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Ministry of Health · structured requirements

🇮🇩 Indonesia medical device regulatory data

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

45 facts23 dimensions8 official sourceslatest verification 2026-09-15

Advertising, claims & promotion

Which claims, audiences, channels, approvals, and restrictions apply?

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Advertising restriction for professional-use devices

ads.professional-devices-restricted-media
Fact-level verified

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 medis dan tenaga kesehatan). Promotion and advertising of any health supply must give objective, complete and non-misleading information on benefits, contraindications, side effects and usage precautions, and comply with advertising ethics; the promotion/advertising procedure for devices and PKRT is set by the Minister.

Conditions
  • All device classes; consumer-media advertising is restricted to devices not requiring professional assistance.
  • PMK 76/2013 (device advertising permits) was revoked by PMK 5/2026 (Pasal 125 s); the e-Iklan application on Regalkes continues to operate pending new implementing rules.

Effective from 2026-05-04

Sanction for non-compliant advertising: administrative sanctions (Pasal 117(1)(e)).

Approval validity & renewal

What expires, what is retained periodically, and when must renewal start?

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Expiry or lapse consequence

authorization.lapse
Fact-level verified

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 device is prohibited from circulation. Products whose izin edar has expired and was not extended must be withdrawn from distribution (recall ground) and are subject to destruction.

Conditions
  • All classes.

Effective from 2018-01-12

Confirms baseline fact. Recall ground for expired licences: PMK 5/2026 Pasal 86 huruf e; destruction duty: Pasal 89(1)(d).

OSS licence validity principle

authorization.oss-licence-validity
Fact-level verified

Under the electronic integrated licensing regime (PMK 26/2018, in force 12 July 2018), the business licence (Izin Usaha) is valid for as long as the business operator runs its business, while commercial/operational licences are valid 5 years and extendable; branch device-distribution licences follow the head-office certificate.

Conditions
  • Business/commercial licences in the health sector.
  • PMK 26/2018 was later declared no longer in force; the 5-year renewable pattern for the device distribution licence continues under PMK 14/2021 KBLI 46691.

Effective from 2018-07-12

Recorded to preserve the OSS validity principle distinct from the product-level izin edar validity.

Renewal timing

authorization.renewal
Fact-level verified

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 explicitly excluded from the general 6-months-before-expiry OSS extension rule of PMK 26/2018 Pasal 87(1) (exemption letter a). Before applying, the holder must have submitted electronic production/distribution reports (e-Report); a renewal cannot be processed if reporting was nil for the 2 years preceding expiry.

Conditions
  • All classes.
  • Renewal applications filed after expiry are treated as new applications.

Effective from 2018-01-12

Corrects baseline fact which said 'apply from 6 months before expiry'; PMK 26/2018 Pasal 87(2)(a) excludes device izin edar from the 6-month rule, so the 9-month rule applies. Verified in PMK 26/2018 text.

Authorization validity

authorization.validity-5-years
Fact-level verified

The device/PKRT izin edar is valid for at most 5 years; where held through a sole/exclusive agency appointment the validity follows the appointment (which must run at least 2 and at most 5 years; if unlimited or over 5 years, the izin edar runs 5 years from the appointment); OEM-product izin edar is valid at most 3 years. Validity may be extended if requirements are met.

Conditions
  • All classes.
  • The izin edar also lapses when the production certificate or PAK licence expires, or when the appointment ends (PMK 62/2017 Pasal 25).

Effective from 2018-01-12

PMK 62/2017 revoked 4 May 2026; validity rules continue pro tempore per PMK 5/2026 Pasal 124 (which still refers to expired izin edar and perpanjangan, e.g. Pasal 86 huruf e). OSS business licences follow PMK 14/2021 (IDAK 5 years).

Authority & regime

Which authority and binding regime govern this product, task, and date?

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Competent authority

authority.competent-authority
Fact-level verified

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 General for pharmaceutical and medical device affairs (Direktur Jenderal Kefarmasian dan Alat Kesehatan).

Conditions
  • Applies to all device classes and to PKRT.
  • Pharmaceutical products (Sediaan Farmasi) fall to the head of the food and drug authority (BPOM), not to the Minister.

Effective from 2026-05-04

Confirms and upgrades baseline fact; PMK 5/2026 definitions. Division of tasks: device vigilance/recall/advertising/izin edar report to the Minister (e.g. Pasal 104, 87, 84), drugs to the BPOM head.

Allocation between Ministry of Health and BPOM

authority.device-vs-drug-split
Fact-level verified

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 regulations of the head of the non-ministerial government agency for food and drug supervision (BPOM).

Conditions
  • Devices and PKRT only; not pharmaceuticals.

Effective from 2026-05-04

Same split appears for vigilance (Pasal 104), recall (Pasal 87) and advertising (Pasal 84).

Change control

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

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Change-control outcomes

change.available-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.

New-application triggers

change.new-application-triggers
Fact-level verified

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 functional specification changes).

Conditions
  • All classes.

Effective from 2018-01-12

Confirms baseline fact; importer/appointment changes additionally trigger lapse or revocation (PMK 5/2026 Pasal 51(1)(d), PMK 62/2017 Pasal 25(d)).

Clinical investigation & performance

Which clinical or IVD performance evidence or study is required and accepted?

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Clinical evidence requirement

clinical.evidence-required-classes-c-d
Fact-level verified

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 similar devices, or a clinical investigation. A clinical investigation is required where the manufacturer has no clinical evidence. Preclinical results (biocompatibility/biological evaluation) are required only for class C and D devices.

Conditions
  • Class A/B applications do not require the preclinical biocompatibility package or clinical evidence section.

Effective from 2021-04-01

Literature references must be attached and remain relevant; performance claims require supporting data (huruf l point 10).

Local clinical trial approval

clinical.trial-approval-and-gcp
Fact-level verified

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 klinik); trial organisers must register the trial. The CUKB for devices is set by the Minister.

Conditions
  • Trials with human subjects conducted in Indonesia.
  • Parts of PMK 63/2017 (device GCP) survive via PMK 5/2026 Pasal 125 ii exception.

Effective from 2026-05-04

Trial objectives include registration-supporting evidence for izin edar (Pasal 35(3)(d)).

Device definition & scope

Is the product a device, IVD, accessory, software, or borderline product locally?

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Device definition and scope

device.definition-includes-software-and-ivd
Fact-level verified

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 medical purposes whose principal action is not achieved by pharmacological, immunological or metabolic means. IVDs (in-vitro reagents and calibrators) and software are inside this single definition; the former separate 'Alat Kesehatan Diagnostik In Vitro' category of PMK 62/2017 no longer appears as a distinct licence category in PMK 5/2026. PKRT (household health supplies) is a separate defined category.

Conditions
  • Definition applies to all classes.
  • Contraception/disinfection/in-vitro examination materials and devices containing a drug not achieving its principal action pharmacologically are also devices (PMK 62/2017 Pasal 2, continuing pro tempore; same wording repeated in PMK 14/2021 standards).

Effective from 2026-05-04

Former IVD-specific izin edar standards remain as OSS product standards 60-61 under PMK 14/2021 pending new implementing rules.

Dossier requirements

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

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General dossier requirements for import applications

dossier.import-general-requirements
Fact-level verified

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 manufacturer/principal legalized by the Indonesian government representative in the origin country, valid max 5 years; valid CFS from the origin country authority; stamped declaration of willingness to relinquish the agency; trademark certificate for OEM imports; stamped statement of document authenticity; integrity pact; PNBP payment (non-refundable). New applications must additionally submit SOPs for complaint handling, adverse events, product recall and other post-market product information.

Conditions
  • Imported devices and PKRT.
  • For products assembled/repackaged in Indonesia, a valid device production licence (izin produksi) must be attached.

Effective from 2021-04-01

Legalization of the appointment letter by the Indonesian embassy/consulate is the key local delta vs. ASEAN CSDT.

QMS and conformity evidence in the dossier

dossier.qms-evidence
Fact-level verified

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 covering the device type; where devices are not regulated in the manufacturer's country, ISO 9001 is accepted; a CE certificate must be included if a numbered CE mark is on the labelling; plus the manufacturer's Declaration of Conformity against the standards used (SNI, ISO, pharmacopoeia etc.). Domestic applications accept SNI ISO 9001/ISO 9001 and/or SNI ISO 13485/ISO 13485, CE certificate if CE-marked, and a CPAKB (device GMP) certificate where already held.

Conditions
  • Class A-D; product information elements (intended use, instructions for use, contraindications, warnings, precautions) must be in Bahasa Indonesia.

Effective from 2021-04-01

QMS certificate must remain valid at time of submission.

Economic-operator roles

Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?

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Consequences of distributor/appointment change

market-entry.representative-change
Fact-level verified

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 the appointment as sole/exclusive agent or power of attorney expires or is not extended (PMK 62/2017 Pasal 25(d)). A new appointed importer must therefore register the product anew (one importer per brand, Pasal 13).

Conditions
  • Imported products.
  • Does not apply to domestic producer-held authorizations.

Effective from 2026-05-04

Corrects baseline fact: handover practicalities were advisory; the binding rules are revocation/lapse on appointment termination plus the single-importer rule. PMK 62/2017 Pasal 25(d) continues pro tempore per PMK 5/2026 Pasal 124.

Applicants for import marketing authorization

roles.import-applicants
Fact-level verified

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; (c) a PAK owning the product with a cooperation agreement with the manufacturer; (d) a PAK performing assembly; or (e) a PAK performing repackaging. Domestic applications are filed by the producer, toll manufacturer, assembler, product-owner PAK with cooperation agreement, or OEM producer.

Conditions
  • Foreign manufacturers cannot hold the authorization themselves; an Indonesian legal entity is required.

Effective from 2018-01-12

PMK 62/2017 revoked 4 May 2026; provisions continue pro tempore per PMK 5/2026 Pasal 124.

One importer per brand

roles.sole-agency-single-importer
Fact-level verified

Each type of imported device/PKRT with one trade name/brand from one manufacturer or principal may be agency-held by only one PAK (licensed importer) or PKRT importer.

Conditions
  • Imported products.

Effective from 2018-01-12

Appointments as sole/exclusive agent must run at least 2 and at most 5 years (Pasal 24(3)); where no term or a term over 5 years is given, the izin edar is valid 5 years from appointment (Pasal 24(4)).

Establishment, import & distribution

Which establishment licences, importer permissions, and distribution controls apply?

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Branch distributor requirements

establishment.branch-distributor
Fact-level verified

A branch distributor licence requires: non-individual business (PT/cooperative), PNBP payment, the head office's Izin DAK, the head office's CDAKB certificate, technical responsible person data, a statement to comply with CDAKB, with 1 year from OSS approval to fulfil the requirements; the branch licence validity follows the head-office certificates.

Conditions
  • Branches of device distributors.

Effective from 2021-04-01

PMK 26/2018 Pasal 86(3)(b) and (4)(b) previously provided that branch distribution licences follow the head-office certificate.

Distribution restricted to licensed operators under CDB

establishment.distribution-licensed-operators-only
Fact-level verified

Distribution of medical devices may only be performed by pharmaceutical-management facilities, device producers, and device distributors holding a business licence (perizinan berusaha); distribution must follow Cara Distribusi yang Baik (CDB), and the CDB for devices is set by the Minister.

Conditions
  • All device classes.
  • Producers and distributors must hold perizinan berusaha under the OSS risk-based system.

Effective from 2026-05-04

CDB technical annex of PMK 4/2014 (CDAKB) survives except Pasal 2 and its annex (PMK 5/2026 Pasal 125 v).

Distributor licence (Izin DAK) duration and CDAKB

establishment.idak-5-years-cdakb
Fact-level verified

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 licence is valid 5 years and must be extended; the extension requires holding a CDAKB (GDPMD) certificate, and a full-time technical responsible person (PJT) with CDAKB training certificate is required.

Conditions
  • Distributors and branch distributors of devices (KBLI 46691).
  • Distributors of electromedical devices additionally need own (or partnered) technicians and a workshop; distributors of radiation-emitting electromedical devices need a BAPETEN nuclear-utilization licence and a level-1 medical radiation protection officer.

Effective from 2021-04-01

Applicants have a 1-year fulfilment window from OSS approval to meet CDAKB-related obligations.

Import conditions

import.license-and-insw
Fact-level verified

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 Window (INSW). In special circumstances the Minister may issue an import certificate (surat keterangan impor) for devices/PKRT, and used (non-new) devices may be imported for certain purposes subject to safety, benefit and quality requirements.

Conditions
  • Importers must be licensed business operators (PMK 5/2026 Pasal 57(2)).
  • The izin edar is checked as a customs (border) or post-border document against tax ID/NIB, izin edar number and HS code (Pasal 60).

Effective from 2026-05-04

Replaces PMK 60/2017 import surveillance regime (revoked by PMK 5/2026 Pasal 125 gg).

Fees

What regulator fee applies to this class, route, event, and date?

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Fee payment rules

fees.pnbp-nonrefundable-epayment
Fact-level verified

Every izin edar application is subject to a non-tax state revenue (PNBP) charge payable by e-payment (manual only in force majeure); fees already paid cannot be refunded, including for expired or rejected applications.

Conditions
  • All classes, new/extension/variation applications.

Effective from 2018-01-12

Fee amounts by class are recorded as typed findings (D14). Guideline: billing code must be paid and receipt uploaded within 7 days.

Label, IFU & language

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

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Bahasa Indonesia requirement

label.bahasa-indonesia-mandatory
Fact-level verified

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 permitted only where no Indonesian equivalent exists or can be created, or for goods traded abroad.

Conditions
  • All device classes and PKRT.

Effective from 2018-01-12

OSS dossier standards likewise require intended use, instructions, contraindications, warnings in Bahasa Indonesia (PMK 14/2021 product information elements).

Label elements

label.minimum-elements
Fact-level verified

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; batch/production code/serial number; the word 'steril' and sterilization method for sterile products; product specifications; intended use and instructions for use; expiry date where applicable; and for certain devices that must be used by competent professionals the warning 'Hanya Boleh Digunakan oleh Tenaga Profesional' or the letter 'P' in white on black background.

Conditions
  • All device classes; separate (lighter) element lists apply to PKRT.

Effective from 2018-01-12

PMK 5/2026 Pasal 52(1) restates the general duty (marking with safety, benefit, instruction information) for all health supplies; PMK 62/2017 detail continues pro tempore per Pasal 124.

Manufacturer PMS

Which PMS plan, report, PMCF or PMPF, trend, and lifecycle-update duties apply?

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Post-market sampling duty

pms.sampling-once-per-validity
Fact-level verified

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 laboratories, and sampling/testing activities are reported through the health information system integrated with the national health information system.

Conditions
  • All device authorization holders.

Effective from 2026-05-04

New-market surveillance tools: routine and incidental sampling by the Ministry and regional governments (Pasal 101(1)).

Shortage reporting

pms.shortage-report-6-months
Fact-level verified

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 edar and the special-route mechanism.

Conditions
  • All authorization holders.

Effective from 2026-05-04

Producers, distributors and facilities must also report their activities through the integrated health information system (Pasal 96(1)(d)); device e-Report duty also gates renewal (PMK 62/2017 Pasal 26(2)).

Official forms & portals

Which current form, portal, account, and submission package must be used?

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Official systems

portals.registration-and-certificate-systems
Fact-level verified

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, Directorate of Production and Distribution of Medical Devices) unifies 10 certificate types including CFS, Certificate of Export, Health Certificate and Research-Use-Only certificates, with PNBP e-payment. Related systems: SIKLARA, e-Watch, e-Report, infoalkes, e-Iklan.

Conditions
  • All applicants.

Regalkes homepage confirms its izin edar role and links the sub-systems. Renewal applications are filed via the INSW portal or regalkes.kemkes.go.id (PMK 62/2017 Pasal 27(1)).

QMS, audit & inspection

Which QMS, audit, inspection, and certificate scope is accepted or required?

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Device GMP (CPB) obligation

qms.cpb-certificate-required
Fact-level verified

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 Minister. Production facilities need full-time competent responsible persons with CPB training certificates, and contract/licence manufacturing must likewise hold a CPB certificate for the product type produced.

Conditions
  • Domestic production facilities (industri, usaha kecil, usaha mikro).
  • Not applicable to foreign manufacturers, who evidence ISO 13485/ISO 9001 in the dossier instead.

Effective from 2026-05-04

The technical CPB annex for devices (CPAKB) of PMK 20/2017 survives except Pasal 2 and Annexes I-II (PMK 5/2026 Pasal 125 ee). Inspections of production and distribution facilities are conducted under PMK 5/2026 Pasal 102.

Recall, FSCA & market surveillance

Which recall, FSCA, notice, and authority-coordination duties apply?

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Recall duty and reporting

recall.mandatory-withdrawal-and-reporting
Fact-level verified

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 order of the Minister (for devices) or on the operator's own initiative. Recall triggers include sampling/testing results, complaint verification, inspections, the rapid-alert system, an izin edar that expired without extension, and revoked izin edar or EUA. The recalling operator must document the recall and report it to the Minister through the integrated health information system; recall procedure (tata cara) for devices is set by the Minister.

Conditions
  • All device classes.
  • Destruction of non-compliant, unlicensed, revoked, expired or outdated products is separately mandated (Pasal 89-90) and must be documented and reported (Pasal 92).

Effective from 2026-05-04

Sanctions for failure to recall include administrative fines and police-power measures incl. forced recall and destruction (Pasal 117(2)-(3)).

Registration pathways

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

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Notification route for certain class A devices

registration.class-a-notification-route
Fact-level verified

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 independently without special skill/health personnel, that are not sterile and not IVDs. PKRT classes 1 and 2 have an analogous notification route.

Conditions
  • Class A devices only, non-sterile, non-IVD, home-use.
  • Classes B, C, D and all other class A devices follow the full evaluation route.

Effective from 2021-04-01

Domestic-device product standards (Standar 61) carry the same class A-D service structure.

Marketing authorization requirement

registration.izin-edar-required
Fact-level verified

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 licensed product must meet safety, efficacy/benefit and quality criteria.

Conditions
  • All classes A-D, domestic and imported.

Effective from 2026-05-04

Echoes Law 17/2023 Pasal 143(1) business-licensing requirement.

Market-access route and official registration surface

registration.market-access-route
Fact-level verified

The local licence holder (imported products: appointed Indonesian distributor/PAK; domestic: producer) applies for izin edar by class-based evaluation through the Kemenkes e-Regalkes portal (regalkes.kemkes.go.id), after OSS-RBA business licensing; izin edar certificates and rejection letters are issued digitally.

Conditions
  • All classes.
  • Company registration and OSS NIB/KBLI precede product application.

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 (10 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 clocksACCSQ 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

Kemkes Regalkes — evaluation guideline Annex 8 service-standard clocksACCSQ 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

IndonesiaISO · EU conformity assessment

Regulatory reference

Indonesian import authorisation remains required

reliance.no-foreign-approval-waiver
Fact-level verified

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 reliance assessment is available in obtaining that local permit.

Conditions
  • Read with Pasal 58(5) and the special-access provisions of Pasal 62.

Effective from 2026-05-04

The former wording incorrectly inferred absence of reliance from a local permit requirement.

IndonesiaUS FDA · EU conformity assessment · ASEAN

Prior approval / evidence record

Class C

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

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

Kemkes Regalkes — evaluation guideline Annex 8 service-standard clocksACCSQ 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

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
Kemkes Regalkes — evaluation guideline Annex 8 service-standard clocksACCSQ 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

IndonesiaSource authority not specified

Regulatory reference

Certificate of Free Sale requirement

reliance.cfs-from-country-of-origin
Pending verification

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 may be issued by the health authority of another country regulating devices, or (if the product is not registered in the origin country) by another institution in the origin country. The CFS must state at least trade name/brand, product type, manufacturer name and address, and validity.

Conditions
  • Imported devices and PKRT.
  • Agency appointment letter must be legalized by the Indonesian government representative in the origin country (PMK 14/2021 general requirements).

Effective from 2018-01-12

Peraturan Menteri Kesehatan Nomor 5 Tahun 2026 tentang Perbekalan Kesehatan

PMK 62/2017 is expressly revoked by PMK 5/2026 Pasal 125(hh), effective 4 May 2026. Pasal 124 preserves non-conflicting implementing provisions, and Pasal 122 gives an adjustment period. These provisions do not independently establish that this precise repealed CFS clause remains applicable. Re-check the current implementing/OSS instrument before using this as a current requirement.

IndonesiaUS FDA · EU conformity assessment · ASEAN

Prior approval / evidence record

Class D

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

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

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

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?

Compare countries

Applicant deficiency-response clock

clocks.deficiency-response-deadline
Fact-level verified

When additional documentation is requested, the applicant must complete it within at most 10 days of the notification for classes A, B and C, and 15 days for class D; if the deadline is missed the application expires and the PNBP fee is forfeited.

Conditions
  • All izin edar applications (new, extension, variation).

Official service-standard guideline in force on the e-registration site; stop-clock effect: the evaluation clock pauses while the applicant gathers the requested data.

Applicant payment clock

clocks.payment-7-days
Fact-level verified

After generating the billing code, the applicant must pay the PNBP and upload the payment receipt within at most 7 days; the application is then routed to the PNBP admin for verification before evaluation.

Conditions
  • All applications.

Evaluation timelines are counted from submission of the application to the evaluation team (Bagian B intro).

Special access & derogation

Is an emergency, compassionate, custom, humanitarian, or other exceptional path available?

Compare countries

Emergency use authorization

special.emergency-use-authorization
Fact-level verified

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 devices) or the food-and-drug authority head (for drugs) within their respective mandates.

Conditions
  • Emergency conditions only; device EUA is set by the Minister.

Effective from 2026-05-04

Revocation of an EUA is a recall ground (Pasal 86 huruf f).

Special access scheme (jalur khusus)

special.jalur-khusus-import
Fact-level verified

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 services; research needs; government programmes; social service (bakti sosial); exhibitions; personal use; and other needs determined by the Minister. Personal-use and certain other imports (temporary import, re-import of exports, foreign-representative needs) may proceed without the Minister's approval via courier/postal services, passenger baggage etc.

Conditions
  • Import without izin edar only through this mechanism.
  • Replaced PMK 51/2014 and PMK 7/2020 special access scheme (revoked by PMK 5/2026 Pasal 125 x, mm); certificates are handled via the e-SUKA portal (incl. Research Use Only).

Effective from 2026-05-04

Shortage mitigation may also use jalur khusus and accelerated izin edar (Pasal 96(2)).

Submission communications & appeal

How are deficiencies answered, clocks handled, and decisions escalated or appealed?

Compare countries

Decision communication

comms.decision-notification-and-rejection
Fact-level verified

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 letter electronically via regalkes.kemkes.go.id. Applications failing safety/quality/benefit requirements receive a rejection letter; the paid PNBP fee is not refunded for rejected applications.

Conditions
  • All applications.

Applicant-requested revisions of issued data (e.g. wording corrections) are evaluated and can be approved or rejected by the evaluation team (Bagian C angka 13).

UDI, listing & traceability

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

Compare countries

Public listing registry

listing.public-registry-and-nie-on-label
Fact-level verified

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), which provides a permit-check (Cek Izin) search; the izin edar number (NIE) must appear on the product label.

Conditions
  • All registered products.

Vigilance & incident reporting

What is reportable, by whom, where, in what format, and by what deadline?

Compare countries

Vigilance duty and reporting channel

vigilance.ma-holder-duty
Fact-level verified

The izin edar holder must operate device vigilance ('vigilans': detection, assessment, understanding, communication, control and prevention of adverse effects or other problems related to device use) and report it to the Minister, through the health information system integrated with the national health information system, within deadlines set by the Minister. Health professionals and health facilities may report device adverse events (kejadian tidak diinginkan/KTD) to the Minister; the national reporting channel is the e-Watch Alat Kesehatan system, which also covers field safety corrective actions (FSCA).

Conditions
  • All device classes; deadlines are to be set by ministerial determination under PMK 5/2026.
  • Sanction for failing to conduct vigilance: administrative sanctions (Pasal 117(1)(l)).

Effective from 2026-05-04

e-Watch portal verified: reporting channels 'oleh Fasilitas Pelayanan Kesehatan / Masyarakat Umum' and 'oleh Produsen / Penyalur Alat Kesehatan' (e-watch-alkes.kemkes.go.id). Import applications must already include SOPs for complaint handling, adverse events and recall (PMK 14/2021).

Related structured datasets

Classification systems · 1 record
Open Risk classes A through D. →
Id

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
Open Indonesia registration →
Country

Indonesia

Jurisdiction Id

indonesia

Country Code

ID

Flag

🇮🇩

Regulator

Ministry of Health

Regulator Abbrev

Ministry of Health

Region

asia-pacific

Tier

2

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

No

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
Open Indonesia fees →
Country

Indonesia

Jurisdiction Id

indonesia

Country Code

ID

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
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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