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Indonesia medical device regulations

Official sources linked

Ministry of Health rules and guidance for medical device market access, registration, and lifecycle compliance. Each code opens a metadata page with the official source and readable HTML when available.

14 documents4 categories100% linked to official sourcesauthority Ministry of Health11 readable HTML
CodeRegulationCategoryEffectiveProvenance
Permenkes No.11/2025
Standards for Risk-Based Health Business and Product Licensing — Medical Device and IVD Provisions
Selected69 complete physical PDF pages: core articles1–40 and promulgation(pp1–23); device/IVD distributor and branch standards(pp253–263); domestic/import device standards(pp387–412); device distribution-practice certificates(pp443–451). Full540-page official PDF and full native extraction retained. Other health-service/drug/PKRT-specific annexes are not represented as device requirements. Art37 preserves specified pending applications; Art39 repeals PMK26/2018 and the corresponding PMK14/2021,8/2022,17/2024 business/product standards.
Registration2025-10-03Official
SE FR.03.01/E.V/2204/2026
Changes to IVD Categories, Subcategories, Product Types and Risk Classes
Complete six-page circular and annex. Issued16Oct2026; portal posting20Oct2026. Existing issued NIEs bearing earlier product nomenclature remain valid until expiry; nomenclature adjustments can use change or renewal-with-change applications. Annex tables are original layouts and require geometry-preserving figures.
Classification—Official
SE FR.03.01/E.V/1582/2026
Validation and Updating of KFA Reference Identifiers for Medical Devices
Complete two-page circular. Issued7Aug2026; portal posted10Sep2026. KFA reference-document URL validation and linkage to NIE/IDAK/CDB/CPB, with invalid entries returned to draft and excluded from e-catalog synchronization. KFA identifier is not assumed equivalent to a manufacturer SMN/REF.
Registration—Official
Exports carry source + retrieval date

Changes after registration in Indonesia

Source-linked rules for common changes to a registered IVD. Read the scope and conditions with each rule; unverified details are listed separately.

Does changing a device brand name or logo require an update?

A change to the registered brand name and a change to logo artwork can follow different rules. The legal manufacturer, device design and intended purpose remain the same.

Verified guidance on

Read each rule with its scope and conditions.

  • Filing route and prior approval

Imported-device technical-data changes

Fact-level verified

The technical annex to an imported-device permit records trade/brand name in relation to its written wording, type/size, packaging, producer/product owner, labelling, the accessory annex and other listed data. A technical-annex change is applied for through OSS and administratively/documentarily verified by the Ministry. Changes to business-operator/business-activity data follow the applicable legislation.

Conditions
  • Imported-device PB UMKU only.
  • Do not interpret correction of brand-name writing as blanket approval of a substantive brand or manufacturer replacement.
  • Apply the PMK11/2025 imported-device PB UMKU standard to its governing route; Article37 preserves specified pending/unverified/not-effective applications under the PMK14/2021 framework until the adjusted OSS system. Do not assume the same regime for every existing licence.

Conditions for this question

  • Only where the actual recorded technical-annex data changes; the existence of a manufacturer/product-owner field does not itself authorize replacement of the legal manufacturer or a production-site relocation.
  • Filing route and prior approval

Administrative changes affecting all manufacturer labelling

Fact-level verified

For administrative changes affecting labelling of all products of a manufacturer, the marketing-authorization holder must notify the Ministry of Health.

Conditions
  • This clause alone does not establish that every brand, manufacturer-name/address or ownership change qualifies as administrative.
  • Apply the PMK11/2025 imported-device PB UMKU standard to its governing route; Article37 preserves specified pending/unverified/not-effective applications under the PMK14/2021 framework until the adjusted OSS system. Do not assume the same regime for every existing licence.

Conditions for this question

  • Only an administrative change that affects labelling of all products of the producer is covered by this notification clause.
  • Filing route and prior approval

2021 guide: historical name, address, legal-entity and code examples

Fact-level verified

The 2021 guide Section2.4.8 lists principal name/address, manufacturer legal entity, manufacturer address without physical relocation, product-owner name/address without changing manufacturer name/address, producer name without address or NIB change, manufacturer name without address or product change, product codes/types and specified distributor identity changes as variation examples where safety, quality, performance and specification are unaffected. The producer-name and distributor-name/address cases in letters(i),(k),(l) require a prior manual company-database request. Section2.4.9 separately lists product-name changes, distributor replacement/transfer and manufacturer/production-location replacement among new applications.

Conditions
  • Guidance predates PMK11/2025 and PMK5/2026; current binding rules prevail and any conflicting details need explicit reconciliation.
  • Do not conflate non-relocation address edits or legal-entity-name changes with acquisition/new manufacturer identity.
  • This is an attributed historical-guide finding. Read its Section2.4.8 examples with DiagramG and Section2.4.9; current case classification under later binding legislation is not certified here.
  • Supporting documents
  • Free sale certificate impact

Documents for imported-device variations

Fact-level verified

A variation application includes the old licence and annex, new labelling, a no-change-to-safety/benefit/quality statement, applicable distributor/CDB or repackaging CPB documents, agency appointment legalized by an Indonesian government representative or Apostille, licence/CFS documents, safety-event statement or event report, English and Indonesian manual/package insert/IFU, applicable nuclear permit, accessory/variant/type-code list and evidence specific to the proposed technical change.

Conditions
  • Imported-device variation; apply conditional documents only to their stated trigger.
  • Apostille is an express alternative here; do not retain an exclusive embassy-legalization rule from superseded standards.
  • Apply the PMK11/2025 imported-device PB UMKU standard to its governing route; Article37 preserves specified pending/unverified/not-effective applications under the PMK14/2021 framework until the adjusted OSS system. Do not assume the same regime for every existing licence.
  • Change-specific review time

Published imported-device service windows

Fact-level verified

The imported-device standard lists maximum issuance windows: new class A 21, B 36, C 36 and D 55 working days; renewal 13 working days; variation and renewal-with-variation 16 working days. Notification-permit services have a separate 12-working-day window. Applicant corrections may be requested up to twice, each at most 10 working days, or 15 for class D. Hari means the working days prescribed by the central government.

Conditions
  • Published regulatory service windows, not empirical best/expected/worst predictions or a guaranteed all-in elapsed project duration.
  • Do not count preparation, prerequisite certificates or applicant corrections as automatically included or invent a start trigger not stated in the cited clause.
  • Apply the PMK11/2025 imported-device PB UMKU standard to its governing route; Article37 preserves specified pending/unverified/not-effective applications under the PMK14/2021 framework until the adjusted OSS system. Do not assume the same regime for every existing licence.
  • Use the actual eligible registration type and class. A company/holder transfer or substantive identity change is not automatically a 16-day variation. These are issuance service windows, not applicant submission deadlines or guaranteed total elapsed project duration.
  • Existing stock and transition

Stock depletion after labelling or agency transition

Fact-level verified

Old-label stock is given6months from approval of the new label; stock at the old distributor after an agency transition is given6months from issuance of the new authorization. Stock depletion requires Ministry approval of the operator application, and the application may be submitted only while the product authorization remains valid.

Conditions
  • Distinct from the separate import-to-domestic6month rule.
  • No automatic grace period without the stated approval.
  • Apply the PMK11/2025 imported-device PB UMKU standard to its governing route; Article37 preserves specified pending/unverified/not-effective applications under the PMK14/2021 framework until the adjusted OSS system. Do not assume the same regime for every existing licence.
  • Apply only to the actual approved labelling change or agency transition stated in Section5.g; a name, address or code edit does not by itself establish that this stock-depletion branch applies.
  • Labels and identifiers

Relabelling after permit or distributor identity changes

Fact-level verified

Relabelling/restickering is described for changes to the permit number and/or distributor name/address printed on packaging, and requires Ministry approval of the operator application.

Conditions
  • Does not establish an unrestricted right to relabel a foreign manufacturer identity change.
  • Apply the PMK11/2025 imported-device PB UMKU standard to its governing route; Article37 preserves specified pending/unverified/not-effective applications under the PMK14/2021 framework until the adjusted OSS system. Do not assume the same regime for every existing licence.
  • Only the changed permit number and/or distributor name/address on packaging triggers the cited branch; this is not unrestricted brand/foreign-manufacturer relabelling permission.
Change control →Label, IFU & language →UDI, listing & traceability →

How do I update a manufacturer's name without changing the legal entity?

The same legal manufacturer changes its name, potentially alongside the device brand. A transfer to another legal entity is a separate question; permission to combine filings needs its own evidence.

Verified guidance on

Read each rule with its scope and conditions.

  • Filing route and prior approval

Imported-device technical-data changes

Fact-level verified

The technical annex to an imported-device permit records trade/brand name in relation to its written wording, type/size, packaging, producer/product owner, labelling, the accessory annex and other listed data. A technical-annex change is applied for through OSS and administratively/documentarily verified by the Ministry. Changes to business-operator/business-activity data follow the applicable legislation.

Conditions
  • Imported-device PB UMKU only.
  • Do not interpret correction of brand-name writing as blanket approval of a substantive brand or manufacturer replacement.
  • Apply the PMK11/2025 imported-device PB UMKU standard to its governing route; Article37 preserves specified pending/unverified/not-effective applications under the PMK14/2021 framework until the adjusted OSS system. Do not assume the same regime for every existing licence.

Conditions for this question

  • Only where the actual recorded technical-annex data changes; the existence of a manufacturer/product-owner field does not itself authorize replacement of the legal manufacturer or a production-site relocation.
  • Filing route and prior approval

Administrative changes affecting all manufacturer labelling

Fact-level verified

For administrative changes affecting labelling of all products of a manufacturer, the marketing-authorization holder must notify the Ministry of Health.

Conditions
  • This clause alone does not establish that every brand, manufacturer-name/address or ownership change qualifies as administrative.
  • Apply the PMK11/2025 imported-device PB UMKU standard to its governing route; Article37 preserves specified pending/unverified/not-effective applications under the PMK14/2021 framework until the adjusted OSS system. Do not assume the same regime for every existing licence.

Conditions for this question

  • Only an administrative change that affects labelling of all products of the producer is covered by this notification clause.
  • Filing route and prior approval

2021 guide: historical name, address, legal-entity and code examples

Fact-level verified

The 2021 guide Section2.4.8 lists principal name/address, manufacturer legal entity, manufacturer address without physical relocation, product-owner name/address without changing manufacturer name/address, producer name without address or NIB change, manufacturer name without address or product change, product codes/types and specified distributor identity changes as variation examples where safety, quality, performance and specification are unaffected. The producer-name and distributor-name/address cases in letters(i),(k),(l) require a prior manual company-database request. Section2.4.9 separately lists product-name changes, distributor replacement/transfer and manufacturer/production-location replacement among new applications.

Conditions
  • Guidance predates PMK11/2025 and PMK5/2026; current binding rules prevail and any conflicting details need explicit reconciliation.
  • Do not conflate non-relocation address edits or legal-entity-name changes with acquisition/new manufacturer identity.
  • This is an attributed historical-guide finding. Read its Section2.4.8 examples with DiagramG and Section2.4.9; current case classification under later binding legislation is not certified here.
  • Supporting documents
  • Free sale certificate impact

Documents for imported-device variations

Fact-level verified

A variation application includes the old licence and annex, new labelling, a no-change-to-safety/benefit/quality statement, applicable distributor/CDB or repackaging CPB documents, agency appointment legalized by an Indonesian government representative or Apostille, licence/CFS documents, safety-event statement or event report, English and Indonesian manual/package insert/IFU, applicable nuclear permit, accessory/variant/type-code list and evidence specific to the proposed technical change.

Conditions
  • Imported-device variation; apply conditional documents only to their stated trigger.
  • Apostille is an express alternative here; do not retain an exclusive embassy-legalization rule from superseded standards.
  • Apply the PMK11/2025 imported-device PB UMKU standard to its governing route; Article37 preserves specified pending/unverified/not-effective applications under the PMK14/2021 framework until the adjusted OSS system. Do not assume the same regime for every existing licence.
  • Change-specific review time

Published imported-device service windows

Fact-level verified

The imported-device standard lists maximum issuance windows: new class A 21, B 36, C 36 and D 55 working days; renewal 13 working days; variation and renewal-with-variation 16 working days. Notification-permit services have a separate 12-working-day window. Applicant corrections may be requested up to twice, each at most 10 working days, or 15 for class D. Hari means the working days prescribed by the central government.

Conditions
  • Published regulatory service windows, not empirical best/expected/worst predictions or a guaranteed all-in elapsed project duration.
  • Do not count preparation, prerequisite certificates or applicant corrections as automatically included or invent a start trigger not stated in the cited clause.
  • Apply the PMK11/2025 imported-device PB UMKU standard to its governing route; Article37 preserves specified pending/unverified/not-effective applications under the PMK14/2021 framework until the adjusted OSS system. Do not assume the same regime for every existing licence.
  • Use the actual eligible registration type and class. A company/holder transfer or substantive identity change is not automatically a 16-day variation. These are issuance service windows, not applicant submission deadlines or guaranteed total elapsed project duration.
  • Existing stock and transition

Stock depletion after labelling or agency transition

Fact-level verified

Old-label stock is given6months from approval of the new label; stock at the old distributor after an agency transition is given6months from issuance of the new authorization. Stock depletion requires Ministry approval of the operator application, and the application may be submitted only while the product authorization remains valid.

Conditions
  • Distinct from the separate import-to-domestic6month rule.
  • No automatic grace period without the stated approval.
  • Apply the PMK11/2025 imported-device PB UMKU standard to its governing route; Article37 preserves specified pending/unverified/not-effective applications under the PMK14/2021 framework until the adjusted OSS system. Do not assume the same regime for every existing licence.
  • Apply only to the actual approved labelling change or agency transition stated in Section5.g; a name, address or code edit does not by itself establish that this stock-depletion branch applies.
Change control →Label, IFU & language →

What changes when the manufacturer's office address changes?

An office address change for the same legal entity, potentially alongside name and brand changes. This does not cover moving a factory or manufacturing site, and a combined filing cannot be assumed.

Verified guidance on

Read each rule with its scope and conditions.

  • Filing route and prior approval

Imported-device technical-data changes

Fact-level verified

The technical annex to an imported-device permit records trade/brand name in relation to its written wording, type/size, packaging, producer/product owner, labelling, the accessory annex and other listed data. A technical-annex change is applied for through OSS and administratively/documentarily verified by the Ministry. Changes to business-operator/business-activity data follow the applicable legislation.

Conditions
  • Imported-device PB UMKU only.
  • Do not interpret correction of brand-name writing as blanket approval of a substantive brand or manufacturer replacement.
  • Apply the PMK11/2025 imported-device PB UMKU standard to its governing route; Article37 preserves specified pending/unverified/not-effective applications under the PMK14/2021 framework until the adjusted OSS system. Do not assume the same regime for every existing licence.

Conditions for this question

  • Only where the actual recorded technical-annex data changes; the existence of a manufacturer/product-owner field does not itself authorize replacement of the legal manufacturer or a production-site relocation.
  • Filing route and prior approval

Administrative changes affecting all manufacturer labelling

Fact-level verified

For administrative changes affecting labelling of all products of a manufacturer, the marketing-authorization holder must notify the Ministry of Health.

Conditions
  • This clause alone does not establish that every brand, manufacturer-name/address or ownership change qualifies as administrative.
  • Apply the PMK11/2025 imported-device PB UMKU standard to its governing route; Article37 preserves specified pending/unverified/not-effective applications under the PMK14/2021 framework until the adjusted OSS system. Do not assume the same regime for every existing licence.

Conditions for this question

  • Only an administrative change that affects labelling of all products of the producer is covered by this notification clause.
  • Filing route and prior approval

2021 guide: historical name, address, legal-entity and code examples

Fact-level verified

The 2021 guide Section2.4.8 lists principal name/address, manufacturer legal entity, manufacturer address without physical relocation, product-owner name/address without changing manufacturer name/address, producer name without address or NIB change, manufacturer name without address or product change, product codes/types and specified distributor identity changes as variation examples where safety, quality, performance and specification are unaffected. The producer-name and distributor-name/address cases in letters(i),(k),(l) require a prior manual company-database request. Section2.4.9 separately lists product-name changes, distributor replacement/transfer and manufacturer/production-location replacement among new applications.

Conditions
  • Guidance predates PMK11/2025 and PMK5/2026; current binding rules prevail and any conflicting details need explicit reconciliation.
  • Do not conflate non-relocation address edits or legal-entity-name changes with acquisition/new manufacturer identity.
  • This is an attributed historical-guide finding. Read its Section2.4.8 examples with DiagramG and Section2.4.9; current case classification under later binding legislation is not certified here.
  • Supporting documents
  • Free sale certificate impact

Documents for imported-device variations

Fact-level verified

A variation application includes the old licence and annex, new labelling, a no-change-to-safety/benefit/quality statement, applicable distributor/CDB or repackaging CPB documents, agency appointment legalized by an Indonesian government representative or Apostille, licence/CFS documents, safety-event statement or event report, English and Indonesian manual/package insert/IFU, applicable nuclear permit, accessory/variant/type-code list and evidence specific to the proposed technical change.

Conditions
  • Imported-device variation; apply conditional documents only to their stated trigger.
  • Apostille is an express alternative here; do not retain an exclusive embassy-legalization rule from superseded standards.
  • Apply the PMK11/2025 imported-device PB UMKU standard to its governing route; Article37 preserves specified pending/unverified/not-effective applications under the PMK14/2021 framework until the adjusted OSS system. Do not assume the same regime for every existing licence.
  • Change-specific review time

Published imported-device service windows

Fact-level verified

The imported-device standard lists maximum issuance windows: new class A 21, B 36, C 36 and D 55 working days; renewal 13 working days; variation and renewal-with-variation 16 working days. Notification-permit services have a separate 12-working-day window. Applicant corrections may be requested up to twice, each at most 10 working days, or 15 for class D. Hari means the working days prescribed by the central government.

Conditions
  • Published regulatory service windows, not empirical best/expected/worst predictions or a guaranteed all-in elapsed project duration.
  • Do not count preparation, prerequisite certificates or applicant corrections as automatically included or invent a start trigger not stated in the cited clause.
  • Apply the PMK11/2025 imported-device PB UMKU standard to its governing route; Article37 preserves specified pending/unverified/not-effective applications under the PMK14/2021 framework until the adjusted OSS system. Do not assume the same regime for every existing licence.
  • Use the actual eligible registration type and class. A company/holder transfer or substantive identity change is not automatically a 16-day variation. These are issuance service windows, not applicant submission deadlines or guaranteed total elapsed project duration.
  • Existing stock and transition

Stock depletion after labelling or agency transition

Fact-level verified

Old-label stock is given6months from approval of the new label; stock at the old distributor after an agency transition is given6months from issuance of the new authorization. Stock depletion requires Ministry approval of the operator application, and the application may be submitted only while the product authorization remains valid.

Conditions
  • Distinct from the separate import-to-domestic6month rule.
  • No automatic grace period without the stated approval.
  • Apply the PMK11/2025 imported-device PB UMKU standard to its governing route; Article37 preserves specified pending/unverified/not-effective applications under the PMK14/2021 framework until the adjusted OSS system. Do not assume the same regime for every existing licence.
  • Apply only to the actual approved labelling change or agency transition stated in Section5.g; a name, address or code edit does not by itself establish that this stock-depletion branch applies.
Change control →Label, IFU & language →

Does a catalogue or reference code change affect registration or UDI?

Check which identifier actually changes. A commercial catalogue, REF or order code is not automatically a device model, registered identifier, GTIN or UDI-DI. Rules for one identifier do not establish the route for another.

Verified guidance on

Read each rule with its scope and conditions.

  • Filing route and prior approval

Imported-device technical-data changes

Fact-level verified

The technical annex to an imported-device permit records trade/brand name in relation to its written wording, type/size, packaging, producer/product owner, labelling, the accessory annex and other listed data. A technical-annex change is applied for through OSS and administratively/documentarily verified by the Ministry. Changes to business-operator/business-activity data follow the applicable legislation.

Conditions
  • Imported-device PB UMKU only.
  • Do not interpret correction of brand-name writing as blanket approval of a substantive brand or manufacturer replacement.
  • Apply the PMK11/2025 imported-device PB UMKU standard to its governing route; Article37 preserves specified pending/unverified/not-effective applications under the PMK14/2021 framework until the adjusted OSS system. Do not assume the same regime for every existing licence.

Conditions for this question

  • Only where the actual recorded technical-annex data changes; the existence of a manufacturer/product-owner field does not itself authorize replacement of the legal manufacturer or a production-site relocation.
  • Filing route and prior approval

Administrative changes affecting all manufacturer labelling

Fact-level verified

For administrative changes affecting labelling of all products of a manufacturer, the marketing-authorization holder must notify the Ministry of Health.

Conditions
  • This clause alone does not establish that every brand, manufacturer-name/address or ownership change qualifies as administrative.
  • Apply the PMK11/2025 imported-device PB UMKU standard to its governing route; Article37 preserves specified pending/unverified/not-effective applications under the PMK14/2021 framework until the adjusted OSS system. Do not assume the same regime for every existing licence.

Conditions for this question

  • Only an administrative change that affects labelling of all products of the producer is covered by this notification clause.
  • Filing route and prior approval

2021 guide: historical name, address, legal-entity and code examples

Fact-level verified

The 2021 guide Section2.4.8 lists principal name/address, manufacturer legal entity, manufacturer address without physical relocation, product-owner name/address without changing manufacturer name/address, producer name without address or NIB change, manufacturer name without address or product change, product codes/types and specified distributor identity changes as variation examples where safety, quality, performance and specification are unaffected. The producer-name and distributor-name/address cases in letters(i),(k),(l) require a prior manual company-database request. Section2.4.9 separately lists product-name changes, distributor replacement/transfer and manufacturer/production-location replacement among new applications.

Conditions
  • Guidance predates PMK11/2025 and PMK5/2026; current binding rules prevail and any conflicting details need explicit reconciliation.
  • Do not conflate non-relocation address edits or legal-entity-name changes with acquisition/new manufacturer identity.
  • This is an attributed historical-guide finding. Read its Section2.4.8 examples with DiagramG and Section2.4.9; current case classification under later binding legislation is not certified here.
  • Filing route and prior approval
  • Labels and identifiers

New IVD nomenclature and existing permits

Fact-level verified

CircularFR.03.01/E.V/2204/2026 changes IVD category/subcategory/product-type/risk-class nomenclature per its annex. Already issued valid NIEs with the former nomenclature remain valid until expiry; holders may seek nomenclature adjustment through variation or renewal-with-variation.

Conditions
  • Source issued16October2026; portal posted20October2026.
  • Apply actual listed IVD product rows; do not infer that all IVD classes changed or that old approvals were invalidated.
  • Authority IVD nomenclature/classification adjustment only; not a rule classifying a commercial SMN/REF change or a substantive model/design change.
  • Supporting documents
  • Free sale certificate impact

Documents for imported-device variations

Fact-level verified

A variation application includes the old licence and annex, new labelling, a no-change-to-safety/benefit/quality statement, applicable distributor/CDB or repackaging CPB documents, agency appointment legalized by an Indonesian government representative or Apostille, licence/CFS documents, safety-event statement or event report, English and Indonesian manual/package insert/IFU, applicable nuclear permit, accessory/variant/type-code list and evidence specific to the proposed technical change.

Conditions
  • Imported-device variation; apply conditional documents only to their stated trigger.
  • Apostille is an express alternative here; do not retain an exclusive embassy-legalization rule from superseded standards.
  • Apply the PMK11/2025 imported-device PB UMKU standard to its governing route; Article37 preserves specified pending/unverified/not-effective applications under the PMK14/2021 framework until the adjusted OSS system. Do not assume the same regime for every existing licence.
  • Change-specific review time

Published imported-device service windows

Fact-level verified

The imported-device standard lists maximum issuance windows: new class A 21, B 36, C 36 and D 55 working days; renewal 13 working days; variation and renewal-with-variation 16 working days. Notification-permit services have a separate 12-working-day window. Applicant corrections may be requested up to twice, each at most 10 working days, or 15 for class D. Hari means the working days prescribed by the central government.

Conditions
  • Published regulatory service windows, not empirical best/expected/worst predictions or a guaranteed all-in elapsed project duration.
  • Do not count preparation, prerequisite certificates or applicant corrections as automatically included or invent a start trigger not stated in the cited clause.
  • Apply the PMK11/2025 imported-device PB UMKU standard to its governing route; Article37 preserves specified pending/unverified/not-effective applications under the PMK14/2021 framework until the adjusted OSS system. Do not assume the same regime for every existing licence.
  • Use the actual eligible registration type and class. A company/holder transfer or substantive identity change is not automatically a 16-day variation. These are issuance service windows, not applicant submission deadlines or guaranteed total elapsed project duration.
  • Existing stock and transition

Stock depletion after labelling or agency transition

Fact-level verified

Old-label stock is given6months from approval of the new label; stock at the old distributor after an agency transition is given6months from issuance of the new authorization. Stock depletion requires Ministry approval of the operator application, and the application may be submitted only while the product authorization remains valid.

Conditions
  • Distinct from the separate import-to-domestic6month rule.
  • No automatic grace period without the stated approval.
  • Apply the PMK11/2025 imported-device PB UMKU standard to its governing route; Article37 preserves specified pending/unverified/not-effective applications under the PMK14/2021 framework until the adjusted OSS system. Do not assume the same regime for every existing licence.
  • Apply only to the actual approved labelling change or agency transition stated in Section5.g; a name, address or code edit does not by itself establish that this stock-depletion branch applies.
Change control →UDI, listing & traceability →Label, IFU & language →

Can several changes be filed together?

Changes to brand, manufacturer name, office address and reference codes may occur together, including with a real transfer to another legal manufacturer, registration holder or owner. Assess transfer with each single change, and transfer with brand plus reference, manufacturer name plus reference, or office address plus reference changes: seven transfer combinations in total. Evidence must establish the exact combination and the order of filings and approvals. These combinations and their sequence are not all verified by the rules below; a rule for one change does not prove that a single application, fee or review period covers the combination.

Verified guidance on

Read each rule with its scope and conditions.

  • Combined filing
  • Filing route and prior approval

2021 guide: historical simultaneous-change submission rule

Fact-level verified

The2021 guide says each simultaneous change is assessed separately, the changes may be submitted together with an explanation of the differences, and the registration type follows the highest route triggered by the changes. Its example combines a sterilization change(new application), package-layout variation and manufacturer-logo notification into one new application.

Conditions
  • One product with multiple changes; not blanket grouping across unrelated licences.
  • Legacy guide: verify compatibility with the current PMK11/2025 and PMK5/2026 framework.
  • The source describes the historical guide itself; current compatibility with later binding rules must be checked before relying on it as a current filing permission.
  • Supporting documents
  • Free sale certificate impact

Documents for imported-device variations

Fact-level verified

A variation application includes the old licence and annex, new labelling, a no-change-to-safety/benefit/quality statement, applicable distributor/CDB or repackaging CPB documents, agency appointment legalized by an Indonesian government representative or Apostille, licence/CFS documents, safety-event statement or event report, English and Indonesian manual/package insert/IFU, applicable nuclear permit, accessory/variant/type-code list and evidence specific to the proposed technical change.

Conditions
  • Imported-device variation; apply conditional documents only to their stated trigger.
  • Apostille is an express alternative here; do not retain an exclusive embassy-legalization rule from superseded standards.
  • Apply the PMK11/2025 imported-device PB UMKU standard to its governing route; Article37 preserves specified pending/unverified/not-effective applications under the PMK14/2021 framework until the adjusted OSS system. Do not assume the same regime for every existing licence.
  • Change-specific review time

Published imported-device service windows

Fact-level verified

The imported-device standard lists maximum issuance windows: new class A 21, B 36, C 36 and D 55 working days; renewal 13 working days; variation and renewal-with-variation 16 working days. Notification-permit services have a separate 12-working-day window. Applicant corrections may be requested up to twice, each at most 10 working days, or 15 for class D. Hari means the working days prescribed by the central government.

Conditions
  • Published regulatory service windows, not empirical best/expected/worst predictions or a guaranteed all-in elapsed project duration.
  • Do not count preparation, prerequisite certificates or applicant corrections as automatically included or invent a start trigger not stated in the cited clause.
  • Apply the PMK11/2025 imported-device PB UMKU standard to its governing route; Article37 preserves specified pending/unverified/not-effective applications under the PMK14/2021 framework until the adjusted OSS system. Do not assume the same regime for every existing licence.
  • Use the actual eligible registration type and class. A company/holder transfer or substantive identity change is not automatically a 16-day variation. These are issuance service windows, not applicant submission deadlines or guaranteed total elapsed project duration.
  • Existing stock and transition

Stock depletion after labelling or agency transition

Fact-level verified

Old-label stock is given6months from approval of the new label; stock at the old distributor after an agency transition is given6months from issuance of the new authorization. Stock depletion requires Ministry approval of the operator application, and the application may be submitted only while the product authorization remains valid.

Conditions
  • Distinct from the separate import-to-domestic6month rule.
  • No automatic grace period without the stated approval.
  • Apply the PMK11/2025 imported-device PB UMKU standard to its governing route; Article37 preserves specified pending/unverified/not-effective applications under the PMK14/2021 framework until the adjusted OSS system. Do not assume the same regime for every existing licence.
  • Apply only to the actual approved labelling change or agency transition stated in Section5.g; a name, address or code edit does not by itself establish that this stock-depletion branch applies.
Change control →Dossier requirements →
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Tracked from official Ministry of Health publications · row IDs are stable — cite as regulations:indonesia:id-cdakb