Brazil medical device regulations

Changes to notification or registration are approval-required, immediate, or non-reportable. Classes I/II use immediate implementation except non-reportable changes. Minor non-technical images, layout, symbols or text without added risk, and contact/postal-address updates, can be non-reportable when they do not change the design; control them in the holder’s quality system and incorporate them into later petitions. A trade-name change is not automatically a logo-artwork exemption.

RDC 857 Annex I7.9.1 sets product-registration alteration/inclusion factor 738 DV2 at BRL3514.32,2987.17,2460.02,1405.73,351.43 or175.72 by company-size column. The separate label/IFU alteration item7.9.2 factor 742 DV0 is exempt. Map the actual petition subject to its factor; a commercial-name or manufacturer change is not automatically a label-only exempt petition.

RDC 743’s Annex lists 30 days for the enumerated immediate device/IVD alteration subjects and 150 days for approval-required subjects; the latter rows exclude tacit approval. These are printed as days, not expressly working days. MD Art. 22 as replaced by RDC 777, and IVD RDC 830 Art. 22, provide publication independently of documentary review without printing the old 30-day publication phrase. Do not treat the table as a guaranteed pre-implementation wait or as approval for any combined transfer.

Under Decree 10178 Arts. 10–15, the approval period starts when all necessary instruction elements are submitted; the authority must state the deadline. A documentary-complement request can suspend the clock, with the stated new-fact exception. These provisions do not create a universal 60-day or 90-day device alteration period.

RDC 591 Annex II2.9 as amended by RDC 884 requires a new UDI-DI where a change could create identification ambiguity, and expressly for trade/commercial-model name changes. Under2.12 a label change solely to add UDI is not itself a regularization-change petition. A customer’s internal REF is not automatically a commercial model or UDI-DI; establish what registered and issued identifiers actually change.

File the applicable petition subject, the fee or exemption where applicable, a declaration listing the requested alterations, and documentary evidence supporting them. A single label mock-up does not replace the subject-specific technical dossier or manufacturer evidence.

Registered IVD commercial-name change subject 8007 requires updated primary/secondary label images, updated IFU/manual, a digitally signed technical-responsible declaration listing the changes, and affected portions of the technical dossier.

For subject 80198, submit primary/secondary labels and an updated IFU highlighting changes, or justified no-impact documents, plus the technical-responsible signed change declaration. Affected technical-dossier portions are required by this list for class II. A change of notification holder is governed separately by the new-notification rule.

For an ordinary alteration, old and new finished-device versions may be imported and sold until expiry or the end of useful life. Unused packaging, labels and IFUs may be exhausted for 120 days from publication of the alteration. Changes made to resolve safety or performance problems are excluded from both permissions. The publication trigger does not create an implementation-date clock for an unpublished non-reportable artwork change.

Changes to notification or registration are approval-required, immediate, or non-reportable. Classes I/II use immediate implementation except non-reportable changes. Minor non-technical images, layout, symbols or text without added risk, and contact/postal-address updates, can be non-reportable when they do not change the design; control them in the holder’s quality system and incorporate them into later petitions. A trade-name change is not automatically a logo-artwork exemption.

RDC 857 Annex I7.9.1 sets product-registration alteration/inclusion factor 738 DV2 at BRL3514.32,2987.17,2460.02,1405.73,351.43 or175.72 by company-size column. The separate label/IFU alteration item7.9.2 factor 742 DV0 is exempt. Map the actual petition subject to its factor; a commercial-name or manufacturer change is not automatically a label-only exempt petition.

RDC 743’s Annex lists 30 days for the enumerated immediate device/IVD alteration subjects and 150 days for approval-required subjects; the latter rows exclude tacit approval. These are printed as days, not expressly working days. MD Art. 22 as replaced by RDC 777, and IVD RDC 830 Art. 22, provide publication independently of documentary review without printing the old 30-day publication phrase. Do not treat the table as a guaranteed pre-implementation wait or as approval for any combined transfer.

Under Decree 10178 Arts. 10–15, the approval period starts when all necessary instruction elements are submitted; the authority must state the deadline. A documentary-complement request can suspend the clock, with the stated new-fact exception. These provisions do not create a universal 60-day or 90-day device alteration period.

RDC 591 Annex II2.9 as amended by RDC 884 requires a new UDI-DI where a change could create identification ambiguity, and expressly for trade/commercial-model name changes. Under2.12 a label change solely to add UDI is not itself a regularization-change petition. A customer’s internal REF is not automatically a commercial model or UDI-DI; establish what registered and issued identifiers actually change.

The official registered-device alteration FAQ says that a petition permits only its requested alteration item and other inserted alterations are disregarded. This must be read with the legal rule requiring an interdependent immediate change to accompany the approval-required change. It does not authorize combining every name/address/REF/holder change into one fee or decision.

File the applicable petition subject, the fee or exemption where applicable, a declaration listing the requested alterations, and documentary evidence supporting them. A single label mock-up does not replace the subject-specific technical dossier or manufacturer evidence.

Subject8020 is exclusively a foreign legal-manufacturer or manufacturing-unit corporate-name change. Supply label/IFU updates or justified no-impact statements, the manufacturer’s reason document, the imported legal-manufacturer authorization where its name changes, the updated Anvisa GMP certificate or protocol where the plant name changes, and affected dossier sections. Address/process changes use their pertinent subjects; corporate purchase, sale, merger or division is a manufacturer/site change, not this name-only subject.

For subject 80198, submit primary/secondary labels and an updated IFU highlighting changes, or justified no-impact documents, plus the technical-responsible signed change declaration. Affected technical-dossier portions are required by this list for class II. A change of notification holder is governed separately by the new-notification rule.

For an ordinary alteration, old and new finished-device versions may be imported and sold until expiry or the end of useful life. Unused packaging, labels and IFUs may be exhausted for 120 days from publication of the alteration. Changes made to resolve safety or performance problems are excluded from both permissions. The publication trigger does not create an implementation-date clock for an unpublished non-reportable artwork change.

An immediate alteration that is interdependent with an approval-required alteration must be filed jointly with it and incorporated into that petition. Approval-required changes take effect only after the final decision is published in the Diário Oficial da União.

Changes to notification or registration are approval-required, immediate, or non-reportable. Classes I/II use immediate implementation except non-reportable changes. Minor non-technical images, layout, symbols or text without added risk, and contact/postal-address updates, can be non-reportable when they do not change the design; control them in the holder’s quality system and incorporate them into later petitions. A trade-name change is not automatically a logo-artwork exemption.

RDC 857 Annex I7.9.1 sets product-registration alteration/inclusion factor 738 DV2 at BRL3514.32,2987.17,2460.02,1405.73,351.43 or175.72 by company-size column. The separate label/IFU alteration item7.9.2 factor 742 DV0 is exempt. Map the actual petition subject to its factor; a commercial-name or manufacturer change is not automatically a label-only exempt petition.

RDC 743’s Annex lists 30 days for the enumerated immediate device/IVD alteration subjects and 150 days for approval-required subjects; the latter rows exclude tacit approval. These are printed as days, not expressly working days. MD Art. 22 as replaced by RDC 777, and IVD RDC 830 Art. 22, provide publication independently of documentary review without printing the old 30-day publication phrase. Do not treat the table as a guaranteed pre-implementation wait or as approval for any combined transfer.

Under Decree 10178 Arts. 10–15, the approval period starts when all necessary instruction elements are submitted; the authority must state the deadline. A documentary-complement request can suspend the clock, with the stated new-fact exception. These provisions do not create a universal 60-day or 90-day device alteration period.

RDC 591 Annex II2.9 as amended by RDC 884 requires a new UDI-DI where a change could create identification ambiguity, and expressly for trade/commercial-model name changes. Under2.12 a label change solely to add UDI is not itself a regularization-change petition. A customer’s internal REF is not automatically a commercial model or UDI-DI; establish what registered and issued identifiers actually change.

The official registered-device alteration FAQ says that a petition permits only its requested alteration item and other inserted alterations are disregarded. This must be read with the legal rule requiring an interdependent immediate change to accompany the approval-required change. It does not authorize combining every name/address/REF/holder change into one fee or decision.

File the applicable petition subject, the fee or exemption where applicable, a declaration listing the requested alterations, and documentary evidence supporting them. A single label mock-up does not replace the subject-specific technical dossier or manufacturer evidence.

Subject8020 is exclusively a foreign legal-manufacturer or manufacturing-unit corporate-name change. Supply label/IFU updates or justified no-impact statements, the manufacturer’s reason document, the imported legal-manufacturer authorization where its name changes, the updated Anvisa GMP certificate or protocol where the plant name changes, and affected dossier sections. Address/process changes use their pertinent subjects; corporate purchase, sale, merger or division is a manufacturer/site change, not this name-only subject.

For subject 80198, submit primary/secondary labels and an updated IFU highlighting changes, or justified no-impact documents, plus the technical-responsible signed change declaration. Affected technical-dossier portions are required by this list for class II. A change of notification holder is governed separately by the new-notification rule.

For an ordinary alteration, old and new finished-device versions may be imported and sold until expiry or the end of useful life. Unused packaging, labels and IFUs may be exhausted for 120 days from publication of the alteration. Changes made to resolve safety or performance problems are excluded from both permissions. The publication trigger does not create an implementation-date clock for an unpublished non-reportable artwork change.

An immediate alteration that is interdependent with an approval-required alteration must be filed jointly with it and incorporated into that petition. Approval-required changes take effect only after the final decision is published in the Diário Oficial da União.

Changes to notification or registration are approval-required, immediate, or non-reportable. Classes I/II use immediate implementation except non-reportable changes. Minor non-technical images, layout, symbols or text without added risk, and contact/postal-address updates, can be non-reportable when they do not change the design; control them in the holder’s quality system and incorporate them into later petitions. A trade-name change is not automatically a logo-artwork exemption.

RDC 857 Annex I7.9.1 sets product-registration alteration/inclusion factor 738 DV2 at BRL3514.32,2987.17,2460.02,1405.73,351.43 or175.72 by company-size column. The separate label/IFU alteration item7.9.2 factor 742 DV0 is exempt. Map the actual petition subject to its factor; a commercial-name or manufacturer change is not automatically a label-only exempt petition.

RDC 743’s Annex lists 30 days for the enumerated immediate device/IVD alteration subjects and 150 days for approval-required subjects; the latter rows exclude tacit approval. These are printed as days, not expressly working days. MD Art. 22 as replaced by RDC 777, and IVD RDC 830 Art. 22, provide publication independently of documentary review without printing the old 30-day publication phrase. Do not treat the table as a guaranteed pre-implementation wait or as approval for any combined transfer.

Under Decree 10178 Arts. 10–15, the approval period starts when all necessary instruction elements are submitted; the authority must state the deadline. A documentary-complement request can suspend the clock, with the stated new-fact exception. These provisions do not create a universal 60-day or 90-day device alteration period.

RDC 591 Annex II2.9 as amended by RDC 884 requires a new UDI-DI where a change could create identification ambiguity, and expressly for trade/commercial-model name changes. Under2.12 a label change solely to add UDI is not itself a regularization-change petition. A customer’s internal REF is not automatically a commercial model or UDI-DI; establish what registered and issued identifiers actually change.

The official registered-device alteration FAQ says that a petition permits only its requested alteration item and other inserted alterations are disregarded. This must be read with the legal rule requiring an interdependent immediate change to accompany the approval-required change. It does not authorize combining every name/address/REF/holder change into one fee or decision.

File the applicable petition subject, the fee or exemption where applicable, a declaration listing the requested alterations, and documentary evidence supporting them. A single label mock-up does not replace the subject-specific technical dossier or manufacturer evidence.

For subject 80198, submit primary/secondary labels and an updated IFU highlighting changes, or justified no-impact documents, plus the technical-responsible signed change declaration. Affected technical-dossier portions are required by this list for class II. A change of notification holder is governed separately by the new-notification rule.

For an ordinary alteration, old and new finished-device versions may be imported and sold until expiry or the end of useful life. Unused packaging, labels and IFUs may be exhausted for 120 days from publication of the alteration. Changes made to resolve safety or performance problems are excluded from both permissions. The publication trigger does not create an implementation-date clock for an unpublished non-reportable artwork change.

An immediate alteration that is interdependent with an approval-required alteration must be filed jointly with it and incorporated into that petition. Approval-required changes take effect only after the final decision is published in the Diário Oficial da União.

IN 74 Annex II lists commercial-name changes and foreign legal-manufacturer or factory corporate-name changes as immediate subjects. For equipment and materials it also expressly lists commercial-model name/code changes. The IVD rows separately list commercial name, commercial presentation and legal manufacturer without a manufacturing-process change; the equipment model/code wording must not be applied automatically to an IVD orderable REF.

Transfer requires the signed petition form, GRU proof of TFVS payment/exemption, Annex I transaction declaration and updated operating/sanitary licence. Pending initial applications are updated by an amendment rather than a transfer of an issued registration. Pending post-registration petitions transfer only when declared in Annex I; unlisted petitions are closed. Holder-only label/IFU updates may be implemented after transfer approval.

RDC 903 Arts. 7–14 require the applicable company-authorization and GMP/distribution-certificate updates following corporate/commercial operations. A new legal person or unregularized successor needs initial AFE/AE as applicable. For a qualifying unchanged production line, CBPF update preserves certificate validity; an exclusively foreign operation is petitioned by the current certification applicant. Art. 13 lists the form, existing certificate, transaction declaration, applicable updated AFE publication, and successor-country GMP certificate or competent-authority transaction attestation for a foreign operation.

RDC 857 Art. 10 conditions holder transfer on any positive TFVS difference associated with the successor’s economic size and provides no refund if it is smaller. Simultaneous renewal and later transfer use the specified size-reference dates; a later transfer also triggers the alteration charge. Calculate the actual petition and size difference rather than assuming an ordinary label-only exemption.

The successor is responsible for remaining finished stock. Finished stock produced before the individual transfer/cancellation resolutions take effect may be imported or sold for at most180 days after that effective date. Outdated packaging cannot be used for new lots produced afterwards. Unless otherwise stated, those individual resolutions take effect90 days after publication. These180/90-day periods are stock/effect rules, not agency review periods.

IN 426 Art. 8 requires completion of the formal RDC 903 holder transfer before SIUD data transfer; successor data are transmitted for the new registration numbers within 30 days after the individual transfer/cancellation resolutions take effect. Art. 7§3 separately gives30 calendar days from publication for replacement where the change requires a new UDI-DI. These data deadlines are not agency variation-review periods.

The official registered-device alteration FAQ says that a petition permits only its requested alteration item and other inserted alterations are disregarded. This must be read with the legal rule requiring an interdependent immediate change to accompany the approval-required change. It does not authorize combining every name/address/REF/holder change into one fee or decision.

IVD transfer subject 80074 (product) and80078 (family) require the RDC 903 Annex I declaration digitally signed by legal and technical responsibles, the updated operating/sanitary licence and an Anvisa GMP certificate in the successor’s name or its application protocol. Parent RDC 903 Art. 30 also requires the petition form and TFVS payment/exemption. The family subject is not proof that an arbitrary collection of products qualifies as a family.

Subject8011 requires updated labels and IFU, a technical-responsible signed change declaration identifying the manufacturer, the apostilled/consularized imported-manufacturer authorization and GMP undertaking, and affected dossier sections. Multiple legal manufacturers need same-group proof. If the legal manufacturer is itself the factory, include the updated Anvisa GMP certificate or protocol and also file the approval-required manufacturing-site alteration.

An immediate alteration that is interdependent with an approval-required alteration must be filed jointly with it and incorporated into that petition. Approval-required changes take effect only after the final decision is published in the Diário Oficial da União.

For an unchanged registered product, the successor’s holder-transfer petition and predecessor’s cancellation petition must be filed concurrently within 180 days of the registered corporate act or asset-transfer contract, subject to the separate Mercosur trigger. Late petitions are refused. Products subject to notification or exemption are not transferred: the successor makes a new notification or regularization. A simple same-person corporate-name change is excluded from this transaction regime.

Changes to notification or registration are approval-required, immediate, or non-reportable. Classes I/II use immediate implementation except non-reportable changes. Minor non-technical images, layout, symbols or text without added risk, and contact/postal-address updates, can be non-reportable when they do not change the design; control them in the holder’s quality system and incorporate them into later petitions. A trade-name change is not automatically a logo-artwork exemption.

An immediate alteration that is interdependent with an approval-required alteration must be filed jointly with it and incorporated into that petition. Approval-required changes take effect only after the final decision is published in the Diário Oficial da União.

Transfer requires the signed petition form, GRU proof of TFVS payment/exemption, Annex I transaction declaration and updated operating/sanitary licence. Pending initial applications are updated by an amendment rather than a transfer of an issued registration. Pending post-registration petitions transfer only when declared in Annex I; unlisted petitions are closed. Holder-only label/IFU updates may be implemented after transfer approval.

RDC 903 Arts. 7–14 require the applicable company-authorization and GMP/distribution-certificate updates following corporate/commercial operations. A new legal person or unregularized successor needs initial AFE/AE as applicable. For a qualifying unchanged production line, CBPF update preserves certificate validity; an exclusively foreign operation is petitioned by the current certification applicant. Art. 13 lists the form, existing certificate, transaction declaration, applicable updated AFE publication, and successor-country GMP certificate or competent-authority transaction attestation for a foreign operation.

RDC 857 Annex I7.9.1 sets product-registration alteration/inclusion factor 738 DV2 at BRL3514.32,2987.17,2460.02,1405.73,351.43 or175.72 by company-size column. The separate label/IFU alteration item7.9.2 factor 742 DV0 is exempt. Map the actual petition subject to its factor; a commercial-name or manufacturer change is not automatically a label-only exempt petition.

RDC 857 Art. 10 conditions holder transfer on any positive TFVS difference associated with the successor’s economic size and provides no refund if it is smaller. Simultaneous renewal and later transfer use the specified size-reference dates; a later transfer also triggers the alteration charge. Calculate the actual petition and size difference rather than assuming an ordinary label-only exemption.

RDC 743’s Annex lists 30 days for the enumerated immediate device/IVD alteration subjects and 150 days for approval-required subjects; the latter rows exclude tacit approval. These are printed as days, not expressly working days. MD Art. 22 as replaced by RDC 777, and IVD RDC 830 Art. 22, provide publication independently of documentary review without printing the old 30-day publication phrase. Do not treat the table as a guaranteed pre-implementation wait or as approval for any combined transfer.

Under Decree 10178 Arts. 10–15, the approval period starts when all necessary instruction elements are submitted; the authority must state the deadline. A documentary-complement request can suspend the clock, with the stated new-fact exception. These provisions do not create a universal 60-day or 90-day device alteration period.

The successor is responsible for remaining finished stock. Finished stock produced before the individual transfer/cancellation resolutions take effect may be imported or sold for at most180 days after that effective date. Outdated packaging cannot be used for new lots produced afterwards. Unless otherwise stated, those individual resolutions take effect90 days after publication. These180/90-day periods are stock/effect rules, not agency review periods.

RDC 591 Annex II2.9 as amended by RDC 884 requires a new UDI-DI where a change could create identification ambiguity, and expressly for trade/commercial-model name changes. Under2.12 a label change solely to add UDI is not itself a regularization-change petition. A customer’s internal REF is not automatically a commercial model or UDI-DI; establish what registered and issued identifiers actually change.

IN 426 Art. 8 requires completion of the formal RDC 903 holder transfer before SIUD data transfer; successor data are transmitted for the new registration numbers within 30 days after the individual transfer/cancellation resolutions take effect. Art. 7§3 separately gives30 calendar days from publication for replacement where the change requires a new UDI-DI. These data deadlines are not agency variation-review periods.

The official registered-device alteration FAQ says that a petition permits only its requested alteration item and other inserted alterations are disregarded. This must be read with the legal rule requiring an interdependent immediate change to accompany the approval-required change. It does not authorize combining every name/address/REF/holder change into one fee or decision.

File the applicable petition subject, the fee or exemption where applicable, a declaration listing the requested alterations, and documentary evidence supporting them. A single label mock-up does not replace the subject-specific technical dossier or manufacturer evidence.

Registered IVD commercial-name change subject 8007 requires updated primary/secondary label images, updated IFU/manual, a digitally signed technical-responsible declaration listing the changes, and affected portions of the technical dossier.

Subject8020 is exclusively a foreign legal-manufacturer or manufacturing-unit corporate-name change. Supply label/IFU updates or justified no-impact statements, the manufacturer’s reason document, the imported legal-manufacturer authorization where its name changes, the updated Anvisa GMP certificate or protocol where the plant name changes, and affected dossier sections. Address/process changes use their pertinent subjects; corporate purchase, sale, merger or division is a manufacturer/site change, not this name-only subject.

Subject8011 requires updated labels and IFU, a technical-responsible signed change declaration identifying the manufacturer, the apostilled/consularized imported-manufacturer authorization and GMP undertaking, and affected dossier sections. Multiple legal manufacturers need same-group proof. If the legal manufacturer is itself the factory, include the updated Anvisa GMP certificate or protocol and also file the approval-required manufacturing-site alteration.

IVD transfer subject 80074 (product) and80078 (family) require the RDC 903 Annex I declaration digitally signed by legal and technical responsibles, the updated operating/sanitary licence and an Anvisa GMP certificate in the successor’s name or its application protocol. Parent RDC 903 Art. 30 also requires the petition form and TFVS payment/exemption. The family subject is not proof that an arbitrary collection of products qualifies as a family.