Vietnam medical device regulations

For Class C/D devices and IVDs, Article 32(7) lists owner/holder name and address, manufacturer name/address, packaging, warranty and qualifying label/IFU updates. Notify with related documents and update the public dossier within ten working days. Article29(1)(b) requires a new circulation number for the listed substantive changes, including a new product owner or added product code, and changes outside32(7).

Circular44/2025 Form 13(A/B) and Form 14(C/D) identify the existing number and show previously declared/issued information beside updated information, with related documents and a signed/stamped or digital-signature commitment. Update all affected dossier evidence consistently; these forms are not a transfer approval or a replacement for a new application when Article28(3) or29(1)(b) is triggered.

First map a commercial order REF to the declared or registered product code/type and label. An added product code triggers a fresh A/B declaration or C/D circulation-number application under 28(3)/29(1)(b); A/B reductions are specifically listed under 28(4)(g). Article 32a permits a priority request where the old code was discontinued and the prescribed device-type facts remain unchanged. Its ten-working-day decision is priority acceptance, not final registration approval.

Articles28(4)(e) and32(7)(e) permit devices manufactured before the holder gives the qualifying label-change notice to continue circulating with the information declared/registered and updated at manufacture. A/B must keep intended purpose and indications unchanged; C/D must also keep functionality and performance unchanged. This is not a general stock grace after a new product-owner transfer or a substantive code/type change.

The retained A/B procedure in2075/QĐ-BYT requires the holder/distributor commitment dossier no later than60 days after the specified cessation, bankruptcy or dissolution event. The provincial health authority answers within 15 working days of a valid dossier; continued circulation is limited to24 months under the stated warranty/maintenance/material-support commitments, including the eight-year support wording and its exceptions. This is not an ordinary rename or transfer grace.

A fresh A/B dossier under 26-27 includes the applicable ISO 13485, owner authorisation, warranty evidence, technical description/standards, IFU, label and current imported-device CFS. Reagent/calibrator/control IVDs have their specifically listed technical and quality evidence. A new C/D dossier follows its Article 30 route and31 document/legalisation requirements, including the applicable CSDT and IVD quality certificate branches. Apply current Circular44 forms and owner-LOA/warranty templates.

The retained A/B CFS procedure in2075/QĐ-BYT uses the provincial health authority, an application with owner/manufacturer/device/brand/code/circulation-number information and valid ISO 13485 evidence in the prescribed form. The procedure gives up to three working days from a complete proper dossier, with inspection possible where document review is insufficient. It is an export certificate requested to meet an importing-country requirement, not an automatic reissue after every logo or name edit.

The C/D CFS procedure in3618/QĐ-BYT directs Form 11 under Circular44/2025 and the quality-certificate evidence to IMDA. It gives up to three working days from a complete proper dossier, allows inspection where needed and lists a VND 500000 export-dossier fee in the temporary fee framework. The form distinguishes owner, applicant, manufacturer, device type/code and circulation number. It is separate from change notification and does not itself require CFS reissue for every change.

An IVD circulating in Vietnam must meet Article22 label requirements and have Vietnamese instructions for use, with the stated warranty-information exceptions. Where IFU or warranty information is provided electronically rather than accompanying the device, the label must clearly show how to retrieve it. A brand, owner or REF change must be aligned with the actual label and current dossier; the language rule does not itself decide the filing route.

For Class C/D devices and IVDs, Article 32(7) lists owner/holder name and address, manufacturer name/address, packaging, warranty and qualifying label/IFU updates. Notify with related documents and update the public dossier within ten working days. Article29(1)(b) requires a new circulation number for the listed substantive changes, including a new product owner or added product code, and changes outside32(7).

Circular44/2025 Form 13(A/B) and Form 14(C/D) identify the existing number and show previously declared/issued information beside updated information, with related documents and a signed/stamped or digital-signature commitment. Update all affected dossier evidence consistently; these forms are not a transfer approval or a replacement for a new application when Article28(3) or29(1)(b) is triggered.

First map a commercial order REF to the declared or registered product code/type and label. An added product code triggers a fresh A/B declaration or C/D circulation-number application under 28(3)/29(1)(b); A/B reductions are specifically listed under 28(4)(g). Article 32a permits a priority request where the old code was discontinued and the prescribed device-type facts remain unchanged. Its ten-working-day decision is priority acceptance, not final registration approval.

Articles28(4)(e) and32(7)(e) permit devices manufactured before the holder gives the qualifying label-change notice to continue circulating with the information declared/registered and updated at manufacture. A/B must keep intended purpose and indications unchanged; C/D must also keep functionality and performance unchanged. This is not a general stock grace after a new product-owner transfer or a substantive code/type change.

The retained A/B procedure in2075/QĐ-BYT requires the holder/distributor commitment dossier no later than60 days after the specified cessation, bankruptcy or dissolution event. The provincial health authority answers within 15 working days of a valid dossier; continued circulation is limited to24 months under the stated warranty/maintenance/material-support commitments, including the eight-year support wording and its exceptions. This is not an ordinary rename or transfer grace.

A fresh A/B dossier under 26-27 includes the applicable ISO 13485, owner authorisation, warranty evidence, technical description/standards, IFU, label and current imported-device CFS. Reagent/calibrator/control IVDs have their specifically listed technical and quality evidence. A new C/D dossier follows its Article 30 route and31 document/legalisation requirements, including the applicable CSDT and IVD quality certificate branches. Apply current Circular44 forms and owner-LOA/warranty templates.

The retained A/B CFS procedure in2075/QĐ-BYT uses the provincial health authority, an application with owner/manufacturer/device/brand/code/circulation-number information and valid ISO 13485 evidence in the prescribed form. The procedure gives up to three working days from a complete proper dossier, with inspection possible where document review is insufficient. It is an export certificate requested to meet an importing-country requirement, not an automatic reissue after every logo or name edit.

The C/D CFS procedure in3618/QĐ-BYT directs Form 11 under Circular44/2025 and the quality-certificate evidence to IMDA. It gives up to three working days from a complete proper dossier, allows inspection where needed and lists a VND 500000 export-dossier fee in the temporary fee framework. The form distinguishes owner, applicant, manufacturer, device type/code and circulation number. It is separate from change notification and does not itself require CFS reissue for every change.

An IVD circulating in Vietnam must meet Article22 label requirements and have Vietnamese instructions for use, with the stated warranty-information exceptions. Where IFU or warranty information is provided electronically rather than accompanying the device, the label must clearly show how to retrieve it. A brand, owner or REF change must be aligned with the actual label and current dossier; the language rule does not itself decide the filing route.

For Class C/D devices and IVDs, Article 32(7) lists owner/holder name and address, manufacturer name/address, packaging, warranty and qualifying label/IFU updates. Notify with related documents and update the public dossier within ten working days. Article29(1)(b) requires a new circulation number for the listed substantive changes, including a new product owner or added product code, and changes outside32(7).

Circular44/2025 Form 13(A/B) and Form 14(C/D) identify the existing number and show previously declared/issued information beside updated information, with related documents and a signed/stamped or digital-signature commitment. Update all affected dossier evidence consistently; these forms are not a transfer approval or a replacement for a new application when Article28(3) or29(1)(b) is triggered.

First map a commercial order REF to the declared or registered product code/type and label. An added product code triggers a fresh A/B declaration or C/D circulation-number application under 28(3)/29(1)(b); A/B reductions are specifically listed under 28(4)(g). Article 32a permits a priority request where the old code was discontinued and the prescribed device-type facts remain unchanged. Its ten-working-day decision is priority acceptance, not final registration approval.

Articles28(4)(e) and32(7)(e) permit devices manufactured before the holder gives the qualifying label-change notice to continue circulating with the information declared/registered and updated at manufacture. A/B must keep intended purpose and indications unchanged; C/D must also keep functionality and performance unchanged. This is not a general stock grace after a new product-owner transfer or a substantive code/type change.

The retained A/B procedure in2075/QĐ-BYT requires the holder/distributor commitment dossier no later than60 days after the specified cessation, bankruptcy or dissolution event. The provincial health authority answers within 15 working days of a valid dossier; continued circulation is limited to24 months under the stated warranty/maintenance/material-support commitments, including the eight-year support wording and its exceptions. This is not an ordinary rename or transfer grace.

A fresh A/B dossier under 26-27 includes the applicable ISO 13485, owner authorisation, warranty evidence, technical description/standards, IFU, label and current imported-device CFS. Reagent/calibrator/control IVDs have their specifically listed technical and quality evidence. A new C/D dossier follows its Article 30 route and31 document/legalisation requirements, including the applicable CSDT and IVD quality certificate branches. Apply current Circular44 forms and owner-LOA/warranty templates.

The retained A/B CFS procedure in2075/QĐ-BYT uses the provincial health authority, an application with owner/manufacturer/device/brand/code/circulation-number information and valid ISO 13485 evidence in the prescribed form. The procedure gives up to three working days from a complete proper dossier, with inspection possible where document review is insufficient. It is an export certificate requested to meet an importing-country requirement, not an automatic reissue after every logo or name edit.

The C/D CFS procedure in3618/QĐ-BYT directs Form 11 under Circular44/2025 and the quality-certificate evidence to IMDA. It gives up to three working days from a complete proper dossier, allows inspection where needed and lists a VND 500000 export-dossier fee in the temporary fee framework. The form distinguishes owner, applicant, manufacturer, device type/code and circulation number. It is separate from change notification and does not itself require CFS reissue for every change.

An IVD circulating in Vietnam must meet Article22 label requirements and have Vietnamese instructions for use, with the stated warranty-information exceptions. Where IFU or warranty information is provided electronically rather than accompanying the device, the label must clearly show how to retrieve it. A brand, owner or REF change must be aligned with the actual label and current dossier; the language rule does not itself decide the filing route.

For Class C/D devices and IVDs, Article 32(7) lists owner/holder name and address, manufacturer name/address, packaging, warranty and qualifying label/IFU updates. Notify with related documents and update the public dossier within ten working days. Article29(1)(b) requires a new circulation number for the listed substantive changes, including a new product owner or added product code, and changes outside32(7).

Circular44/2025 Form 13(A/B) and Form 14(C/D) identify the existing number and show previously declared/issued information beside updated information, with related documents and a signed/stamped or digital-signature commitment. Update all affected dossier evidence consistently; these forms are not a transfer approval or a replacement for a new application when Article28(3) or29(1)(b) is triggered.

First map a commercial order REF to the declared or registered product code/type and label. An added product code triggers a fresh A/B declaration or C/D circulation-number application under 28(3)/29(1)(b); A/B reductions are specifically listed under 28(4)(g). Article 32a permits a priority request where the old code was discontinued and the prescribed device-type facts remain unchanged. Its ten-working-day decision is priority acceptance, not final registration approval.

A fresh A/B dossier under 26-27 includes the applicable ISO 13485, owner authorisation, warranty evidence, technical description/standards, IFU, label and current imported-device CFS. Reagent/calibrator/control IVDs have their specifically listed technical and quality evidence. A new C/D dossier follows its Article 30 route and31 document/legalisation requirements, including the applicable CSDT and IVD quality certificate branches. Apply current Circular44 forms and owner-LOA/warranty templates.

VND 500,000

Per dossier

Current amount is 50% of the VND 1,000,000 base fee in Circular 59/2023.

VND 1,500,000

Per dossier

Current amount is 50% of the VND 3,000,000 base fee in Circular 59/2023.

VND 3,000,000

Per dossier

Current amount is 50% of the VND 6,000,000 base fee in Circular 59/2023.

Where the change requires a new C/D application, Article 32 distinguishes30 calendar days for the specified Article 30(1)-(2) routes, ten working days for the fast and emergency routes, and45 calendar days for the other-device route, from a complete valid dossier including fee evidence if no amendment is requested. Deficiency-notice periods and90-day applicant-response/repeated-amendment limits are separate. None of these clocks is a review period for a five/ten-day change notification.

Articles28(4)(e) and32(7)(e) permit devices manufactured before the holder gives the qualifying label-change notice to continue circulating with the information declared/registered and updated at manufacture. A/B must keep intended purpose and indications unchanged; C/D must also keep functionality and performance unchanged. This is not a general stock grace after a new product-owner transfer or a substantive code/type change.

The retained A/B procedure in2075/QĐ-BYT requires the holder/distributor commitment dossier no later than60 days after the specified cessation, bankruptcy or dissolution event. The provincial health authority answers within 15 working days of a valid dossier; continued circulation is limited to24 months under the stated warranty/maintenance/material-support commitments, including the eight-year support wording and its exceptions. This is not an ordinary rename or transfer grace.

The retained A/B CFS procedure in2075/QĐ-BYT uses the provincial health authority, an application with owner/manufacturer/device/brand/code/circulation-number information and valid ISO 13485 evidence in the prescribed form. The procedure gives up to three working days from a complete proper dossier, with inspection possible where document review is insufficient. It is an export certificate requested to meet an importing-country requirement, not an automatic reissue after every logo or name edit.

The C/D CFS procedure in3618/QĐ-BYT directs Form 11 under Circular44/2025 and the quality-certificate evidence to IMDA. It gives up to three working days from a complete proper dossier, allows inspection where needed and lists a VND 500000 export-dossier fee in the temporary fee framework. The form distinguishes owner, applicant, manufacturer, device type/code and circulation number. It is separate from change notification and does not itself require CFS reissue for every change.

An IVD circulating in Vietnam must meet Article22 label requirements and have Vietnamese instructions for use, with the stated warranty-information exceptions. Where IFU or warranty information is provided electronically rather than accompanying the device, the label must clearly show how to retrieve it. A brand, owner or REF change must be aligned with the actual label and current dossier; the language rule does not itself decide the filing route.

For Class C/D devices and IVDs, Article 32(7) lists owner/holder name and address, manufacturer name/address, packaging, warranty and qualifying label/IFU updates. Notify with related documents and update the public dossier within ten working days. Article29(1)(b) requires a new circulation number for the listed substantive changes, including a new product owner or added product code, and changes outside32(7).

Circular44/2025 Form 13(A/B) and Form 14(C/D) identify the existing number and show previously declared/issued information beside updated information, with related documents and a signed/stamped or digital-signature commitment. Update all affected dossier evidence consistently; these forms are not a transfer approval or a replacement for a new application when Article28(3) or29(1)(b) is triggered.

A real change of product owner triggers a fresh A/B declaration or C/D circulation-number application under 28(3)/29(1)(b); a name-only update of the same owner is different. The local declarant/registrant must be eligible under Article 25 and hold the applicable owner authorisation and warranty support. A different local importer or registrant is separately recognised in the conditional priority process of32a; it is not an unrestricted transfer of the existing number.

A fresh A/B dossier under 26-27 includes the applicable ISO 13485, owner authorisation, warranty evidence, technical description/standards, IFU, label and current imported-device CFS. Reagent/calibrator/control IVDs have their specifically listed technical and quality evidence. A new C/D dossier follows its Article 30 route and31 document/legalisation requirements, including the applicable CSDT and IVD quality certificate branches. Apply current Circular44 forms and owner-LOA/warranty templates.

VND 500,000

Per dossier

Current amount is 50% of the VND 1,000,000 base fee in Circular 59/2023.

VND 1,500,000

Per dossier

Current amount is 50% of the VND 3,000,000 base fee in Circular 59/2023.

VND 3,000,000

Per dossier

Current amount is 50% of the VND 6,000,000 base fee in Circular 59/2023.

Where the change requires a new C/D application, Article 32 distinguishes30 calendar days for the specified Article 30(1)-(2) routes, ten working days for the fast and emergency routes, and45 calendar days for the other-device route, from a complete valid dossier including fee evidence if no amendment is requested. Deficiency-notice periods and90-day applicant-response/repeated-amendment limits are separate. None of these clocks is a review period for a five/ten-day change notification.

First map a commercial order REF to the declared or registered product code/type and label. An added product code triggers a fresh A/B declaration or C/D circulation-number application under 28(3)/29(1)(b); A/B reductions are specifically listed under 28(4)(g). Article 32a permits a priority request where the old code was discontinued and the prescribed device-type facts remain unchanged. Its ten-working-day decision is priority acceptance, not final registration approval.

Articles28(4)(e) and32(7)(e) permit devices manufactured before the holder gives the qualifying label-change notice to continue circulating with the information declared/registered and updated at manufacture. A/B must keep intended purpose and indications unchanged; C/D must also keep functionality and performance unchanged. This is not a general stock grace after a new product-owner transfer or a substantive code/type change.

The retained A/B procedure in2075/QĐ-BYT requires the holder/distributor commitment dossier no later than60 days after the specified cessation, bankruptcy or dissolution event. The provincial health authority answers within 15 working days of a valid dossier; continued circulation is limited to24 months under the stated warranty/maintenance/material-support commitments, including the eight-year support wording and its exceptions. This is not an ordinary rename or transfer grace.

The retained A/B CFS procedure in2075/QĐ-BYT uses the provincial health authority, an application with owner/manufacturer/device/brand/code/circulation-number information and valid ISO 13485 evidence in the prescribed form. The procedure gives up to three working days from a complete proper dossier, with inspection possible where document review is insufficient. It is an export certificate requested to meet an importing-country requirement, not an automatic reissue after every logo or name edit.

The C/D CFS procedure in3618/QĐ-BYT directs Form 11 under Circular44/2025 and the quality-certificate evidence to IMDA. It gives up to three working days from a complete proper dossier, allows inspection where needed and lists a VND 500000 export-dossier fee in the temporary fee framework. The form distinguishes owner, applicant, manufacturer, device type/code and circulation number. It is separate from change notification and does not itself require CFS reissue for every change.

An IVD circulating in Vietnam must meet Article22 label requirements and have Vietnamese instructions for use, with the stated warranty-information exceptions. Where IFU or warranty information is provided electronically rather than accompanying the device, the label must clearly show how to retrieve it. A brand, owner or REF change must be aligned with the actual label and current dossier; the language rule does not itself decide the filing route.

For Class C/D devices and IVDs, Article 32(7) lists owner/holder name and address, manufacturer name/address, packaging, warranty and qualifying label/IFU updates. Notify with related documents and update the public dossier within ten working days. Article29(1)(b) requires a new circulation number for the listed substantive changes, including a new product owner or added product code, and changes outside32(7).

Circular44/2025 Form 13(A/B) and Form 14(C/D) identify the existing number and show previously declared/issued information beside updated information, with related documents and a signed/stamped or digital-signature commitment. Update all affected dossier evidence consistently; these forms are not a transfer approval or a replacement for a new application when Article28(3) or29(1)(b) is triggered.

First map a commercial order REF to the declared or registered product code/type and label. An added product code triggers a fresh A/B declaration or C/D circulation-number application under 28(3)/29(1)(b); A/B reductions are specifically listed under 28(4)(g). Article 32a permits a priority request where the old code was discontinued and the prescribed device-type facts remain unchanged. Its ten-working-day decision is priority acceptance, not final registration approval.

A real change of product owner triggers a fresh A/B declaration or C/D circulation-number application under 28(3)/29(1)(b); a name-only update of the same owner is different. The local declarant/registrant must be eligible under Article 25 and hold the applicable owner authorisation and warranty support. A different local importer or registrant is separately recognised in the conditional priority process of32a; it is not an unrestricted transfer of the existing number.

A fresh A/B dossier under 26-27 includes the applicable ISO 13485, owner authorisation, warranty evidence, technical description/standards, IFU, label and current imported-device CFS. Reagent/calibrator/control IVDs have their specifically listed technical and quality evidence. A new C/D dossier follows its Article 30 route and31 document/legalisation requirements, including the applicable CSDT and IVD quality certificate branches. Apply current Circular44 forms and owner-LOA/warranty templates.

VND 500,000

Per dossier

Current amount is 50% of the VND 1,000,000 base fee in Circular 59/2023.

VND 1,500,000

Per dossier

Current amount is 50% of the VND 3,000,000 base fee in Circular 59/2023.

VND 3,000,000

Per dossier

Current amount is 50% of the VND 6,000,000 base fee in Circular 59/2023.

Where the change requires a new C/D application, Article 32 distinguishes30 calendar days for the specified Article 30(1)-(2) routes, ten working days for the fast and emergency routes, and45 calendar days for the other-device route, from a complete valid dossier including fee evidence if no amendment is requested. Deficiency-notice periods and90-day applicant-response/repeated-amendment limits are separate. None of these clocks is a review period for a five/ten-day change notification.

Articles28(4)(e) and32(7)(e) permit devices manufactured before the holder gives the qualifying label-change notice to continue circulating with the information declared/registered and updated at manufacture. A/B must keep intended purpose and indications unchanged; C/D must also keep functionality and performance unchanged. This is not a general stock grace after a new product-owner transfer or a substantive code/type change.

The retained A/B procedure in2075/QĐ-BYT requires the holder/distributor commitment dossier no later than60 days after the specified cessation, bankruptcy or dissolution event. The provincial health authority answers within 15 working days of a valid dossier; continued circulation is limited to24 months under the stated warranty/maintenance/material-support commitments, including the eight-year support wording and its exceptions. This is not an ordinary rename or transfer grace.

The retained A/B CFS procedure in2075/QĐ-BYT uses the provincial health authority, an application with owner/manufacturer/device/brand/code/circulation-number information and valid ISO 13485 evidence in the prescribed form. The procedure gives up to three working days from a complete proper dossier, with inspection possible where document review is insufficient. It is an export certificate requested to meet an importing-country requirement, not an automatic reissue after every logo or name edit.

The C/D CFS procedure in3618/QĐ-BYT directs Form 11 under Circular44/2025 and the quality-certificate evidence to IMDA. It gives up to three working days from a complete proper dossier, allows inspection where needed and lists a VND 500000 export-dossier fee in the temporary fee framework. The form distinguishes owner, applicant, manufacturer, device type/code and circulation number. It is separate from change notification and does not itself require CFS reissue for every change.

An IVD circulating in Vietnam must meet Article22 label requirements and have Vietnamese instructions for use, with the stated warranty-information exceptions. Where IFU or warranty information is provided electronically rather than accompanying the device, the label must clearly show how to retrieve it. A brand, owner or REF change must be aligned with the actual label and current dossier; the language rule does not itself decide the filing route.