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.

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 medical device may only circulate on the Vietnamese market if it has a label carrying the complete information required by the current goods-labelling legislation and is supplied with instructions for use for the medical device in Vietnamese, together with warranty-service, warranty-condition and warranty-period information where the exceptions in Art. 22(1)(d) and 22(2) do not apply.

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.

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 medical device may only circulate on the Vietnamese market if it has a label carrying the complete information required by the current goods-labelling legislation and is supplied with instructions for use for the medical device in Vietnamese, together with warranty-service, warranty-condition and warranty-period information where the exceptions in Art. 22(1)(d) and 22(2) do not apply.

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.

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.

A medical device may only circulate on the Vietnamese market if it has a label carrying the complete information required by the current goods-labelling legislation and is supplied with instructions for use for the medical device in Vietnamese, together with warranty-service, warranty-condition and warranty-period information where the exceptions in Art. 22(1)(d) and 22(2) do not apply.

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.

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.

A medical device may only circulate on the Vietnamese market if it has a label carrying the complete information required by the current goods-labelling legislation and is supplied with instructions for use for the medical device in Vietnamese, together with warranty-service, warranty-condition and warranty-period information where the exceptions in Art. 22(1)(d) and 22(2) do not apply.

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.

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.

A medical device may only circulate on the Vietnamese market if it has a label carrying the complete information required by the current goods-labelling legislation and is supplied with instructions for use for the medical device in Vietnamese, together with warranty-service, warranty-condition and warranty-period information where the exceptions in Art. 22(1)(d) and 22(2) do not apply.

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.