Ministry of Health market access

Indonesia medical device registration resources

Research Ministry of Health registration records, classification, regulations, timelines, fees, and market updates — the stable entrance to every Indonesia medical device resource.

82,164 registration records11 free resources24/25 requirements covered9 regulations trackedAug 2026 fees reviewed

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Medical device registration database

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Medical device registry insights

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Medical device regulations

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Registration timeline

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Government registration fees

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Medical device regulation news

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Additional certification and licence checker

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Regulatory requirements data

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Structured regulatory requirements

Explore all 44 source-linked facts →

24 of 25 research dimensions currently covered · 14 official sources · latest verification 2026-08-30

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

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D02

Legal basis & guidance

Verified

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…
Transition period: Implementing arrangements for health supply regulation must be adjusted to PMK 5/2026 within at most 1 year from its promulgation (i.e. by 4 May 2027); until then pre existing implementing…

3 source-linked facts

Checked 2026-08-25

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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

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D04

Classification rules

Verified

Risk classes A through D.: Class A, Class B, Class C, Class D

1 maintained scheme

Checked 2026-08-25

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D05

Registration pathways

Verified

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…
Notification route for certain class A devices: Certain home use class A devices qualify for an 'izin edar notifikasi' (notification marketing authorization) with simplified requirements. 'Certain class A' means home use devices usable i…

3 source-linked facts

Checked 2026-08-25

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D06

Reliance & recognition

Verified

Certificate of Free Sale requirement: Import izin edar applications must be accompanied by a Certificate of Free Sale (CFS) issued by the health authority of the country of manufacture; if that authority does not issue CFS, it…
No recognition of foreign approvals as authorization: Indonesia does not operate a reliance route that recognizes a foreign marketing authorization in place of local review: import of devices may only take place after an Indonesian izin edar f…

2 source-linked facts

Checked 2026-08-25

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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

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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…
Distributor licence (Izin DAK) duration and CDAKB: A device distributor (Distributor Alat Kesehatan) must be a limited company (PT) or cooperative and holds an Izin Distribusi Alat Kesehatan (Izin DAK/IDAK) under KBLI 46691. The business li…

4 source-linked facts

Checked 2026-08-25

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D09

Dossier requirements

Verified

General dossier requirements for import applications: For new, extension, variation and extension with variation import applications: valid Izin DAK covering the product group; agency appointment letter (surat penunjukan keagenan) from the man…
QMS and conformity evidence in the dossier: Technical dossier for import classes A D must include an ISO 13485 certificate (latest edition) from an accredited certification body naming the manufacturer as on the CFS, with scope cover…

2 source-linked facts

Checked 2026-08-25

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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

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Submission & evidence

D11

Label, IFU & language

Verified

Label elements: Device/IVD labels and information must state at least: trade name/brand; izin edar number; product type; manufacturer name and address; name and address of the authorization holder PAK; bat…
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…

2 source-linked facts

Checked 2026-08-25

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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

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D13

Standards, testing & ancillary approvals

Unresolved

Medical electrical evidence: Electrical safety
Komdigi telecommunications-device certification: Wireless / radio
SNI compulsory certification: Adapters / components

7 maintained overlays

Checked 2026-08-29

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D14

Fees

Verified

New registration - Class A: IDR 1,500,000
New registration - Class B: IDR 3,000,000

4 maintained fee lines · 1 related fact

Checked 2026-08-25

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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 · 2 related facts

Checked 2026-08-30

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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: The authorization holder must file the extension application at the earliest 9 months before the validity expires (paling cepat 9 bulan sebelum masa berlaku habis). Device izin edar is expl…

4 source-linked facts

Checked 2026-08-25

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Lifecycle & post-market

D17

Change control

Verified

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…
New-application triggers: Any change other than size, packaging, labelling, accessories/annexes or the authorized representative's name/address requires a new izin edar application (e.g. product, manufacturer or fun…

2 source-linked facts

Checked 2026-08-25

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D18

UDI, listing & traceability

Verified

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…

1 source-linked fact

Checked 2026-08-25

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D19

Clinical investigation & performance

Verified

Clinical evidence requirement: Clinical evidence is required for class C and D devices and for new devices impacting human safety and health; it may take the form of a systematic literature study, clinical evidence on si…
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 2026-08-25

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D20

Special access & derogation

Verified

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…
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…

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

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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

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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

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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

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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

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Government fees

Full fee schedule (4 lines) →

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

Fee line	Amount	Provenance
New registration - Class A	IDR 1,500,000	Verified
New registration - Class B	IDR 3,000,000	Verified
New registration - Class C	IDR 3,000,000	Verified
New registration - Class D	IDR 5,000,000	Verified

Registration timeline

Full registration timeline →

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

Class / pathway	Review clock	Planning total	Provenance
Class A(Notification)	15 working days	2-4 months	Verified
Class B(Registration)	30 working days	4-6 months	Verified
Class C(Full Registration)	30 working days	4-6 months	Verified
Class D(Full Registration)	45 working days	5-7 months	Verified