% for assignment,75% when importer/distributor is also modified. Apply the actual statutory trigger and class; a manufacturer name or brand change is not automatically the holder’s50% case.

The current003 service publishes15 working days. May 2026 ArtVI item19 reduces adjudicated administrative changes from 22 to15 working days, but transitory5 makes reduced times operative once the necessary technological tools/platforms are functioning. Apply the 15-working-day service to the actual accepted adjudicated administrative route; immediateA has a separately published interim10-working-day in-person arrangement while platforms are adapted. This does not establish a common clock for mixed administrative/technical or multi-registration filings.

LFPA17-A permits one written information request, gives the applicant at least five working days to respond, and suspends the resolution period from timely notification until the working day after the response. In the absence of a specific period, the request is due in the first third of the applicable response period. These are deficiency rules, not an extra universal fixed duration.

NOM 137-SSA1-2008 requires the applicable distinctive/generic device name, manufacturer/importer/distributor role names and addresses, origin, registration and lot/serial details in the required Spanish label/counter-label. Section8 checks the authorized updated label against the registration. A change in registered brand or legal party therefore needs corresponding label consistency; do not confuse a catalogue code with an automatically assigned UDI-DI.

RIS189 requires the modification authorization to state the time allowed to exhaust packaging materials and finished stock; the authority’s period cannot exceed240 working days. It is a ceiling, not an automatic240-working-day right for every change. Obtain the actual decision and follow its product/stock conditions before using old labels.

The July 2025 agreement merges administrative changes and device registration-rights assignment into COFEPRIS-2022-022-003 immediateA/adjudicatedB. May 2026 ArtV requires FF-COFEPRIS-15 or the digital form, fee proof and the document for the actual modification under the incorporated classification criteria. ArtIX prohibits demanding COFEPRIS-issued documents, simple-copy duplicates or additional requirements beyond that agreement; legal-representation evidence applies as stated. Older guide copy/duplicate instructions must be read with these later rules.

The current003 service lists B3 for a device trade-name or catalogue-number change. The guide requires the manufacturer’s justified change statement and no technical change to the authorized sanitary conditions; use the current form and type-specific evidence. Its note says the catalogue/reference/model/code number may not be eliminated through this catalogue-change route. The separately incorporated criteria also list presentation elimination/reference-code changes, so distinguish the actual requested change rather than treating all REF operations identically.

LFD195-A sets2026 device registration bases at MXN16,498.70 for class I,24,198.08 for class II and30,797.57 for class III. Its express modification paragraphs charge50% for holder business-name/other holder changes and75% for other modifications. The guide specifies50% for assignment,75% when importer/distributor is also modified. Apply the actual statutory trigger and class; a manufacturer name or brand change is not automatically the holder’s50% case.

The current003 service publishes15 working days. May 2026 ArtVI item19 reduces adjudicated administrative changes from 22 to15 working days, but transitory5 makes reduced times operative once the necessary technological tools/platforms are functioning. Apply the 15-working-day service to the actual accepted adjudicated administrative route; immediateA has a separately published interim10-working-day in-person arrangement while platforms are adapted. This does not establish a common clock for mixed administrative/technical or multi-registration filings.

LFPA17-A permits one written information request, gives the applicant at least five working days to respond, and suspends the resolution period from timely notification until the working day after the response. In the absence of a specific period, the request is due in the first third of the applicable response period. These are deficiency rules, not an extra universal fixed duration.

NOM 137-SSA1-2008 requires the applicable distinctive/generic device name, manufacturer/importer/distributor role names and addresses, origin, registration and lot/serial details in the required Spanish label/counter-label. Section8 checks the authorized updated label against the registration. A change in registered brand or legal party therefore needs corresponding label consistency; do not confuse a catalogue code with an automatically assigned UDI-DI.

RIS189 requires the modification authorization to state the time allowed to exhaust packaging materials and finished stock; the authority’s period cannot exceed240 working days. It is a ceiling, not an automatic240-working-day right for every change. Obtain the actual decision and follow its product/stock conditions before using old labels.

B2 is change/addition of the legal manufacturer responsible for device quality. Supply the legal document justifying the change, authenticated/translated as stated for foreign manufacture, and the applicable representation letter. The guide allows the stated CFS or legal relationship document and limits this route to unchanged sanitary conditions that could affect quality, safety or effectiveness. It is not a simple B1 same-person rename and does not itself assign the Mexican registration to a new holder.

The new holder must notify assignment within 30 working days after it occurs. The guide requires a deed identifying the transferred registrations signed by assignor and assignee, matching the current holder and a valid registration or pending renewal, plus the applicable new-holder label and representation evidence. The current administrative service includes assignment under adjudication; later simplification removes superseded duplicate/copy requirements. A foreign manufacturer succession and a Mexican holder assignment must be mapped separately.

LFD195-A sets2026 device registration bases at MXN16,498.70 for class I,24,198.08 for class II and30,797.57 for class III. Its express modification paragraphs charge50% for holder business-name/other holder changes and75% for other modifications. The guide specifies50% for assignment,75% when importer/distributor is also modified. Apply the actual statutory trigger and class; a manufacturer name or brand change is not automatically the holder’s50% case.

The current003 service publishes15 working days. May 2026 ArtVI item19 reduces adjudicated administrative changes from 22 to15 working days, but transitory5 makes reduced times operative once the necessary technological tools/platforms are functioning. Apply the 15-working-day service to the actual accepted adjudicated administrative route; immediateA has a separately published interim10-working-day in-person arrangement while platforms are adapted. This does not establish a common clock for mixed administrative/technical or multi-registration filings.

LFPA17-A permits one written information request, gives the applicant at least five working days to respond, and suspends the resolution period from timely notification until the working day after the response. In the absence of a specific period, the request is due in the first third of the applicable response period. These are deficiency rules, not an extra universal fixed duration.

NOM 137-SSA1-2008 requires the applicable distinctive/generic device name, manufacturer/importer/distributor role names and addresses, origin, registration and lot/serial details in the required Spanish label/counter-label. Section8 checks the authorized updated label against the registration. A change in registered brand or legal party therefore needs corresponding label consistency; do not confuse a catalogue code with an automatically assigned UDI-DI.

RIS189 requires the modification authorization to state the time allowed to exhaust packaging materials and finished stock; the authority’s period cannot exceed240 working days. It is a ceiling, not an automatic240-working-day right for every change. Obtain the actual decision and follow its product/stock conditions before using old labels.

The guide treats CFS, legal manufacturer relationship/representation documents and GMP evidence as different documents. In B2 it permits the stated CFS or legal relationship document; actual manufacturing-site/technical branches have their own supporting evidence. The 20March2025 formal lineamientos Art. 15 recognizes the stated MDSAP, reference-authority GMP, current accredited ISO13485, CE and official-CFS explicit-GMP alternatives for devices. Authentication, electronic verification and validity rules still apply. This does not require a new CFS for every logo or internal REF change.

B1 covers the holder, distributor, importer or actual/legal manufacturer’s business-name change excluding assignment. Provide the applicable official/legal or manufacturer name-change proof and representation evidence for the domestic/foreign role, authenticated and translated as specified. The guide permits one original to be referenced in separate name-change applications; it does not turn several registrations into one application. Read its copy requirements subject to the later simplification agreement.

B5 covers a changed expression of the actual/legal manufacturer’s site address only where the physical place is unchanged and no manufacturing-site change occurs. Provide the manufacturer’s justified statement; official postal/government reassignment evidence applies where that explains the change. A move to a different office address is not proved to fall within this same-place exception, even when the factory stays put; identify which legal/actual-manufacturer field and establishment changes.

The current003 service lists B3 for a device trade-name or catalogue-number change. The guide requires the manufacturer’s justified change statement and no technical change to the authorized sanitary conditions; use the current form and type-specific evidence. Its note says the catalogue/reference/model/code number may not be eliminated through this catalogue-change route. The separately incorporated criteria also list presentation elimination/reference-code changes, so distinguish the actual requested change rather than treating all REF operations identically.

B2 is change/addition of the legal manufacturer responsible for device quality. Supply the legal document justifying the change, authenticated/translated as stated for foreign manufacture, and the applicable representation letter. The guide allows the stated CFS or legal relationship document and limits this route to unchanged sanitary conditions that could affect quality, safety or effectiveness. It is not a simple B1 same-person rename and does not itself assign the Mexican registration to a new holder.

The new holder must notify assignment within 30 working days after it occurs. The guide requires a deed identifying the transferred registrations signed by assignor and assignee, matching the current holder and a valid registration or pending renewal, plus the applicable new-holder label and representation evidence. The current administrative service includes assignment under adjudication; later simplification removes superseded duplicate/copy requirements. A foreign manufacturer succession and a Mexican holder assignment must be mapped separately.

LFD195-A sets2026 device registration bases at MXN16,498.70 for class I,24,198.08 for class II and30,797.57 for class III. Its express modification paragraphs charge50% for holder business-name/other holder changes and75% for other modifications. The guide specifies50% for assignment,75% when importer/distributor is also modified. Apply the actual statutory trigger and class; a manufacturer name or brand change is not automatically the holder’s50% case.

The current003 service publishes15 working days. May 2026 ArtVI item19 reduces adjudicated administrative changes from 22 to15 working days, but transitory5 makes reduced times operative once the necessary technological tools/platforms are functioning. Apply the 15-working-day service to the actual accepted adjudicated administrative route; immediateA has a separately published interim10-working-day in-person arrangement while platforms are adapted. This does not establish a common clock for mixed administrative/technical or multi-registration filings.

LFPA17-A permits one written information request, gives the applicant at least five working days to respond, and suspends the resolution period from timely notification until the working day after the response. In the absence of a specific period, the request is due in the first third of the applicable response period. These are deficiency rules, not an extra universal fixed duration.

NOM 137-SSA1-2008 requires the applicable distinctive/generic device name, manufacturer/importer/distributor role names and addresses, origin, registration and lot/serial details in the required Spanish label/counter-label. Section8 checks the authorized updated label against the registration. A change in registered brand or legal party therefore needs corresponding label consistency; do not confuse a catalogue code with an automatically assigned UDI-DI.

RIS189 requires the modification authorization to state the time allowed to exhaust packaging materials and finished stock; the authority’s period cannot exceed240 working days. It is a ceiling, not an automatic240-working-day right for every change. Obtain the actual decision and follow its product/stock conditions before using old labels.

The guide treats CFS, legal manufacturer relationship/representation documents and GMP evidence as different documents. In B2 it permits the stated CFS or legal relationship document; actual manufacturing-site/technical branches have their own supporting evidence. The 20March2025 formal lineamientos Art. 15 recognizes the stated MDSAP, reference-authority GMP, current accredited ISO13485, CE and official-CFS explicit-GMP alternatives for devices. Authentication, electronic verification and validity rules still apply. This does not require a new CFS for every logo or internal REF change.