Malaysia medical device regulations

A logo or layout edit must be checked against GD0020 5.6.3. Other label-information changes can be Category 3; the listed no-CN exceptions cover rephrasing/reordering IFU information, adding/removing languages not required by MDA, and distributor information that does not affect registered information. A new device name or registered identifier is assessed separately under the Category 2 row; a logo edit is not automatically exempt.

MDA announcement1799 makes GD0072 implementation conditional on the formal launch of MeDC@St3.0. The 14 October2026 re-registration guide still describes3.0 as under development, with a December2026 target and a further announcement before implementation. Use GD0020 for the recorded current CN answer unless a formal launch changes that condition. The automated2.0+ renewal route requires no active/pending CN or COO for the device.

The Category 2 name/identifier row requires a declaration of conformity, a manufacturer declaration that the device is unchanged including intended use and technical specifications, updated configurations identifying affected devices, labels showing every amended section and annexes. The summary must state present/proposed information and reasons for all related changes.

The official CN fee table charges Category 2 RM 50/500/1000/1500 for Classes A/B/C/D respectively, or RM 2500 for a device containing a medicinal product; Category 3 is RM 30 across the merged class column. For a single ID with both categories, add the category fees; for multiple IDs multiply each applicable category fee by its ID count. The printed three-Class B-ID Category 2+3 example totals RM 1590.

GD0020 Table 5 lists30 working days for a single submission ID in Category 2 or3,60 working days for a single ID combining2+3, and60 working days for multiple IDs. These targets start with a complete application and supporting documents. Category 2 still requires endorsement before implementation; Category 3 may be implemented on complete submission rather than waiting for that administrative target.

GD0026 Seventh Edition requires device name/model and manufacturer information, plus the applicable local manufacturer/AR contact and IVD particulars. Labelling compliance may be completed after import or manufacture but before market placement; added AR/importer/translation labels must preserve the specified original traceability/date information. Changes to electronic labels follow GD0020, and corresponding paper IFUs must remain aligned.

A logo or layout edit must be checked against GD0020 5.6.3. Other label-information changes can be Category 3; the listed no-CN exceptions cover rephrasing/reordering IFU information, adding/removing languages not required by MDA, and distributor information that does not affect registered information. A new device name or registered identifier is assessed separately under the Category 2 row; a logo edit is not automatically exempt.

MDA announcement1799 makes GD0072 implementation conditional on the formal launch of MeDC@St3.0. The 14 October2026 re-registration guide still describes3.0 as under development, with a December2026 target and a further announcement before implementation. Use GD0020 for the recorded current CN answer unless a formal launch changes that condition. The automated2.0+ renewal route requires no active/pending CN or COO for the device.

GD0020 Table 2 5.6.4(c) assigns manufacturer registered-name or administrative-office-address changes, and manufacturing-site-name-only changes with no site-address change, to Category 3. These changes may be implemented after complete documents are submitted. A physical manufacturing-site move has a different Category 2 branch; it is not assumed for an office-only change.

Labels must not state or imply that marketing or use of the device is encouraged or endorsed by the Authority or Ministry of Health (fine up to RM10,000 and/or 3 months); labels must be clear, indelible and legible; the Sixth Schedule requires device identification (name, model, lot/serial, manufacture and expiry dates), manufacturer details and, for foreign-made devices, the authorised representative's name, address and contact number.

The Category 2 name/identifier row requires a declaration of conformity, a manufacturer declaration that the device is unchanged including intended use and technical specifications, updated configurations identifying affected devices, labels showing every amended section and annexes. The summary must state present/proposed information and reasons for all related changes.

The Category 3 manufacturer-information row calls for a declaration of conformity, the manufacturer undertaking to support devices already supplied under its former name where applicable, amended labels, an updated QMS certificate or relevant official evidence of the change, and annexes. The undertaking is post-market support evidence; it does not grant an unrestricted old-label sell-through period.

The official CN fee table charges Category 2 RM 50/500/1000/1500 for Classes A/B/C/D respectively, or RM 2500 for a device containing a medicinal product; Category 3 is RM 30 across the merged class column. For a single ID with both categories, add the category fees; for multiple IDs multiply each applicable category fee by its ID count. The printed three-Class B-ID Category 2+3 example totals RM 1590.

GD0020 Table 5 lists30 working days for a single submission ID in Category 2 or3,60 working days for a single ID combining2+3, and60 working days for multiple IDs. These targets start with a complete application and supporting documents. Category 2 still requires endorsement before implementation; Category 3 may be implemented on complete submission rather than waiting for that administrative target.

GD0026 Seventh Edition requires device name/model and manufacturer information, plus the applicable local manufacturer/AR contact and IVD particulars. Labelling compliance may be completed after import or manufacture but before market placement; added AR/importer/translation labels must preserve the specified original traceability/date information. Changes to electronic labels follow GD0020, and corresponding paper IFUs must remain aligned.

The official FAQ permits any Category 2/3 changes for one medical device in one CN. Combining2-50 devices requires similar changes and is limited to the listed types, including specified facility/QMS/manufacturer-name or administrative-address changes. A pending CN for the same device must finish before another CN can be submitted. List every related change in Annex B; this permission does not combine an ownership transfer automatically.

A logo or layout edit must be checked against GD0020 5.6.3. Other label-information changes can be Category 3; the listed no-CN exceptions cover rephrasing/reordering IFU information, adding/removing languages not required by MDA, and distributor information that does not affect registered information. A new device name or registered identifier is assessed separately under the Category 2 row; a logo edit is not automatically exempt.

MDA announcement1799 makes GD0072 implementation conditional on the formal launch of MeDC@St3.0. The 14 October2026 re-registration guide still describes3.0 as under development, with a December2026 target and a further announcement before implementation. Use GD0020 for the recorded current CN answer unless a formal launch changes that condition. The automated2.0+ renewal route requires no active/pending CN or COO for the device.

GD0020 Table 2 5.6.4(c) assigns manufacturer registered-name or administrative-office-address changes, and manufacturing-site-name-only changes with no site-address change, to Category 3. These changes may be implemented after complete documents are submitted. A physical manufacturing-site move has a different Category 2 branch; it is not assumed for an office-only change.

The Category 2 name/identifier row requires a declaration of conformity, a manufacturer declaration that the device is unchanged including intended use and technical specifications, updated configurations identifying affected devices, labels showing every amended section and annexes. The summary must state present/proposed information and reasons for all related changes.

The Category 3 manufacturer-information row calls for a declaration of conformity, the manufacturer undertaking to support devices already supplied under its former name where applicable, amended labels, an updated QMS certificate or relevant official evidence of the change, and annexes. The undertaking is post-market support evidence; it does not grant an unrestricted old-label sell-through period.

The official CN fee table charges Category 2 RM 50/500/1000/1500 for Classes A/B/C/D respectively, or RM 2500 for a device containing a medicinal product; Category 3 is RM 30 across the merged class column. For a single ID with both categories, add the category fees; for multiple IDs multiply each applicable category fee by its ID count. The printed three-Class B-ID Category 2+3 example totals RM 1590.

GD0020 Table 5 lists30 working days for a single submission ID in Category 2 or3,60 working days for a single ID combining2+3, and60 working days for multiple IDs. These targets start with a complete application and supporting documents. Category 2 still requires endorsement before implementation; Category 3 may be implemented on complete submission rather than waiting for that administrative target.

GD0026 Seventh Edition requires device name/model and manufacturer information, plus the applicable local manufacturer/AR contact and IVD particulars. Labelling compliance may be completed after import or manufacture but before market placement; added AR/importer/translation labels must preserve the specified original traceability/date information. Changes to electronic labels follow GD0020, and corresponding paper IFUs must remain aligned.

The official FAQ permits any Category 2/3 changes for one medical device in one CN. Combining2-50 devices requires similar changes and is limited to the listed types, including specified facility/QMS/manufacturer-name or administrative-address changes. A pending CN for the same device must finish before another CN can be submitted. List every related change in Annex B; this permission does not combine an ownership transfer automatically.

A logo or layout edit must be checked against GD0020 5.6.3. Other label-information changes can be Category 3; the listed no-CN exceptions cover rephrasing/reordering IFU information, adding/removing languages not required by MDA, and distributor information that does not affect registered information. A new device name or registered identifier is assessed separately under the Category 2 row; a logo edit is not automatically exempt.

MDA announcement1799 makes GD0072 implementation conditional on the formal launch of MeDC@St3.0. The 14 October2026 re-registration guide still describes3.0 as under development, with a December2026 target and a further announcement before implementation. Use GD0020 for the recorded current CN answer unless a formal launch changes that condition. The automated2.0+ renewal route requires no active/pending CN or COO for the device.

Labels must not state or imply that marketing or use of the device is encouraged or endorsed by the Authority or Ministry of Health (fine up to RM10,000 and/or 3 months); labels must be clear, indelible and legible; the Sixth Schedule requires device identification (name, model, lot/serial, manufacture and expiry dates), manufacturer details and, for foreign-made devices, the authorised representative's name, address and contact number.

The Category 2 name/identifier row requires a declaration of conformity, a manufacturer declaration that the device is unchanged including intended use and technical specifications, updated configurations identifying affected devices, labels showing every amended section and annexes. The summary must state present/proposed information and reasons for all related changes.

The official CN fee table charges Category 2 RM 50/500/1000/1500 for Classes A/B/C/D respectively, or RM 2500 for a device containing a medicinal product; Category 3 is RM 30 across the merged class column. For a single ID with both categories, add the category fees; for multiple IDs multiply each applicable category fee by its ID count. The printed three-Class B-ID Category 2+3 example totals RM 1590.

GD0020 Table 5 lists30 working days for a single submission ID in Category 2 or3,60 working days for a single ID combining2+3, and60 working days for multiple IDs. These targets start with a complete application and supporting documents. Category 2 still requires endorsement before implementation; Category 3 may be implemented on complete submission rather than waiting for that administrative target.

GD0026 Seventh Edition requires device name/model and manufacturer information, plus the applicable local manufacturer/AR contact and IVD particulars. Labelling compliance may be completed after import or manufacture but before market placement; added AR/importer/translation labels must preserve the specified original traceability/date information. Changes to electronic labels follow GD0020, and corresponding paper IFUs must remain aligned.

The official FAQ permits any Category 2/3 changes for one medical device in one CN. Combining2-50 devices requires similar changes and is limited to the listed types, including specified facility/QMS/manufacturer-name or administrative-address changes. A pending CN for the same device must finish before another CN can be submitted. List every related change in Annex B; this permission does not combine an ownership transfer automatically.

A logo or layout edit must be checked against GD0020 5.6.3. Other label-information changes can be Category 3; the listed no-CN exceptions cover rephrasing/reordering IFU information, adding/removing languages not required by MDA, and distributor information that does not affect registered information. A new device name or registered identifier is assessed separately under the Category 2 row; a logo edit is not automatically exempt.

MDA announcement1799 makes GD0072 implementation conditional on the formal launch of MeDC@St3.0. The 14 October2026 re-registration guide still describes3.0 as under development, with a December2026 target and a further announcement before implementation. Use GD0020 for the recorded current CN answer unless a formal launch changes that condition. The automated2.0+ renewal route requires no active/pending CN or COO for the device.

GD0041 provides a registration-ownership application by the new AR after registration and after pending applications are completed or withdrawn. The effective transfer date is MDA approval, not the manufacturer appointment-letter date. Its current/new AR forms and unchanged manufacturer field do not establish unrestricted substitution of a different foreign legal manufacturer.

The Category 2 name/identifier row requires a declaration of conformity, a manufacturer declaration that the device is unchanged including intended use and technical specifications, updated configurations identifying affected devices, labels showing every amended section and annexes. The summary must state present/proposed information and reasons for all related changes.

GD0041 requires Annex A signed by the new AR, its establishment licence, manufacturer LOA under GD0027 and a manufacturer request naming the devices and appointment date before submission. The current AR supplies Annex B, surrenders certificates and transfers distribution/complaints records. The guide gives approximately 30 working days from complete submission and RM 500 per registration ID; original certificate validity continues from its initial registration date.

The official CN fee table charges Category 2 RM 50/500/1000/1500 for Classes A/B/C/D respectively, or RM 2500 for a device containing a medicinal product; Category 3 is RM 30 across the merged class column. For a single ID with both categories, add the category fees; for multiple IDs multiply each applicable category fee by its ID count. The printed three-Class B-ID Category 2+3 example totals RM 1590.

GD0020 Table 5 lists30 working days for a single submission ID in Category 2 or3,60 working days for a single ID combining2+3, and60 working days for multiple IDs. These targets start with a complete application and supporting documents. Category 2 still requires endorsement before implementation; Category 3 may be implemented on complete submission rather than waiting for that administrative target.

GD0026 Seventh Edition requires device name/model and manufacturer information, plus the applicable local manufacturer/AR contact and IVD particulars. Labelling compliance may be completed after import or manufacture but before market placement; added AR/importer/translation labels must preserve the specified original traceability/date information. Changes to electronic labels follow GD0020, and corresponding paper IFUs must remain aligned.

The official FAQ permits any Category 2/3 changes for one medical device in one CN. Combining2-50 devices requires similar changes and is limited to the listed types, including specified facility/QMS/manufacturer-name or administrative-address changes. A pending CN for the same device must finish before another CN can be submitted. List every related change in Annex B; this permission does not combine an ownership transfer automatically.

A logo or layout edit must be checked against GD0020 5.6.3. Other label-information changes can be Category 3; the listed no-CN exceptions cover rephrasing/reordering IFU information, adding/removing languages not required by MDA, and distributor information that does not affect registered information. A new device name or registered identifier is assessed separately under the Category 2 row; a logo edit is not automatically exempt.

MDA announcement1799 makes GD0072 implementation conditional on the formal launch of MeDC@St3.0. The 14 October2026 re-registration guide still describes3.0 as under development, with a December2026 target and a further announcement before implementation. Use GD0020 for the recorded current CN answer unless a formal launch changes that condition. The automated2.0+ renewal route requires no active/pending CN or COO for the device.

GD0020 Table 2 5.6.4(c) assigns manufacturer registered-name or administrative-office-address changes, and manufacturing-site-name-only changes with no site-address change, to Category 3. These changes may be implemented after complete documents are submitted. A physical manufacturing-site move has a different Category 2 branch; it is not assumed for an office-only change.

GD0041 provides a registration-ownership application by the new AR after registration and after pending applications are completed or withdrawn. The effective transfer date is MDA approval, not the manufacturer appointment-letter date. Its current/new AR forms and unchanged manufacturer field do not establish unrestricted substitution of a different foreign legal manufacturer.

The Category 2 name/identifier row requires a declaration of conformity, a manufacturer declaration that the device is unchanged including intended use and technical specifications, updated configurations identifying affected devices, labels showing every amended section and annexes. The summary must state present/proposed information and reasons for all related changes.

The Category 3 manufacturer-information row calls for a declaration of conformity, the manufacturer undertaking to support devices already supplied under its former name where applicable, amended labels, an updated QMS certificate or relevant official evidence of the change, and annexes. The undertaking is post-market support evidence; it does not grant an unrestricted old-label sell-through period.

GD0041 requires Annex A signed by the new AR, its establishment licence, manufacturer LOA under GD0027 and a manufacturer request naming the devices and appointment date before submission. The current AR supplies Annex B, surrenders certificates and transfers distribution/complaints records. The guide gives approximately 30 working days from complete submission and RM 500 per registration ID; original certificate validity continues from its initial registration date.

The official CN fee table charges Category 2 RM 50/500/1000/1500 for Classes A/B/C/D respectively, or RM 2500 for a device containing a medicinal product; Category 3 is RM 30 across the merged class column. For a single ID with both categories, add the category fees; for multiple IDs multiply each applicable category fee by its ID count. The printed three-Class B-ID Category 2+3 example totals RM 1590.

GD0020 Table 5 lists30 working days for a single submission ID in Category 2 or3,60 working days for a single ID combining2+3, and60 working days for multiple IDs. These targets start with a complete application and supporting documents. Category 2 still requires endorsement before implementation; Category 3 may be implemented on complete submission rather than waiting for that administrative target.

GD0026 Seventh Edition requires device name/model and manufacturer information, plus the applicable local manufacturer/AR contact and IVD particulars. Labelling compliance may be completed after import or manufacture but before market placement; added AR/importer/translation labels must preserve the specified original traceability/date information. Changes to electronic labels follow GD0020, and corresponding paper IFUs must remain aligned.

The official FAQ permits any Category 2/3 changes for one medical device in one CN. Combining2-50 devices requires similar changes and is limited to the listed types, including specified facility/QMS/manufacturer-name or administrative-address changes. A pending CN for the same device must finish before another CN can be submitted. List every related change in Annex B; this permission does not combine an ownership transfer automatically.