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Ministry of Health · South & Southeast Asia

Indonesia medical device regulatory resources

Every Indonesia dataset, comparison, and AI workpaper we maintain — one entry point for the whole market.

82,164 registration records11 free resources24/25 topics with records14 regulations trackedAug 2026 fees reviewed
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Medical device registration database

Search official Ministry of Health device registration records.

Medical device registry insights

Explore market trends, registrations, manufacturers, and local representatives.

Medical device regulations

Browse official Ministry of Health regulations and guidance documents.

Registration timeline

Compare official and realistic approval times by device class and pathway.

Government registration fees

Review current Ministry of Health application, review, and renewal fees.

AI registration cost and timeline planner

Estimate the likely Ministry of Health pathway, government fees, dossier preparation time, review timeline, and registration steps.

Medical device regulation news

Follow recent Ministry of Health policy, guidance, and compliance updates.

AI medical device classifier

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Additional certification and licence checker

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AI similar registered product finder

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Regulatory requirements data

Browse source-linked lifecycle, language, local-role, renewal, and change-control facts.

Changes after registration

Explore questions and sources →

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

Structured regulatory requirements

Explore all 56 source-linked facts →

24 of 25 research dimensions currently covered · 22 official sources · latest verification 2026-10-26

Market entry

D01

Authority & regime

Verified
Competent authority
The Minister of Health (Menteri Kesehatan) of the Republic of Indonesia is the authority for medical devices and household health supplies (PKRT); the responsible unit is the Director Gener…
Allocation between Ministry of Health and BPOM
Under PMK 5/2026, safety/quality control of devices (Alat Kesehatan) and PKRT is performed by the Minister of Health, while control of Sediaan Farmasi and PKMK is performed according to reg…
2 source-linked facts
Checked 2026-08-25
Open details →
D02

Legal basis & guidance

Verified
Surviving technical annexes of revoked regulations
PMK 5/2026 revoked several device regulations but preserved parts: PMK 4/2014 (CDAKB/GDPMD) survives except Pasal 2 and its Annex; PMK 20/2017 (CPKB/device GMP) survives except Pasal 2 and…
Primary legal framework
Framework chain: Law 17/2023 on Health (Pasal 138, 143) as primary law; Permenkes 5/2026 on Perbekalan Kesehatan (in force 4 May 2026) as the operative device framework, revoking PMK 62/201…
3 source-linked facts
Checked 2026-08-25
Open details →
D03

Device definition & scope

Verified
Device definition and scope
Alat Kesehatan (medical device) is defined as any instrument, apparatus, machine, equipment, implant, in vitro reagent and calibrator, software, or similar material used on humans for medic…
1 source-linked fact
Checked 2026-08-25
Open details →
D05

Registration pathways

Verified
Possibility of product grouping
Some medical device products can be registered in one product package/grouping.
Marketing authorization requirement
Health supplies (including all medical devices and PKRT) may only be placed on the market after obtaining the business licence in the form of an izin edar (marketing authorization); the lic…
4 source-linked facts
Checked 2026-10-26
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D06

Reliance & recognition

Verified
Indonesian import authorisation remains required
PMK 5/2026 Pasal 58(4) requires a Minister issued izin edar for importing medical devices and PKRT, subject to the specified exceptions. It does not establish whether an abridged or relianc…
3 source-linked facts
Checked 2026-09-15
Open details →
D07

Economic-operator roles

Verified
Consequences of distributor/appointment change
Termination of the producer's appointment of the distributor/importer is an explicit ground for revocation of the device izin edar (PMK 5/2026 Pasal 51(1)(d)), and the izin edar lapses when…
Applicants for import marketing authorization
Import izin edar applications are filed by: (a) the Sole Agent/Sole Distributor/Exclusive Distributor; (b) a licensed importer (PAK) appointed and empowered by the manufacturer/principal; (…
3 source-linked facts
Checked 2026-08-25
Open details →
D08

Establishment, import & distribution

Verified
Distribution restricted to licensed operators under CDB
Distribution of medical devices may only be performed by pharmaceutical management facilities, device producers, and device distributors holding a business licence (perizinan berusaha); dis…
Import conditions
Import of devices/PKRT may proceed only after obtaining an izin edar from the Minister; imports are processed through an electronic system integrated with the Indonesia National Single Wind…
4 source-linked facts
Checked 2026-10-26
Open details →
D09

Dossier requirements

Verified
Documents for imported-device variations
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 a…
3 source-linked facts
Checked 2026-10-26
Open details →
D10

Official forms & portals

Verified
Official systems
Product registration runs on e Regalkes (regalkes.kemkes.go.id, User ID login) integrated with OSS RBA; import documentation runs through INSW; the e SUKA portal (esuka.kemkes.go.id, Direct…
1 source-linked fact
Checked 2026-08-25
Open details →

Submission & evidence

D11

Label, IFU & language

Verified
Relabelling after permit or distributor identity changes
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.
Bahasa Indonesia requirement
Intended use/purpose, instructions for use, contraindications, cautions and warnings on device labelling and information must be in Bahasa Indonesia; languages other than Indonesian are per…
3 source-linked facts
Checked 2026-10-26
Open details →
D12

QMS, audit & inspection

Verified
Device GMP (CPB) obligation
Production of health supplies must comply with Cara Pembuatan yang Baik (CPB), evidenced by a certificate issued under the applicable rules; the CPB for devices and PKRT is set by the Minis…
1 source-linked fact
Checked 2026-08-25
Open details →
D13

Standards, testing & ancillary approvals

Unresolved
Medical electrical evidence
Electrical safety
Komdigi telecommunications-device certification
Wireless / radio
SNI compulsory certification
Adapters / components
8 maintained overlays
Open details →
D15

Review clocks

Verified
Class A · Notification
15 working days
Class B · Registration
30 working days
Class C · Full Registration
30 working days
4 maintained pathways · 3 related facts
Checked 2026-10-26
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D16

Approval validity & renewal

Verified
Expiry or lapse consequence
If the extension application is filed after the validity has expired, it follows the rules for a new izin edar application; once validity has expired without an approved extension, the devi…
Renewal timing
Under the PMK11/2025 imported device PB UMKU standard, a renewal application must be submitted no later than 9 months before the PB UMKU validity expires (paling lambat9bulan sebelum masa b…
4 source-linked facts
Checked 2026-10-26
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Lifecycle & post-market

D17

Change control

Verified
Administrative changes affecting all manufacturer labelling
For administrative changes affecting labelling of all products of a manufacturer, the marketing authorization holder must notify the Ministry of Health.
Change-control outcomes
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 ma…
8 source-linked facts
Checked 2026-10-26
Open details →
D18

UDI, listing & traceability

Verified
KFA reference-identifier document linkage
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…
Public listing registry
Registered devices and PKRT (domestic and imported), licensed distributors (IDAK) and producers are listed in the official public registry e Info Alkes dan PKRT (infoalkes.kemkes.go.id), wh…
2 source-linked facts
Checked 2026-10-26
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D19

Clinical investigation & performance

Verified
Local clinical trial approval
Clinical investigations of health supplies must comply with Cara Uji Klinik yang Baik (CUKB, device GCP) and obtain a clinical trial approval letter (surat persetujuan pelaksanaan uji klini…
2 source-linked facts
Checked 2026-10-26
Open details →
D20

Special access & derogation

Verified
Emergency use authorization
In emergencies, disasters, extraordinary events (KLB), epidemics or health crises, health supplies may be circulated under an emergency use authorization (EUA) issued by the Minister (for d…
Special access scheme (jalur khusus)
In defined circumstances devices and PKRT may be imported without an izin edar through the special route (jalur khusus) mechanism with the Minister's approval, for purposes of: healthcare s…
2 source-linked facts
Checked 2026-08-25
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D21

Manufacturer PMS

Verified
Post-market sampling duty
The izin edar holder of devices and PKRT must perform sampling and testing at least once during the validity period of the authorization; testing of samples is carried out by accredited lab…
Shortage reporting
The izin edar holder must report potential shortages of health supplies to the Minister at the latest 6 months before the shortage occurs; the Ministry responds through accelerated izin eda…
2 source-linked facts
Checked 2026-08-25
Open details →
D22

Vigilance & incident reporting

Verified
Vigilance duty and reporting channel
The izin edar holder must operate device vigilance ('vigilans': detection, assessment, understanding, communication, control and prevention of adverse effects or other problems related to d…
1 source-linked fact
Checked 2026-08-25
Open details →
D23

Recall, FSCA & market surveillance

Verified
Recall duty and reporting
Health supplies not meeting safety/benefit/quality standards or labelling requirements must be withdrawn from circulation by the izin edar holder and/or business operators, either on the or…
1 source-linked fact
Checked 2026-08-25
Open details →
D24

Advertising, claims & promotion

Verified
Advertising restriction for professional-use devices
Devices whose use requires the assistance of medical or health personnel may only be promoted and advertised in scientific media for medical and health personnel (media ilmiah untuk tenaga…
1 source-linked fact
Checked 2026-08-25
Open details →
D25

Submission communications & appeal

Verified
Decision communication
Applicants receive notification of the izin edar issuance or the digitally signed rejection letter by e mail and SMS to the registered company contact, and download the license or rejection…
1 source-linked fact
Checked 2026-08-25
Open details →

Government fees

Full fee schedule (4 lines) →

Indonesia MoH registration fees in IDR · reviewed 2026-08-25

Fee lineAmountProvenance
New registration - Class AIDR 1,500,000Verified
New registration - Class BIDR 3,000,000Verified
New registration - Class CIDR 3,000,000Verified
New registration - Class DIDR 5,000,000Verified

Registration timeline

Full registration timeline →

Ministry of Health (Ministry of Health) review clocks and planning ranges · 4-class (A, B, C, D) classification

Class / pathwayReview clockPlanning totalProvenance
Class A(Notification)

Official service-standard clock for imported Class A izin edar (new application): 15 working days of evaluation (evaluation guideline Annex 8)

Simplified notification

15 working days2-4 monthsVerified
Class B(Registration)

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

ASEAN harmonization applies

30 working days4-6 monthsVerified
Class C(Full Registration)

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

Clinical data may be required

30 working days4-6 monthsVerified
Class D(Full Registration)

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

Clinical evidence required

45 working days5-7 monthsVerified
  1. 1Pre-Submission Preparation(1-3 months)
  2. 2Application Submission(1-2 weeks)
  3. 3Administrative Review(2-4 weeks)
  4. 4Technical Evaluation(15 working days)
  5. 5Registration Approval(1-2 weeks)

Latest regulation news

All Indonesia regulation news →

Newest official Ministry of Health headlines from the daily-refreshed feed — every row links directly to the authority publication.

Sep 8MOMinistry of HealthIndonesian MoH Publishes First Revision of Ditjen Farmalkes Strategic Program Action Plan 2025–2029Indonesia

Key regulations

All 14 Indonesia regulations →

Official Ministry of Health rules and guidance · 14 of 14 documents linked to official sources

CDAKB CertificationGood Distribution Practice for Medical Devices (CDAKB) Portal
GMP/QMSVerified
Pedoman KlasifikasiPedoman Klasifikasi Alat Kesehatan (AMDD-Harmonized Classification Guide)
ClassificationVerified
Evaluation Guidelines 2020Guidelines for Evaluation of Medical Devices and In Vitro Diagnostics
RegistrationVerified
Farmalkes PortalPharmaceutical and Medical Device Information System
RegistrationVerified

Registry insights

Full registry statistics →

Computed from 82,164 official Kemenkes registration records · data as of 2026-08-26

New registrations by year
202120222023202420252026
VerifiedKemenkes registry · as of 2026-08-26
82,164
Registrations
14,392
Manufacturers
4,773
Authorized Representatives
64
Origin countries
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Indonesia market-launch workpaper

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Indonesia dossier reuse and delta

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Indonesia change notification workpaper

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Indonesia regulatory change impact

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