Brazil medical device regulations

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.

Information on labels and in instructions for use must be written in Portuguese.

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.

The official material/equipment notification forms identify the local applicant, legal manufacturer and individual manufacturing plants separately. For families they request commercial model codes/descriptions as stated, together with product/presentation information, applicable conformity-certification particulars and signed legal/technical declarations that labels and IFU meet RDC 751. These fields help distinguish an office identity update from a factory or model change; the form alone does not replace a registered subject’s checklist.

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.

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.

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 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.

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.

The official material/equipment notification forms identify the local applicant, legal manufacturer and individual manufacturing plants separately. For families they request commercial model codes/descriptions as stated, together with product/presentation information, applicable conformity-certification particulars and signed legal/technical declarations that labels and IFU meet RDC 751. These fields help distinguish an office identity update from a factory or model change; the form alone does not replace a registered subject’s checklist.

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.

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.

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.

Information on labels and in instructions for use must be written in Portuguese.

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.

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.

The official notification-alteration FAQ permits more than one alteration in the same notification petition if every alteration is identified in the form and declaration. Omitted alterations risk refusal. This does not transfer a notification to another holder or authorize batching different regularizations.

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.

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.

The official material/equipment notification forms identify the local applicant, legal manufacturer and individual manufacturing plants separately. For families they request commercial model codes/descriptions as stated, together with product/presentation information, applicable conformity-certification particulars and signed legal/technical declarations that labels and IFU meet RDC 751. These fields help distinguish an office identity update from a factory or model change; the form alone does not replace a registered subject’s checklist.

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.

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.

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.

Information on labels and in instructions for use must be written in Portuguese.

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.

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.

The official notification-alteration FAQ permits more than one alteration in the same notification petition if every alteration is identified in the form and declaration. Omitted alterations risk refusal. This does not transfer a notification to another holder or authorize batching different regularizations.

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.

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.

The official material/equipment notification forms identify the local applicant, legal manufacturer and individual manufacturing plants separately. For families they request commercial model codes/descriptions as stated, together with product/presentation information, applicable conformity-certification particulars and signed legal/technical declarations that labels and IFU meet RDC 751. These fields help distinguish an office identity update from a factory or model change; the form alone does not replace a registered subject’s checklist.

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.

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.

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.

Information on labels and in instructions for use must be written in Portuguese.

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.

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.

The official notification-alteration FAQ permits more than one alteration in the same notification petition if every alteration is identified in the form and declaration. Omitted alterations risk refusal. This does not transfer a notification to another holder or authorize batching different regularizations.

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.

Information on labels and in instructions for use must be written in Portuguese.

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.

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.

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.

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.

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.

The official material/equipment notification forms identify the local applicant, legal manufacturer and individual manufacturing plants separately. For families they request commercial model codes/descriptions as stated, together with product/presentation information, applicable conformity-certification particulars and signed legal/technical declarations that labels and IFU meet RDC 751. These fields help distinguish an office identity update from a factory or model change; the form alone does not replace a registered subject’s checklist.

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.

Information on labels and in instructions for use must be written in Portuguese.

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.

The official notification-alteration FAQ permits more than one alteration in the same notification petition if every alteration is identified in the form and declaration. Omitted alterations risk refusal. This does not transfer a notification to another holder or authorize batching different regularizations.