Ministry of Health · structured requirements

🇮🇩 Indonesia IVD regulatory data

Explore the IVD requirements currently available for Indonesia, organized by topic and linked to official sources.

12 facts7 dimensions5 official sourceslatest verification 2026-10-26

Changes after registration

Common questions about changing a registered IVD in Indonesia. Each question separates published rules from details still awaiting verification.

Does changing a device brand name or logo require an update? →Source-linked rules available
How do I update a manufacturer's name without changing the legal entity? →Source-linked rules available
What changes when the manufacturer's office address changes? →Source-linked rules available
Does a catalogue or reference code change affect registration or UDI? →Source-linked rules available
Can a registration transfer to a different legal entity? →Source-linked rules available
Can several changes be filed together? →Source-linked rules available

Change control

Does the event require internal documentation, notice, prior approval, transfer, or a new application?

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Administrative changes affecting all manufacturer labelling

change.all-product-administrative-notification-2025

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.

2021 guide: historical simultaneous-change submission rule

change.combination-highest-route-guide2021

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.

New IVD nomenclature and existing permits

change.ivd-nomenclature-circular2026

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.

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

change.name-address-code-guide2021

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.

Stock depletion after labelling or agency transition

change.stock-depletion-2025

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.

Imported-device technical-data changes

change.technical-data-2025

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.

Dossier requirements

Which evidence, local deltas, formats, and signatures are required?

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Documents for imported-device variations

change.dossier-2025

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.

Label, IFU & language

Which label and IFU elements, languages, symbols, and translation controls apply?

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Relabelling after permit or distributor identity changes

change.restickering-2025

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.

Registration pathways

Which registration, notification, listing, reliance, or conformity route applies?

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Possibility of product grouping

change.grouping-2025

Fact-level verified

Some medical-device products can be registered in one product package/grouping.

Conditions

Grouping eligibility is product-specific; this clause does not permit consolidation of arbitrary independent licences.
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.

Reliance & recognition

Which foreign decisions or evidence can be reused, with what effect and conditions?

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Existing records include acceptance, restrictions and evidence reuse. The applicable product scope and conditions are preserved below; a reference does not by itself confer market access.

Indonesia approvals and evidence in other markets (0 records)

No linked record is currently maintained. This does not establish that a pathway is unavailable.

Prior approvals and evidence for Indonesia (8 records)

IndonesiaNMPA

Regulatory reference

Indonesia import permit required; NMPA reliance eligibility not resolved by this clause

reliance.china-nmpa-no-recognition-route

Pending verification

Statement: PMK 5/2026 Pasal 58(4) requires the Indonesian izin edar before importing medical devices and PKRT, subject to the applicable exceptions. This establishes a local permit requirement. It does not determine whether reliance, evidence reuse or an abridged assessment may be available in obtaining that permit; the cited clause alone cannot support a country-wide finding that NMPA evidence has no benefit.
Source Jurisdiction Id: china
Source Authority Id: nmpa
Source Approval: China NMPA medical device registration certificate (Class II/III) or Class I filing record
Target Jurisdiction Id: indonesia
China Classes In Scope: Medical devices and PKRT within Pasal 58; local classification and application pathway require separate assessment
Edge Type: Eligibility Unresolved
Market Access Strength: undetermined
Regulatory Layer: Product Marketing
Local Application Required: Yes
Target Decision Retained: Yes

Conditions

Pasal 58(5) allows an import certificate in specified circumstances; Pasal 62 addresses special access.
Do not infer absence of reliance from a local permit requirement.
Independent verification is incomplete. Treat this record as a research lead, not a confirmed benefit or exclusion; see the 2026-09-15 independent review.

Effective from 2026-05-04

Independent review of PMK 5/2026, Pasal 58(4)-(5) and 62, from the Ministry JDIH PDF; source-backed-partial reflects unresolved NMPA pathway eligibility.

IndonesiaEU conformity assessment

Prior approval / evidence record

EU CE Mark

Authority: EU CE Mark
Accepted: Yes
Benefit: Supports the Certificate of Free Sale and the technical evidence in the CSDT, but Kemenkes publishes no shorter period for it
Timeline Savings: None published

Kemkes Regalkes — evaluation guideline Annex 8 service-standard clocks ACCSQ Medical Device Product Working Group — Implementing the ASEAN Medical Device Directive: "Not intended to confer mutual recognition; each member state retains sovereign right for registration decisions"

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

IndonesiaUS FDA

Prior approval / evidence record

FDA 510(k)

Authority: FDA 510(k)
Accepted: Yes
Benefit: Supports the Certificate of Free Sale and the technical evidence in the CSDT, but Kemenkes publishes no shorter period for it
Timeline Savings: None published

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

IndonesiaUS FDA · EU conformity assessment · ASEAN

Prior approval / evidence record

Class C

class-c

Class Name

Class C

Risk Level

high

Pathway

Full Registration

Official Timeline

Min: 30
Max: 30
Unit: working-days

Verification Status

official-verified

Official Source

Title: Kemkes Regalkes — evaluation guideline Annex 8 service-standard clocks
Url: https://regalkes.kemkes.go.id/informasi_alkes/Indonesia%20Guideline%20for%20Evaluation%20of%20Medical%20Device%20and%20IVD%202020.pdf
Accessed Date: 2026-08-25

Realistic Timeline

Min: 4
Max: 6
Unit: months

Prior Approval Benefits

ASEAN MRA countries
FDA
EU CE Mark

Notes

Official service-standard clock for imported Class C izin edar (new application): 30 working days of evaluation (Annex 8)
Clinical data may be required

Clinical Trial Required

Local Testing Required

Yes

Gmp Required

Yes

Kemkes Regalkes — evaluation guideline Annex 8 service-standard clocks

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

IndonesiaASEAN

Prior approval / evidence record

ASEAN member-state registration

Authority: ASEAN member-state registration
Accepted: No
Benefit: There is no ASEAN mutual recognition agreement for device registration — the AMDD harmonises the dossier, not the decision
Timeline Savings: None

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

IndonesiaASEAN

Prior approval / evidence record

ASEAN Medical Device Directive (AMDD) harmonisation

Name: ASEAN Medical Device Directive (AMDD) harmonisation
Description: The AMDD gives the ten member states one device definition, one set of classification rules, one set of essential principles and one dossier structure, the Common Submission Dossier Template. It is not a reliance route. The ACCSQ Medical Device Product Working Group states in terms that the Directive is "not intended to confer mutual recognition" and that each member state retains the sovereign right to make its own registration decisions, so a registration in one ASEAN market authorises nothing in another and shortens no national review period.
Timeline Reduction: None — the saving is in dossier preparation, since one CSDT core can be reused across member states with national addenda
Eligibility: Any device filed in an ASEAN member state that has transposed the AMDD into national law

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

IndonesiaUS FDA · EU conformity assessment · ASEAN

Prior approval / evidence record

Class D

class-d

Class Name

Class D

Risk Level

highest

Pathway

Full Registration

Official Timeline

Min: 45
Max: 45
Unit: working-days

Verification Status

official-verified

Official Source

Title: Kemkes Regalkes — evaluation guideline Annex 8 service-standard clocks
Url: https://regalkes.kemkes.go.id/informasi_alkes/Indonesia%20Guideline%20for%20Evaluation%20of%20Medical%20Device%20and%20IVD%202020.pdf
Accessed Date: 2026-08-25

Realistic Timeline

Min: 5
Max: 7
Unit: months

Prior Approval Benefits

ASEAN MRA countries
FDA
EU CE Mark

Notes

Official service-standard clock for imported Class D izin edar (new application): 45 working days of evaluation (Annex 8)
Clinical evidence required

Clinical Trial Required

Yes

Local Testing Required

Yes

Gmp Required

Yes

Kemkes Regalkes — evaluation guideline Annex 8 service-standard clocks

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

IndonesiaUS FDA · EU conformity assessment · ASEAN

Prior approval / evidence record

Class B

class-b

Class Name

Class B

Risk Level

medium

Pathway

Registration

Official Timeline

Min: 30
Max: 30
Unit: working-days

Verification Status

official-verified

Official Source

Title: Kemkes Regalkes — evaluation guideline Annex 8 service-standard clocks
Url: https://regalkes.kemkes.go.id/informasi_alkes/Indonesia%20Guideline%20for%20Evaluation%20of%20Medical%20Device%20and%20IVD%202020.pdf
Accessed Date: 2026-08-25

Realistic Timeline

Min: 4
Max: 6
Unit: months

Prior Approval Benefits

ASEAN MRA countries
FDA
EU CE Mark

Notes

Official service-standard clock for imported Class B izin edar (new application): 30 working days of evaluation (Annex 8)
ASEAN harmonization applies

Clinical Trial Required

Local Testing Required

Yes

Gmp Required

Yes

Kemkes Regalkes — evaluation guideline Annex 8 service-standard clocks

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

Review clocks

What review, validation, and applicant stop-clock rules apply?

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Published imported-device service windows

change.service-times-2025

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.

UDI, listing & traceability

Which UDI, device listing, database, and traceability duties apply?

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KFA reference-identifier document linkage

change.kfa-reference-identifiers2026

Fact-level verified

CircularFR.03.01/E.V/1582/2026 requires NIE holders to validate KFA reference URLs to licensing documents, including NIE and applicable IDAK/CDB/CPB, using OSS-RBA downloaded PDFs. Invalid or inaccessible links require obtaining the correct documents. Failure can return valid KFA codes to draft and prevent synchronization to the sector e-catalog.

Conditions

KFA document-reference validation, not proof that manufacturer SMN/REF changes are themselves exempt or that KFA equals a commercial product code.

Related structured datasets

Classification systems · 1 record

Open Risk classes A through D. →

indonesia:medical-device

Jurisdiction Id

indonesia

Domains

medical-device
ivd

Name

Risk classes A through D.

Classes

Id
a
Label
Class A
Normalized Risk Level
low
Id
b
Label
Class B
Normalized Risk Level
medium
Id
c
Label
Class C
Normalized Risk Level
high
Id
d
Label
Class D
Normalized Risk Level
highest

Regulator

Ministry of Health

Official Domains

kemkes.go.id

Source Status

official-source-verified

Source Title

Peraturan Menteri Kesehatan No. 5 Tahun 2026, Pasal 55 (klasifikasi perbekalan kesehatan)

Source Url

https://farmalkes.kemkes.go.id/unduh/peraturan-menteri-kesehatan-nomor-5-tahun-2026-tentang-perbekalan-kesehatan/

Verified On

2026-08-25

Source Supports

class-axis

Notes

PMK 5/2026 Pasal 55 (previously PMK 62/2017): class A low risk, B low-to-moderate, C moderate-to-high, D high risk; additionally classified by intended use into categories and subcategories per ministerial technical guideline.
PMK 14/2021 product standards: IVD classes A-D by risk to individual/public (A low/low; B moderate/low; C high/moderate; D high/high); a 'class A tertentu' subset (home-use, no special skill, non-sterile, non-IVD) is eligible for notification.

Registration pathways, prior approvals and planning · 1 record

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open Indonesia registration →

Country

Indonesia

Jurisdiction Id

indonesia

Country Code

Flag

🇮🇩

Regulator

Ministry of Health

Regulator Abbrev

Ministry of Health

Region

asia-pacific

Tier

Risk Classification

4-class (A, B, C, D)

Classes

Id
class-a
Class Name
Class A
Risk Level
low
Pathway
Notification
Official Timeline
Min
15
Max
15
Unit
working-days
Verification Status
official-verified
Official Source
Title
Kemkes Regalkes — evaluation guideline Annex 8 service-standard clocks
Url
https://regalkes.kemkes.go.id/informasi_alkes/Indonesia%20Guideline%20for%20Evaluation%20of%20Medical%20Device%20and%20IVD%202020.pdf
Accessed Date
2026-08-25
Realistic Timeline
Min
2
Max
4
Unit
months
Notes
Official service-standard clock for imported Class A izin edar (new application): 15 working days of evaluation (evaluation guideline Annex 8)
Simplified notification
Clinical Trial Required
No
Local Testing Required
No
Gmp Required
No
Id
class-b
Class Name
Class B
Risk Level
medium
Pathway
Registration
Official Timeline
Min
30
Max
30
Unit
working-days
Verification Status
official-verified
Official Source
Title
Kemkes Regalkes — evaluation guideline Annex 8 service-standard clocks
Url
https://regalkes.kemkes.go.id/informasi_alkes/Indonesia%20Guideline%20for%20Evaluation%20of%20Medical%20Device%20and%20IVD%202020.pdf
Accessed Date
2026-08-25
Realistic Timeline
Min
4
Max
6
Unit
months
Prior Approval Benefits
ASEAN MRA countries
FDA
EU CE Mark
Notes
Official service-standard clock for imported Class B izin edar (new application): 30 working days of evaluation (Annex 8)
ASEAN harmonization applies
Clinical Trial Required
No
Local Testing Required
Yes
Gmp Required
Yes
Id
class-c
Class Name
Class C
Risk Level
high
Pathway
Full Registration
Official Timeline
Min
30
Max
30
Unit
working-days
Verification Status
official-verified
Official Source
Title
Kemkes Regalkes — evaluation guideline Annex 8 service-standard clocks
Url
https://regalkes.kemkes.go.id/informasi_alkes/Indonesia%20Guideline%20for%20Evaluation%20of%20Medical%20Device%20and%20IVD%202020.pdf
Accessed Date
2026-08-25
Realistic Timeline
Min
4
Max
6
Unit
months
Prior Approval Benefits
ASEAN MRA countries
FDA
EU CE Mark
Notes
Official service-standard clock for imported Class C izin edar (new application): 30 working days of evaluation (Annex 8)
Clinical data may be required
Clinical Trial Required
No
Local Testing Required
Yes
Gmp Required
Yes
Id
class-d
Class Name
Class D
Risk Level
highest
Pathway
Full Registration
Official Timeline
Min
45
Max
45
Unit
working-days
Verification Status
official-verified
Official Source
Title
Kemkes Regalkes — evaluation guideline Annex 8 service-standard clocks
Url
https://regalkes.kemkes.go.id/informasi_alkes/Indonesia%20Guideline%20for%20Evaluation%20of%20Medical%20Device%20and%20IVD%202020.pdf
Accessed Date
2026-08-25
Realistic Timeline
Min
5
Max
7
Unit
months
Prior Approval Benefits
ASEAN MRA countries
FDA
EU CE Mark
Notes
Official service-standard clock for imported Class D izin edar (new application): 45 working days of evaluation (Annex 8)
Clinical evidence required
Clinical Trial Required
Yes
Local Testing Required
Yes
Gmp Required
Yes

Expedited Pathways

Name
ASEAN Medical Device Directive (AMDD) harmonisation
Description
The AMDD gives the ten member states one device definition, one set of classification rules, one set of essential principles and one dossier structure, the Common Submission Dossier Template. It is not a reliance route. The ACCSQ Medical Device Product Working Group states in terms that the Directive is "not intended to confer mutual recognition" and that each member state retains the sovereign right to make its own registration decisions, so a registration in one ASEAN market authorises nothing in another and shortens no national review period.
Timeline Reduction
None — the saving is in dossier preparation, since one CSDT core can be reused across member states with national addenda
Eligibility
Any device filed in an ASEAN member state that has transposed the AMDD into national law

Prior Approvals

Authority
ASEAN member-state registration
Accepted
No
Benefit
There is no ASEAN mutual recognition agreement for device registration — the AMDD harmonises the dossier, not the decision
Timeline Savings
None
Authority
FDA 510(k)
Accepted
Yes
Benefit
Supports the Certificate of Free Sale and the technical evidence in the CSDT, but Kemenkes publishes no shorter period for it
Timeline Savings
None published
Authority
EU CE Mark
Accepted
Yes
Benefit
Supports the Certificate of Free Sale and the technical evidence in the CSDT, but Kemenkes publishes no shorter period for it
Timeline Savings
None published

Key Requirements

Indonesia Authorized Representative
Bahasa Indonesia labeling
Local testing from accredited labs
ISO 13485 certification
Free Sale Certificate
Annex 8 additional clocks: additional-data evaluation 10 working days (Class A/B) or 15 (Class C/D); renewal 7 working days; variation (perubahan) 10 working days

Local Rep Required

Yes

Local Rep Name

Indonesia Authorized Representative

Mdsap Accepted

Mdsap Benefit

Not accepted but ISO 13485 required

Registration Validity

5 years

Verification Status

official-verified

Official Sources

Title
Kemkes Regalkes — evaluation guideline Annex 8 service-standard clocks
Url
https://regalkes.kemkes.go.id/informasi_alkes/Indonesia%20Guideline%20for%20Evaluation%20of%20Medical%20Device%20and%20IVD%202020.pdf
Accessed Date
2026-08-25
Title
ACCSQ Medical Device Product Working Group — Implementing the ASEAN Medical Device Directive: "Not intended to confer mutual recognition; each member state retains sovereign right for registration decisions"
Url
https://www.ahwp.info/sites/default/files/6%20Implementing%20the%20ASEAN%20Medical%20Device%20Directive%201.0.pdf
Accessed Date
2026-08-30

Reviewed On

2026-08-30

Last Updated

2026-08-30

Process

Template Id

default

Status

planning-template

Usage Rule

Maintained planning steps and estimates, not verified regulator deadlines.

Steps

Step
1
Title
Pre-Submission Preparation
Description
Gather technical documentation, quality management system (QMS) records, and clinical data required by Ministry of Health. Appoint a Indonesia Authorized Representative.
Duration
1-3 months
Icon
📋
Step
2
Title
Application Submission
Description
Submit complete registration dossier to Ministry of Health including device description, risk analysis, and testing reports.
Duration
1-2 weeks
Icon
📤
Step
3
Title
Administrative Review
Description
Ministry of Health reviews application for completeness. May request additional documents or clarifications.
Duration
2-4 weeks
Icon
🔍
Step
4
Title
Technical Evaluation
Description
In-depth technical assessment of device safety and performance. Ministry of Health may issue questions.
Duration
15 working days
Icon
⚙️
Step
5
Title
Registration Approval
Description
Upon successful review, Ministry of Health issues Indonesia market authorization certificate.
Duration
1-2 weeks
Icon
✅

Government fee schedules · 1 record

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open Indonesia fees →

Country

Indonesia

Jurisdiction Id

indonesia

Country Code

Authority

Indonesia MoH

Low Risk Local

Min: 1500000
Max: 3000000
Currency: IDR
Per Product: Yes

High Risk Local

Min: 3000000
Max: 5000000
Currency: IDR
Per Product: Yes

Details

Id
registration-class-a
Item
New registration - Class A
Currency
IDR
Amount Local
1500000
Amount Local Formatted
IDR 1,500,000
Frequency
Per application
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://regalkes.kemkes.go.id/informasi_alkes/011.%20Modul%20Perizinan%20Alat%20Kesehatan.pdf
Source Title
Indonesia Ministry of Health medical-device licensing module
Verified On
2026-08-25
Id
registration-class-b
Item
New registration - Class B
Currency
IDR
Amount Local
3000000
Amount Local Formatted
IDR 3,000,000
Frequency
Per application
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://regalkes.kemkes.go.id/informasi_alkes/011.%20Modul%20Perizinan%20Alat%20Kesehatan.pdf
Source Title
Indonesia Ministry of Health medical-device licensing module
Verified On
2026-08-25
Id
registration-class-c
Item
New registration - Class C
Currency
IDR
Amount Local
3000000
Amount Local Formatted
IDR 3,000,000
Frequency
Per application
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://regalkes.kemkes.go.id/informasi_alkes/011.%20Modul%20Perizinan%20Alat%20Kesehatan.pdf
Source Title
Indonesia Ministry of Health medical-device licensing module
Verified On
2026-08-25
Id
registration-class-d
Item
New registration - Class D
Currency
IDR
Amount Local
5000000
Amount Local Formatted
IDR 5,000,000
Frequency
Per application
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://regalkes.kemkes.go.id/informasi_alkes/011.%20Modul%20Perizinan%20Alat%20Kesehatan.pdf
Source Title
Indonesia Ministry of Health medical-device licensing module
Verified On
2026-08-25

Notes

The official module distinguishes new registration from renewal/change. Renewal/change fees are lower: IDR 500,000 for Class A and IDR 1,000,000 for Classes B-D.
Domestically manufactured PKRT (perbekalan kesehatan rumah tangga) follow a separate PNBP table: IDR 1,000,000 / 2,000,000 / 3,000,000 for classes 1/2/3.
The module says the payable PNBP follows the regulations in force, so confirm the portal assessment before payment.

Last Updated

2026-08-25

Verification Status

official-verified

Official Sources

Title
Indonesia Ministry of Health medical-device licensing module
Url
https://regalkes.kemkes.go.id/informasi_alkes/011.%20Modul%20Perizinan%20Alat%20Kesehatan.pdf
Accessed Date
2026-08-25
Title
Indonesia regalkes PNBP tariff: izin edar certificate fees by class
Url
https://regalkes.kemkes.go.id/index.php/home/fileDownload/BERITA_FILE.pdf/1000786
Accessed Date
2026-08-25

Reviewed On

2026-08-25

Amount Status

exact-current

Range Available

Yes

Additional certifications and licences · 1 record

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open Indonesia certifications →

Slug

indonesia

Market

Indonesia

Confidence

low

Schemes

Id
medical-electrical-evidence
Name
Medical electrical evidence
Category
Medical Electrical Safety
Status
Included In Medical Registration
Object
Finished Device
Note
Published Ditjen Farmalkes assessment guide (Pedoman Penilaian Alat Kesehatan dan PKRT): function/performance test evidence or a QC Certificate of Analysis for the finished device; electrically powered devices need electrical-safety testing per the IEC 60601 series (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance), with the testing laboratory's ISO/IEC 17025 certificate; product-specific evidence quoted by the guide includes condoms (uji daya letup dan kebocoran) and sanitary pads (uji fluoresensi dan uji daya serap). PMK 14/2021 (as amended by PMK 8/2022 and 17/2024) was repealed in part by Permenkes 11/2025 (set 3 October 2025), which now carries the OSS health-sector business/product standards under PP 28/2025. PMK 54/2015 (device testing and calibration) was revoked by PMK 5/2026. Read the published assessment guidance subject to the current framework and the consistency condition for earlier implementing provisions in Permenkes 5/2026 Article 124.
Source Urls
https://regalkes.kemkes.go.id/informasi_alkes/PedomanPenilaianAlatKesehatandanPKRT.pdf
https://jdih.kemkes.go.id/documents/peraturan-menteri-kesehatan-nomor-11-tahun-2025
https://jdih.kemkes.go.id/documents/peraturan-menteri-kesehatan-nomor-5-tahun-2026
Source Binding
reviewed
Id
komdigi-telecommunications-device-certification
Name
Komdigi telecommunications-device certification
Category
Radio Spectrum
Status
Mandatory If Feature
Object
Covered Telecommunications Device
Source Urls
https://layanan.komdigi.go.id/layanan/detail/?id=9
Source Binding
candidate
Id
sni-compulsory-certification
Name
SNI compulsory certification
Category
General Electrical Components
Status
Mandatory If Feature
Object
Listed Product Or Component
Source Binding
unresolved
Id
medical-device-halal-class-a
Name
Medical-device halal Class A
Category
Halal And Material Origin
Status
Transition Not Yet Mandatory
Object
In Scope Class A Device
Effective Date
2026-10-18
Post Effective Status
Mandatory Pre Market
Source Urls
https://peraturan.bpk.go.id/Details/291786
Source Binding
candidate
Id
medical-device-halal-class-b
Name
Medical-device halal Class B
Category
Halal And Material Origin
Status
Transition Not Yet Mandatory
Object
In Scope Class B Device
Effective Year
2029
Source Urls
https://peraturan.bpk.go.id/Details/291786
Source Binding
candidate
Id
medical-device-halal-class-c
Name
Medical-device halal Class C
Category
Halal And Material Origin
Status
Transition Not Yet Mandatory
Object
In Scope Class C Device
Effective Year
2034
Note
Class D timing is governed separately and must remain authority-confirmation-needed until the applicable presidential rule and availability conditions are resolved.
Source Urls
https://peraturan.bpk.go.id/Details/291786
Source Binding
candidate
Id
bapeten-radiation-authorization
Name
BAPETEN radiation authorization
Category
Ionizing Radiation
Status
Mandatory If Feature
Object
Product And Use Site
Note
Current Ditjen Farmalkes assessment guide (Pedoman Penilaian Alat Kesehatan dan PKRT): devices containing ionizing radiation, such as X-ray units, require a Surat Izin Pemanfaatan Tenaga Nuklir issued by Badan Pengawas Tenaga Nuklir (BAPETEN) as part of the izin edar assessment. Locator quote: "alkes yang mengandung radiasi pengion seperti unit sinar X, dipersyaratkan Surat Izin Pemanfaatan Tenaga Nuklir yang dikeluarkan oleh Badan Pengawas Tenaga Nuklir (BAPETEN)".
Source Binding
unresolved
Id
kemenkes-import-letters
Name
Kemenkes medical-device imports and special access
Category
Import Conformity
Status
Mandatory If Feature
Object
Commercial Or Special Circumstance Imports
Note
Permenkes 5/2026 (effective 4 May 2026) Article 58(4) requires an izin edar for medical-device and PKRT imports; Article 58(5) allows the Minister to issue an import letter in specified circumstances, with procedures to be set by the Minister under Article 58(7). Article 60 provides for customs/post-border checks. Article 62 governs special access without an izin edar, including purpose-specific approval and exceptions for personal use and other enumerated needs; assess the exact purpose rather than treating every special-access shipment as requiring the same permission. Article 125 repeals, among others, PMK 14/2016 (complementary goods, market testing and after-sales import recommendations), PMK 51/2014 and 7/2020 (special access), and PMK 60/2017 (import supervision). Earlier implementing provisions survive only insofar as consistent with the new regulation (Article 124). The older published export/import guide is historical operational context and does not by itself establish current letter names, sample re-testing requirements or an exemption. Business/distributor licensing also requires the applicable OSS standards under Permenkes 11/2025.
Source Urls
https://jdih.kemkes.go.id/documents/peraturan-menteri-kesehatan-nomor-5-tahun-2026
https://jdih.kemkes.go.id/documents/peraturan-menteri-kesehatan-nomor-11-tahun-2025
Source Binding
reviewed

Official Sources

Authority
Komdigi
Topic
telecommunications-device certification
Url
https://layanan.komdigi.go.id/layanan/detail/?id=9
Authority
BPJPH
Topic
halal obligation beginning 18 October 2026
Url
https://bpjph.halal.go.id/read/tak-hanya-makanan-minuman-ini-jenis-produk-yang-wajib-bersertifikat-halal-mulai-18-oktober-2026
Authority
Republic of Indonesia
Topic
medical-device halal implementation guideline
Url
https://peraturan.bpk.go.id/Details/291786
Authority
Kementerian Kesehatan (JDIH)
Topic
Permenkes 11/2025 — current OSS health-sector business/product standards repealing PMK 14/2021 in part (set 3 October 2025, status Berlaku)
Url
https://jdih.kemkes.go.id/documents/peraturan-menteri-kesehatan-nomor-11-tahun-2025
Authority
Direktorat Jenderal Farmasi dan Alat Kesehatan
Topic
Pedoman Penilaian Alat Kesehatan dan PKRT — IEC 60601 electrical-safety evidence and BAPETEN Surat Izin Pemanfaatan Tenaga Nuklir
Url
https://regalkes.kemkes.go.id/informasi_alkes/PedomanPenilaianAlatKesehatandanPKRT.pdf
Authority
Direktorat Jenderal Farmasi dan Alat Kesehatan
Topic
Published export/import guide — historical import-letter and sample re-testing descriptions; assess continued applicability under Permenkes 5/2026
Url
https://regalkes.kemkes.go.id/informasi_alkes/Pedoman%20Ekspor%20Impor.pdf
Authority
Kementerian Kesehatan (JDIH)
Topic
Permenkes 5/2026 — current medical-device import and special-access requirements (Articles 58, 60, 62), implementing-rule transition and repeals (Articles 124–126), effective 4 May 2026
Url
https://jdih.kemkes.go.id/documents/peraturan-menteri-kesehatan-nomor-5-tahun-2026

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2021 guide: historical simultaneous-change submission rule

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Indonesia approvals and evidence in other markets (0 records)

Prior approvals and evidence for Indonesia (8 records)

Indonesia import permit required; NMPA reliance eligibility not resolved by this clause

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