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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. 5/2026
Regulation of Minister of Health No. 5/2026 on Health Supplies (Perbekalan Kesehatan)
Permenkes No. 5 Tahun 2026 tentang Perbekalan Kesehatan — the current Kemenkes instrument for pharmaceuticals and medical devices, promulgated in Berita Negara 2026 No. 283 (established 17 April 2026, promulgated 4 May 2026, 52 pages). Implements PP 28/2024 and repeals PMK 62/2017, moving distribution permits (izin edar) into the perbekalan kesehatan regime; its transitional articles (BAB IX, Pasal 122–125) keep specified PMK 62/2017 provisions in force pro tempore. Ingested Bab I–X, Pasal 1–126, and the pengundangan block from the official Ministry JDIH PDF.
General4 May 2026Official
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
PP No. 42/2024
Government Regulation No. 42/2024 on the Implementation of the Halal Product Assurance Sector
PP No. 42 Tahun 2024 tentang Penyelenggaraan Bidang Jaminan Produk Halal — the controlling halal instrument for medical devices, implementing UU 33/2014 (as amended by UU 6/2023 Cipta Kerja) and repealing PP 39/2021 (Lembaran Negara 2024 No. 229, TLN No. 6998; established and promulgated 17 October 2024). Pasal 161(1)(g)–(i) phase the certification obligation for alat kesehatan by risk class: kelas A by 17 October 2026, kelas B by 17 October 2029, kelas C by 17 October 2034 (no separate kelas D deadline appears); Pasal 126 assigns the BPJPH–Kemenkes cooperation scope for alat kesehatan and perbekalan kesehatan rumah tangga; Pasal 162 lets obat/biologi/alkes with non-halal starting materials circulate with origin labelling pending a further Peraturan Presiden. Ingested Bab I–XVII, Pasal 1–198, the pengundangan block, and the Penjelasan from the official salinan scan mirrored on the Kemenkoinfra JDIH (the scan's OCR layer carries disclosed digit/header artefacts; the deadline years in Pasal 161 are digit-clean).
General17 October 2024Official
CDAKB Certification
Good Distribution Practice for Medical Devices (CDAKB) Portal
Official CDAKB certification portal. Effective July 1, 2024, CDAKB certificate is mandatory for distributors to register new medical products. MOH audits distributor facilities.
GMP/QMSJuly 2024Official
Farmalkes Portal
Pharmaceutical and Medical Device Information System
Comprehensive information system for pharmaceutical and medical device regulations, including registration requirements and regulatory updates.
Registration2022Official
Evaluation Guidelines 2020
Guidelines for Evaluation of Medical Devices and In Vitro Diagnostics
Official 2020 bilingual evaluation guideline (ISBN 978-623-301-025-2, 226 pages; Indonesian authoritative with English translations) issued by the Directorate of Medical Device Evaluation under Permenkes 62/2017: legal basis, definitions, and the full registration procedure — User ID/password application, new product-license applications (evaluation requirements by risk class), renewals, variations, renewal-with-variation, technical development and consultation — plus Lampiran 1-10 (requirement matrices by application type, document lists, forms, contacts, evaluation flows, and the application flowchart). Ingested BAB I-III with all numbered subsections and the ten annexes. Still served as the evaluation guidance on the official Regalkes portal; note its parent instrument PMK 62/2017 is marked repealed by Permenkes 5/2026 on the Ministry JDIH (see EXP-21 for the current legal family).
Registration2020Official
Regalkes Portal
Medical Device Registration Portal (Regalkes)
Official online portal for medical device registration, distribution permits, and regulatory submissions to Indonesia Ministry of Health.
Registration2020Official
PMK No. 62/2017
Regulation of Minister of Health No. 62/2017 on Medical Device Distribution Permits
Historical PMK No. 62 Tahun 2017 on distribution permits (izin edar) for medical devices, IVDs, and household health supplies. Ingested Bab I–XIII, Pasal 1–68, and Lampiran I–II from the official Regalkes PDF. Established 29 December 2017 and promulgated 12 January 2018 (Berita Negara 2018 No. 82). Superseded by Permenkes No. 5 Tahun 2026 (id-permenkes-5-2026), whose transitional articles keep specified PMK 62/2017 provisions in force pro tempore.
General12 January 2018Official
Pedoman Klasifikasi
Pedoman Klasifikasi Alat Kesehatan (AMDD-Harmonized Classification Guide)
Ditjen Kefarmasian dan Alat Kesehatan classification guide (September 2016), the original Indonesian authority expression of the AMDD-harmonized rules: Ketentuan 1-22 for medical devices (sec-3-1) and PERATURAN 1-7 for IVD (sec-3-2), classes A-D. Replaces the former AHWP third-party copy (ahwp.info unreachable). The statutory classes are now Permenkes 5/2026 Pasal 55; this pedoman remains the rule-level detail. Exact official PDF ingested as sec-1 through sec-4 plus Annexes 1-3.
Classification—Official
Guideline Penentuan Kelas
Official Product-Type Classification Catalogue
Official Regalkes Guideline Penentuan Kelas table: 2,943 authority-published product-type rows with device/IVD context, category, subcategory, product name, optional HS code, numeric class, and ASEAN risk class. This is product-level classification evidence; id-classification remains the rule-level source.
Classification—Official
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
PP No. 64 Tahun 2019
PP 64/2019 — Ministry of Health non-tax revenue fee framework, complete body and explanation
Complete 12-page official BPK-hosted body and explanation of PP 64/2019, preserved with all original images and its unchanged, potentially degraded native search layer. The separate 241-page fee annex is archived independently; this body alone does not reproduce its fee tables. Broad Ministry of Health and non-device provisions are retained as statutory context, not expanded to medical devices or IVDs. No 2026 fee, relief, review-clock, risk-class mapping or change-question completion is asserted. Current consolidated applicability remains unverified.
Registration—Official
PP 64/2019 — selected medical-device fee annex pages
PP 64/2019 fee annex — medical-device licensing, changes, renewal and certificate pages
Six selected complete physical pages from the full 241-page official BPK-hosted annex: identity/cover page 1 and pages 160–164, which contain medical-device licensing and certificates, distribution-permit changes, device marketing-permit issue/renewal/change/renewal-with-change rows, and production certificates. Full original PDF and full native extraction remain archived. Whole source page context includes neighboring pharmaceutical and PKRT rows; those are not device requirements. Original printed marketing-permit classes I–III and production-certificate classes A–C are preserved separately and are not mapped to current risk classes A–D. Page images govern damaged original OCR; no correction or current 2026 fee/IVD applicability/question completion is asserted. This is not the whole annex or a separate new law from its companion body.
Registration—Official
Exports carry source + retrieval date

Changes after registration in Indonesia

Source-linked rules for common changes to a registered medical device. 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

Change-control outcomes

Fact-level verified

An izin edar change (perubahan) is available for changes of: size; packaging; labelling; accessories/annexes to the authorization; and name/address of the representative empowered by the manufacturer - processed without changing the izin edar number. OSS standards additionally provide variation services for changes of technical responsible person, product type and premises layout.

Conditions
  • All classes.
  • Data changes beyond the enumerated list require a new application.

Effective from 2018-01-12

Confirms baseline fact. Continues pro tempore per PMK 5/2026 Pasal 124; PMK 14/2021 product standards offer perubahan and perpanjangan-dengan-perubahan services per class.

  • 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 →Economic-operator roles →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 →Economic-operator roles →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.
  • 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 →Official forms & portals →Dossier requirements →
Regulation codes

What these codes are

Each row above represents one regulatory instrument. Its code is the authority’s identifier. A regulation page collects the metadata and official source; when readable HTML is available, article links can open and highlight the exact cited passage.

Use this market context

Continue from regulations into practical research

Keep Indonesia as the target market while you move into registration records, classification, cross-country product research, or pathway planning.

Classify a device for Indonesia

Check a preliminary Ministry of Health risk class.

Search registered products

Inspect public Ministry of Health records.

Compare products across markets

Search the same product in multiple country registries.

Build a registration plan

Estimate pathway, government fees, preparation, and review time.

Build a reusable product master

Structure company, product, model, approval, and evidence facts once.

Map dossier reuse and deltas

Compare existing evidence against Indonesia needs.

Build a market-launch workpaper

Connect route, evidence, labels, representatives, and launch dependencies.

Assess a regulatory change

Test a current Ministry of Health update against one product and its evidence.

Keep researching this market

More Indonesia medical device resources

View the Indonesia resource hub →
Compare regulations across all countries →
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Tracked from official Ministry of Health publications · row IDs are stable — cite as regulations:indonesia:id-cdakb