Explore the medical device requirements currently available for Australia, organized by topic and linked to official sources.
Which claims, audiences, channels, approvals, and restrictions apply?
Advertising of therapeutic goods (including medical devices) must comply with the Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021 (F2021L01661), which specifies requirements to protect the public from unethical, inaccurate or misleading advertising practices.
Advertising material for medical devices must be limited to the approved intended purpose under the ARTG inclusion, and it is an offence to advertise a device by any means for any other purpose; the claim 'TGA approved' must not be used in advertising except with explicit TGA authorisation, and restricted representations require prior approval.
What expires, what is retained periodically, and when must renewal start?
ARTG inclusion of a kind of medical device may be cancelled under s 41GL(f) of the Act (or suspended under s 41GA(1)(b)) if the annual charge is not paid within 20 working days of it becoming payable; TGA issues invoices for all non-ACE entries each July, so inclusion is retained by paying annual charges rather than by periodic renewal.
TGA Conformity Assessment certificates are issued for a finite period and expire: manufacturers must apply for recertification of a certificate that is about to expire, lodge new applications for substantial changes, and remain subject to TGA surveillance audits while certified.
Does the event require internal documentation, notice, prior approval, transfer, or a new application?
An ARTG variation is limited to the same kind of device; variations are made under s 9D(1) of the Act and must meet the s 41BE criteria.
Implementing a variation to an ARTG entry before the Secretary has approved it breaches a condition of inclusion in the ARTG.
Which clinical or IVD performance evidence or study is required and accepted?
Clinical evidence is required to substantiate a kind of medical device's compliance with the Essential Principles (Schedule 1 and Part 8 of Schedule 3 of the MD Regulations); clinical evaluation procedures must be applied to the device under reg 3.11(1), and TGA's Clinical evidence guidelines for medical devices set out how to compile and present the evidence.
Is the product a device, IVD, accessory, software, or borderline product locally?
A medical device is defined in s 41BD of the Therapeutic Goods Act 1989; in vitro diagnostic (IVD) devices are medical devices whose definition is set out in the Therapeutic Goods (Medical Devices) Regulations 2002. Software and accessories meeting the definition are regulated as devices.
Which evidence, local deltas, formats, and signatures are required?
Class-specific documents (per Table 2 of TGA's market authorisation evidence guidance) must be attached to the TGA application to pass preliminary assessment
Certificates issued under MRAs may no longer be acceptable for some higher-risk devices including Class III and AIMDs
Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?
Sponsor Or Local Market Entry Owner
Australian sponsor
yes
Owns ARTG Inclusion And Market Entry Obligations
May Be Same But Each Sponsor Needs Own ARTG Entry
Can Be Separate
allowed
A health professional who supplies a device to the Australian market, including by using it in clinical practice, becomes the sponsor of the device.
Sponsor Transfer By Operation Of Law Or New ARTG Inclusion
No If Transfer Notified Yes If No Transfer
Sponsorship changes by operation of law under regs 10AB, 10F and 10H of the Therapeutic Goods Regulations 1990 at the time of the triggering event (death, bankruptcy, winding up, business transfer), regardless of notification
New sponsor must notify TGA as soon as possible after the event; current official guidance states no fee and no fixed statutory window
TGA updates the ARTG entries usually within 10 working days of a complete signed notification
The transfer form cannot be used without the current sponsor's consent; third parties such as manufacturers cannot lawfully transfer sponsorship
Sponsor transfer does not transfer Manufacturer Evidence; the new sponsor must arrange appropriate manufacturer evidence
Correction: the baseline claimed a 3-month notification window; the current official page urges notification as soon as possible and states no 3-month window, no fee, and 10-working-day ARTG update.
The sponsor must meet the definition of sponsor under the Therapeutic Goods Act 1989, which requires a recognised Australian-based legal entity; sponsors are usually the Australian importer of overseas-manufactured medical devices.
Which establishment licences, importer permissions, and distribution controls apply?
Every sponsor must apply to the TGA to have its imported medical devices included in the ARTG, even when another sponsor already has an ARTG entry for the same device; there is no separate importer licence regime — the sponsor's ARTG inclusion authorises import and supply.
What regulator fee applies to this class, route, event, and date?
An audit fee must be paid only when an application is selected for mandatory audit by law; no audit fee is payable when an application is selected for non-mandatory audit, and the audit cannot start until fees are paid.
Which label and IFU elements, languages, symbols, and translation controls apply?
Device information may be supplied in multiple languages, but if the device is supplied in Australia one of those languages must be English; information supplied with the device must be clear, legible and provided in English. Labelling content requirements are in Essential Principle 13 (Schedule 1, MD Regulations) and the sponsor's name and address must appear on supplied devices under Regulation 10.2.
Which current law, regulation, guidance, and transition provisions apply?
Therapeutic Goods Act 1989 (Commonwealth) is the primary legislation: medical devices are defined in s 41BD, and ARTG inclusion, conformity assessment certification, suspension/cancellation and s 60 reconsideration all sit under this Act, supported by the Therapeutic Goods (Medical Devices) Regulations 2002.
Which PMS plan, report, PMCF or PMPF, trend, and lifecycle-update duties apply?
Sponsors must provide annual reports for the first three years where a Class III, Class IIb implantable, or Class 4 IVD device is included in the ARTG (s 41FO(2) of the Act; reg 5.11 of the MD Regulations).
Records must be retained for 10 years for Class 4 IVDs, Class III and Class IIb implantable devices, or 5 years for other devices, after the last product has been distributed (s 41FO of the Act; regs 5.9, 5.10 and 8.1(b) of the MD Regulations).
Which current form, portal, account, and submission package must be used?
Applications for ARTG inclusion are lodged through the TGA Business Services (TBS) portal; the sponsor needs a Client ID and TBS access before submitting a medical device application.
Which QMS, audit, inspection, and certificate scope is accepted or required?
Regulatory Qms Aligned With Iso
TGA audits the manufacturer's QMS as part of Conformity Assessment against regulatory requirements and ISO 13485:2016, with on-site or desktop assessments; surveillance audits continue after certificate issue
ISO 13485 certificates alone do not create ARTG inclusion; evidence of audits by comparable overseas regulators or MDSAP auditing organisations may support an abridged desktop assessment
Rac Member Audit Reuse
Which recall, FSCA, notice, and authority-coordination duties apply?
The Procedure for Recalls, Product Alerts and Product Corrections (PRAC) took effect on 5 March 2025 and replaced the Uniform Recall Procedure for Therapeutic Goods (URPTG); recall notifications are lodged via TGA Business Services, TGA aims to agree notifications within 7 business days, and actions are classified Class I/II/III with wholesale, hospital, retail and consumer levels, published in the DRAC database.
Effective from 2025-03-05
Corrects the brief's hint that URPTG still applies.
Which registration, notification, listing, reliance, or conformity route applies?
Manufacturer's Evidence must be submitted to and accepted by TGA before the sponsor commences the device inclusion application; documents attached to the application are assessed in addition to that evidence.
Unless exempt, a device must be included in the Australian Register of Therapeutic Goods (ARTG) before supply: the Australian sponsor lodges an inclusion application via TGA Business Services after acceptable Manufacturer's Evidence is in place, and TGA performs a 20-working-day preliminary assessment plus any mandatory or discretionary audit before inclusion.
Which foreign decisions or evidence can be reused, with what effect and conditions?
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.
Prior approval / evidence record
A device that has no Armenian state registration can still be imported, but the import (conformity) certificate file must contain a document confirming that the device is authorised for use — state registration or free circulation — in its country of manufacture or in an IMDRF member country, or a reasoned reference to such a document, including a Declaration of Conformity with references to the relevant registers. This is the origin-country free-sale certificate requirement: a Turkish, Korean, Chinese or European exporter must produce its home-country registration/free-sale evidence (or an IMDRF-country equivalent) even though the device is not registered in Armenia. The document is mandatory paperwork; the Armenian expert organisation still examines the file and the Ministry of Health still decides.
Registration / free circulation in the country of manufacture, or in any IMDRF member country — US FDA, EU member states (CE), Japan PMDA, Korea MFDS, China NMPA, Canada, Australia, Brazil, Singapore, UK — evidenced by a registration certificate, free-sale certificate or a Declaration of Conformity with register references
Origin Country Evidence
Evidence Only
Import Control
Yes
Yes
Language: Armenian. Verbatim, Government Decree No. 429-Ն of 30.03.2023, Annex No. 2, para. 2(2)(a): "պետական գրանցում չունեցող բժշկական արտադրատեսակների համար՝ ա. բժշկական արտադրատեսակի արտադրող երկրում կամ Բժշկական արտադրատեսակների կարգավորող մարմինների միջազգային համաժողովի (IMDRF) անդամ երկրներում կիրառման թույլտվությունը (պետական գրանցումը, ազատ կիրառումը) հավաստող փաստաթուղթ կամ դրա վերաբերյալ փաստարկված տեղեկանք, այդ թվում՝ բժշկական արտադրատեսակների համապատասխանության հայտարարագիր (Declaration of Conformity) համապատասխան գրանցամատյանների հղումով". Translation: "for medical devices without state registration: a. a document confirming authorisation for use (state registration, free circulation) in the country of manufacture of the medical device or in member countries of the International Medical Device Regulators Forum (IMDRF), or a reasoned reference thereto, including a Declaration of Conformity for the medical device with reference to the relevant registers".
Prior approval / evidence record
Armenia registers medical devices under two national procedures: a general procedure and a simplified procedure. The simplified procedure applies to a device that is registered in a country that is a member of the International Medical Device Regulators Forum (IMDRF) or that is prequalified by the World Health Organization. IMDRF members include the United States (FDA), the EU member states (CE marking), Japan (PMDA), Korea (MFDS), China (NMPA), Canada, Australia, Brazil, Singapore and the United Kingdom, so a US FDA 510(k)/PMA clearance, an EU CE mark, a Japan PMDA approval and a Korea MFDS approval all satisfy the gate. The device is still registered in Armenia by the Armenian authority — the foreign registration opens the shortened procedure, it does not replace the Armenian certificate.
Registration in any IMDRF member country — US FDA 510(k)/PMA, EU CE marking under MDR/IVDR (any EU member state), Japan PMDA, Korea MFDS, China NMPA, Health Canada, Australia TGA, Brazil ANVISA, Singapore HSA, UK MHRA — or WHO prequalification of the device
Abridged Or Recognition Route
facilitated
Premarket Review
Yes
Yes
Language: Armenian. Verbatim, Article 46(4): "Սույն հոդվածի 3-րդ մասով սահմանված կարգի համաձայն՝ բժշկական արտադրատեսակները գրանցվում են ընդհանուր և պարզեցված ընթացակարգերով: Պարզեցված ընթացակարգը կիրառվում է բժշկական արտադրատեսակների շրջանառությունը կարգավորող մարմինների միջազգային համաժողովի (IMDRF) անդամ երկրում գրանցված կամ Առողջապահության համաշխարհային կազմակերպության նախաորակավորած բժշկական արտադրատեսակների համար:" Translation: "Under the procedure laid down by part 3 of this article, medical devices are registered under general and simplified procedures. The simplified procedure applies to medical devices registered in a member country of the International Medical Device Regulators Forum (IMDRF) or prequalified by the World Health Organization." Article 46 was amended by the Law of 5 December 2024 ՀՕ-502-Ն; the consolidated expression is the version in force from 31.05.2026.
Prior approval / evidence record
Registration certificate from SFDA (Saudi Arabia), US FDA, TGA (Australia), PMDA (Japan), MHRA (United Kingdom), HPRA (Ireland), Swissmedic (Switzerland), ANSM (France) or BfArM (Germany)
Yes
Article (7) bis of Resolution No. (48) of 2020, inserted by Resolution No. (69) of 2024, provides by way of exception to the ordinary Article (7) prohibition that medical devices and products registered in one of the nine listed reference countries 'shall also be registered in the Kingdom of Bahrain' on the basis of that country's registration certificate, on payment of the applicable fee. This is a documentary registration route rather than a full de novo technical assessment, but the application is still filed by a licensed Bahraini Authorized Representative and NHRA retains the decision.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
Article (7) bis of Resolution No. (48) of 2020, inserted by Resolution No. (69) of 2024, provides that by way of exception to the ordinary Article (7) prohibition, medical devices and products registered in one of nine listed reference countries 'shall also be registered in the Kingdom of Bahrain' on the basis of the registration certificate issued by that country, following payment of the applicable fee. The listed reference authorities are SFDA (Saudi Arabia), FDA (United States), TGA (Australia), PMDA (Japan), MHRA (United Kingdom), HPRA (Ireland), Swissmedic (Switzerland), ANSM (France) and BfArM (Germany). A holder of a US FDA or Japan PMDA registration therefore has a documentary registration route in Bahrain rather than a full de novo technical assessment.
US FDA registration/clearance; Japan PMDA approval; Saudi SFDA registration; Australia TGA registration; UK MHRA registration; Ireland HPRA registration; Swissmedic (Switzerland) registration; France ANSM registration; Germany BfArM registration
Abridged Or Recognition Route
facilitated
Product Marketing
Yes
Yes
Effective from 2024-11-22
Verbatim source passage: "By way of exception to Article (7) of this Resolution, medical devices and products registered in one of the following reference countries shall also be registered in the Kingdom of Bahrain: 1. Kingdom of Saudi Arabia - Represented by the Saudi Food and Drug Authority (SFDA). 2. United States of America - Represented by the Food and Drug Administration (FDA). 3. Australia - Represented by the Therapeutic Goods Administration (TGA). 4. Japan - Represented by the Pharmaceuticals and Medical Devices Agency (PMDA). 5. United Kingdom - Represented by the Medicines and Healthcare products Regulatory Agency (MHRA). 6. Ireland - Represented by the Health Products Regulatory Authority (HPRA). 7. Switzerland - Represented by Swissmedic(Swissmedic). 8. France - Represented by the French National Agency for Medicines and Health Products Safety (ANSM). 9. Germany - Represented by the Federal Institute for Drugs and Medical Devices (BfArM). Based on the registration certificate issued by one of these countries, following the payment of the applicable fee."
Prior approval / evidence record
At renewal, Bahrain requires a Free Sale Certificate (FSC) or Certificate to Foreign Government issued by the regulatory authority of the country of origin or of a reference country (Registration Guideline 9.1, section 10 item 4). The guideline's glossary (item 14) defines reference countries as Saudi Arabia, USA, UK, Australia, Canada, Japan, Switzerland, Ireland, Denmark, New Zealand, France, Holland and Belgium, so a certificate from one of those authorities substitutes for an origin-country free-sale certificate. A Free Sale Certificate is also required on manufacturer acquisition (section 12).
Free Sale Certificate or Certificate to Foreign Government from the country of origin or from a reference country (Saudi Arabia, USA, UK, Australia, Canada, Japan, Switzerland, Ireland, Denmark, New Zealand, France, Holland, Belgium)
Origin Country Evidence
Evidence Only
Premarket Review
Yes
Yes
Verbatim source passages: "Free Sale Certificate (FSC) or Certificate to foreign government issued by the regulatory authority of the country of origin or a reference country." and "Reference countries: Saudi Arabia, USA, UK, Australia, Canada, Japan, Switzerland, Ireland, Denmark, New Zealand, France, Holland, Belgium."
Prior approval / evidence record
To obtain an NHRA classification letter, the applicant must supply a Free Sale Certificate or Registration Certificate issued by the competent authority of the country of origin or by one of the reference countries listed in the classification guideline (SFDA, USA, UK, Australia, Canada, Japan, Switzerland, Ireland, Denmark, New Zealand, France, Holland, Belgium), together with a recognised quality assurance certificate such as ISO 13485, CE mark or FDA.
Registration certificate or Free Sale Certificate from SFDA (Saudi Arabia), US FDA, UK, Australia, Canada, Japan, Switzerland, Ireland, Denmark, New Zealand, France, Holland or Belgium
Origin Country Evidence
Evidence Only
classification
Yes
Yes
Verbatim source passage: "1. Free Sale Certificate OR Registration Certificate issued from competent authority in country of origin classifies the product as a medical device. 2. Free Sale Certificate OR Registration Certificate issued from one of the following reference countries: (SFDA, USA, UK, Australia, Canada, Japan, Switzerland, Ireland, Denmark, Newzland, France, and Holland, Belgium.)."
Regulatory reference
Dossier must include regulatory status evidence: for Class C and D devices a Free Sale Certificate from any one of EU, USA, Canada, Australia and Japan plus an FSC from the country of origin; a conformity-assessment certificate or equivalent must also be submitted. (Class B: FSC from country of origin.)
Guideline s.4.7 accepts QMS/product certification or marketing authorization issued by a National Regulatory Authority/notified body outside Bangladesh; a Device Master File is required only where CE/US FDA approvals are not available.
Prior approval / evidence record
The Medicines and Related Substances Act, 2025 introduces reliance on decisions by trusted authorities and mutual recognition agreements, and the draft Medical Devices Regulations, 2026 would let BoMRA rely on approvals from IMDRF member authorities, African Medical Devices Forum recognised authorities, WHO prequalification, WHO Listed Authorities and Maturity Level 3/4 authorities, and on MDSAP audit outcomes. Neither instrument is in force: the Act's commencement is 'ON NOTICE' and the Regulations are unpublished drafts. A holder of a foreign approval therefore has no route under these provisions today.
none
No Reliance Route
none
Premarket Review
Yes
Yes
Status is official-source-verified for the text of the draft; the conditions and the reliance-recognition value record that the instrument is not in force. This is the deliberate 'do not upgrade a policy aspiration into an operating route' fact for Botswana. The draft would also give registration a five-year term (draft reg. 20(1)).
Prior approval / evidence record
Stringent Regulatory Authority approval — ICH members (European Commission, US FDA, Japan MHLW/PMDA), ICH observers (Swissmedic, Health Canada) or an authority associated with an ICH member through a legally binding mutual recognition agreement (including Australia, Iceland, Liechtenstein and Norway)
No
The SRA definition in G01 s.3.1.26 is used for dossier and reference purposes rather than as an automatic grant: an SRA approval does not by itself confer a Botswana registration, and it benefits the applicant only through the abridged pathway's proof-of-reference-agency requirement, which is defined by the separate Reference Regulatory Authority concept.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
For a Class B, C or D general medical device, an existing approval from a Stringent Regulatory Authority, a BoMRA-recognised Reference Regulatory Authority, or WHO prequalification, together with a valid ISO 13485 certificate, qualifies the application for the abridged assessment pathway instead of full evaluation. Class B accepts one approval from an RRA, an SRA or WHO. Class C requires at least one SRA or WHO approval, plus at least three years on the market in an SRA jurisdiction and no safety issues in the previous three years. Class D requires approvals from at least two RRAs including one SRA, plus the same three-year marketing and safety conditions. The local application and the final BoMRA decision are retained in all cases.
Any Stringent Regulatory Authority (ICH member: European Commission, US FDA, Japan MHLW/PMDA; ICH observers: EFTA/Swissmedic, Health Canada; ICH-associated via MRA: Australia, Iceland, Liechtenstein, Norway) or a BoMRA-recognised Reference Regulatory Authority, or WHO (with valid ISO 13485 certification or equivalent)
Abridged Or Recognition Route
facilitated
Premarket Review
Yes
Yes
Effective from 2024-12-09
SRA is defined in the same guideline at s. 3.1.26 as an ICH member (European Commission, US FDA, MHLW/PMDA), an ICH observer (EFTA as represented by Swissmedic, and Health Canada), or an authority associated with an ICH member through a legally binding mutual recognition agreement (Australia, Iceland, Liechtenstein, Norway). China NMPA is NOT an SRA on that definition. RRA is defined at s. 3.1.25 by cross-reference to BoMRA policy 'Recognition and-or Reliance on Information on Medical Devices including IVDs from Regional and International Regulatory Agencies BOMRA-ER-MED-Policy No.1', which was not found published on the BoMRA site.
Regulatory reference
Australia Therapeutic Goods Administration (TGA) listing on the Australian Register of Therapeutic Goods (ARTG) is accepted under the optimized review procedure for class III/IV device registration.
Effective from 2024-06-03
Framework: RDC 741/2022 (in force 1 September 2022) + IN 290/2024 (in force 3 June 2024).
Prior approval / evidence record
Optimized analysis (procedimento otimizado, IN 290/2024)
ANVISA uses the analysis already performed by a recognised equivalent foreign regulator as the sole or complementary reference for the registration decision. It shortens how much ANVISA has to re-review, not where the petition sits in the queue: Art. 10 states expressly that adopting the optimized procedure does not change the chronological order of petitions, and ANVISA publishes no reduced deadline for it.
No published reduction — the RDC 743/2022 deadlines still apply and Art. 10 preserves queue position
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
TGA (Australia)
Yes
Recognised AREE for IN 290/2024, evidenced by the ARTG entry
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
In at least one Ministry of Health procurement, equipment must comply with one of five named international safety standards — US FDA Standard, European Union CE MARK, Australian TGA Standard, Canadian CSA Standard or Japanese Standard. This is a tender technical requirement for the supply of equipment, not a market-authorisation recognition rule: it creates no registration pathway, shortens no review, and does not name Japan PMDA, Korea MFDS or China NMPA.
US FDA standard; EU CE Marking; Australian TGA standard; Canadian CSA standard; Japanese standard (named generically, not as PMDA approval)
Procurement Admission
Evidence Only
procurement
No
No
Verbatim from the tender document (44 pages, text layer, retrieved HTTP 200, 629,727 bytes): 'The equipment must comply to either one of the five international safety standards namely; US FDA Standard, European Union CE MARK, Australian TGA Standard, Canadian CSA Standard or Japanese Standard. The equipment must also comply with relevant AAMI Standards such as UL2601 and IEC601-1.' Searches of the document for 'PMDA', 'MFDS', 'NMPA', 'Korea' and 'China' return no matches, which is why the sourceApproval string does not name those authorities. The bounded claim recorded in value is deliberately limited to what this one procurement states.
Regulatory reference
Health Canada maintains a List of Regulatory Agencies (around 40 authorities including US FDA, ANVISA, TGA, MHRA, PMDA/MHLW, COFEPRIS, MFDS, HSA, Swissmedic and NMPA) incorporated by reference into MDR ss.61.2 and 68.3; decisions of these agencies trigger Canada's 72-hour foreign risk notification duty.
Page issued 2024-01-03, modified 2024-01-24.
Prior approval / evidence record
class-iia
Class IIa
medium
Registration (NSO)
2
2
working-days
official-verified
Decreto 4725 de 2005 — INVIMA statutory review clocks (Arts. 21-22)
https://normograma.invima.gov.co/normograma/compilacion/docs/decreto_4725_2005.htm
2026-08-25
1
2
months
2
3
months
No
No
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
class-iib
Class IIb
high
Registration (RSO)
90
90
working-days
official-verified
Decreto 4725 de 2005 — INVIMA statutory review clocks (Arts. 21-22)
https://normograma.invima.gov.co/normograma/compilacion/docs/decreto_4725_2005.htm
2026-08-25
6
12
months
4
6
months
No
No
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Regulatory reference
For imported devices, a certificate from the competent authority of the country of origin stating the product is authorized for production or marketing there is required; if the product is not used in the country of origin, a free-sale certificate from a reference country (EU, United States, Canada, Japan, Australia) or a country with a mutual recognition agreement is required instead.
Prior approval / evidence record
Homologación for reference countries (Decreto 3275/2009)
Colombia does not run a separate reliance queue. What a reference-country approval buys is the right to skip specific numerals of the Formato Único: for Class I and IIa the technical studies and analytical checks, the sterilisation method and the disposal method; for Class IIb those three plus the clinical studies. Class III is outside the homologation and has to file all twenty numerals.
None — the Decreto 4725/2005 clocks are unchanged; the saving is in dossier assembly
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
Australia TGA
Yes
Reference-country origin under Decreto 3275/2009
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Regulatory reference
Per Article 47 of the Reglamento (acápite 3.2.4), devices with prior registration in their country of origin or in another country with a device regulatory program based on the same essential safety/efficacy requirements as the Cuban program (such as IMDRF members) are exempt from presenting: software validation report, biological pre-clinical evidence, safety/environmental/parametric test reports, raw-material certificates of analysis, and stability study. In lieu they present the Certificate of Registration of the origin country or an internationally recognized regulatory program; where the device circulates under manufacturer responsibility without registration, a manufacturer declaration plus evidence of circulation suffices.
Effective from 2016-07-29
Reinforced by E 132-25 epígrafe 3.8: the CECMED will, as appropriate, take into account decisions of other regulatory authorities and regional/international bodies.
Prior approval / evidence record
WHO Strict Authorities — US FDA, Health Canada, Japan NIHS, Australia TGA, EMA, Icelandic Medicines Agency, Norwegian Medicines Agency, Liechtenstein AML
Yes
Eligibility for the simplified registration procedure under Resolución No. 000004 on a Certificate of Free Sale plus a good-manufacturing-practices certificate from that authority, for new registrations and renewals of imported products; the remaining legal requirements still apply and DIGEMAPS retains the decision.
No published period: the MSP service listing shows 'Inmediatamente' rather than a number of days.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
An imported product that has previously been authorised by a WHO Strict Authority or by a regional reference regulatory authority (ARNr) of the PAHO/PARF network may be registered through the simplified procedure, evidenced by a Certificate of Free Sale and a Certificate of Good Manufacturing Practices issued by that authority, in addition to the other requirements of current legislation. Products that any of those authorities has refused to authorise are excluded from the simplified procedure.
WHO Strict Authorities: US FDA; Health Canada; Japan NIHS (National Institute of Health Science); Australia TGA; EMA; Icelandic Medicines Agency; Norwegian Medicines Agency; Liechtenstein (Amt für Lebensmittelkontrolle und Veterinärwesen). PAHO/PARF regional reference authorities (ARNr): ANMAT (Argentina), ANVISA (Brazil), CECMED (Cuba), INVIMA (Colombia), COFEPRIS (Mexico)
Abridged Or Recognition Route
facilitated
Premarket Review
Yes
Yes
Effective from 2016-04-01
Spanish. Source PDF is an image-only scan (Adobe 'Image Conversion Plug-in'); the passage below was read from the scan by OCR and OCR spacing artefacts were normalised. Original: "Productos importados que previamente hayan sido autorizados por Autoridades Estrictas (OMS) y/o de Autoridades Reguladoras de Referencia Regional (ARNr) de la Red Panamericana para la Armonización de la Reglamentación Farmacéutica (RED PARF/OPS), lo cual debe ser avalado mediante la presentación del 1. Certificado de Libre Venta y Certificado de Buenas Prácticas de Manufactura emitido por las referidas autoridades en adición a los demás requisitos establecidos en la legislación vigente." English: imported products previously authorised by WHO Strict Authorities and/or PAHO/PARF regional reference authorities, evidenced by the free-sale and GMP certificates issued by those authorities, in addition to the other requirements of current legislation. The recognised-authority list (TERCERO) names FDA, Health Canada, NIHS, TGA, EMA, the Icelandic and Norwegian medicines agencies and Liechtenstein as Strict Authorities, and ANMAT, ANVISA, CECMED, INVIMA and COFEPRIS as ARNr.
Regulatory reference
From 28 January 2027, the simplified procedure requires registration from an authority that satisfies BOTH high-vigilance status and IMDRF membership (Article 31). Article 32 additionally requires device marketing in an IMDRF Management Committee country, device-scope authorisation and ARCSA risk classification I-IV. IMDRF membership alone is not sufficient, and NMPA eligibility is not established by this general rule.
Effective from 2027-01-28
Recognition opens a simplified procedure; it is not a full reliance approval.
Regulatory reference
For imported devices, a Certificate of Free Sale (CLV) or equivalent is accepted from the country of manufacture or export, from a high-vigilance agency, or from an IMDRF member country; if the CLV or the product-owner authorization states no validity date, ARCSA considers it valid for a maximum of two years from issuance. Electronic CLVs are accepted without apostille when verifiable on the issuing authority's website.
Effective from 2027-01-28
Current regime already requires a CLV/Certificate of Exportation for imports (2016 Art. 16.a).
Regulatory reference
EDA recognizes reference countries: EU member states plus Australia, Canada, Iceland, Ireland, Japan, New Zealand, Norway, Switzerland, United Kingdom and United States of America; devices from these countries get reduced documentation, while devices from non-reference countries need extra evidence.
Variation guideline v03 (res-eg-variations) lists the same set plus Croatia and Liechtenstein.
Prior approval / evidence record
A medical device that already holds a marketing authorisation, registration certificate or free-sale certificate from one of the authorities EFDA lists as a Stringent Regulatory Authority can be filed on the SRA route (EFDA/GDL/046 §9.4). The applicant still submits the complete administrative and technical dossier required by the ordinary registration guidelines, but EFDA reviews it as a verification exercise focused on the genuineness of the submitted information rather than a de-novo assessment, so the application takes shorter processing time. EFDA keeps the right to conduct a full assessment and to request further information whenever it deems necessary.
US FDA marketing authorisation / registration certificate / free-sale certificate; Japan MHLW; Australia TGA; Singapore HSA; a competent authority of one of the 27 EU Member States (Directive 93/42/EEC, Directive 98/79/EC, MDR 745/2017, IVDR 746/2017); UK MHRA; Health Canada; South Korea MFDS
Abridged Or Recognition Route
facilitated
Premarket Review
Yes
Yes
Effective from 2026-06-25
Verbatim: 'At present, EFDA accepts the registration submissions as an SRA or prequalified products application if they're supported by one or more of the following document(s). 1. A Marketing Authorization certificate or registration certificate or free sale certificate issued by one of the following competent national regulatory authority: US Food and Drug Administration; Ministry of Health, Labour and Welfare, Japan; Trapeutic Goods Administration, Australia; Health Science Authority, Singapore; Competent Authorities from one of the 27 Member States of the European Union who are responsible in Europe for the oversight of Directive 93/42/EEC, Directive 98/79/EC, MDR 745/2017, IVDR 746/2017.; Medicine and Healthcare Products Regulatory Agency, UK; Health Canada, Canada; Ministry of Food and Drug Safety, South Korea'. The passage also states: 'The applicants should submit all documentation required for registration of medical devices through full assessment path way, but it takes shorter processing time as it will focus on verifiying genuinness of submitted information.' Typographical errors are reproduced as they appear in the source.
Prior approval / evidence record
Australia TGA
Yes
ARTG certificate satisfies D002
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Regulatory reference
Pathway 2 accepts marketing approval documents from eight recognised jurisdictions (Chinese Mainland NMPA, USA FDA, EU, Canada, Japan, Singapore, South Korea MFDS, Australia TGA); for example the USA accepts 510(k), PMA or De Novo, and all model/code variants must be covered by the certificate.
A valid Certificate of Free Sale may be requested; certificates must remain valid during assessment (GN-02 clause 8.1).
Prior approval / evidence record
class-a
Class A
low
Registration
45
45
days
official-verified
CDSCO Medical Devices Rules, 2017 (G.S.R. 78(E))
https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2022/m_device/Medical%20Devices%20Rules%2C%202017.pdf
2026-08-25
6
9
months
3
5
months
No
Yes
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Regulatory reference
Where a free sale certificate has been issued by the national regulatory authority of Australia, Canada, Japan, an EU country, the United Kingdom or the United States, the import licence is granted without carrying out clinical investigation.
Effective from 2018-01-01
G.S.R. 174(E): for the words 'or the United States of America' the words 'United Kingdom or the United States of America' shall be substituted.
Prior approval / evidence record
Australia TGA
Yes
Named in Rule 36(3) and in the Rule 63(1) proviso, so both the clinical investigation waiver and the no-predicate relief are available.
None published — the saving is the clinical investigation, not the clock
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Regulatory reference
A device registered, or approved for marketing and actually marketed, in a 'recognized state' (מדינה מוכרת) is registered in the Israeli register for a period not exceeding the period it may be marketed in that state, capped at 5 years from Israeli registration. Recognized states are listed in the First Addendum to the law — 21 states including the US, UK, Germany, France, Italy, Spain, the Netherlands, Belgium, Ireland, Denmark, Sweden, Finland, Norway, Iceland, Greece, Portugal, Austria, Switzerland, Australia, Canada and New Zealand (no single 'EU' entry: member states are listed individually).
First Addendum list per the official Sefer HaChukim text of the law held from gov.il.
Regulatory reference
Health Canada medical device licences are among the accepted reference approvals for AMAR registration (listed in the official registration guidelines alongside FDA, CE and TGA); Canadian registrations in principle have no expiry, so a validity of 5 years from the submission date is entered in the approvals table when filing.
Health Canada listed as accepted approval per the AMAR registration guidelines PDF.
Prior approval / evidence record
Health Canada or Australia TGA
Yes
REG-2024/06 restricts the regulatory certificate types that can be entered on an application to CE, FDA, FDA K510, Australian Ministry of Health and Canadian Ministry of Health, so a Canadian or Australian approval is a first-class reference certificate on the same terms as a US or EU one.
Same track placement as the US and EU certificates above
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Regulatory reference
Australian and Canadian registrations in principle have no expiry; when filing (fast track), a validity of 5 years from the submission date is entered in the approvals table. TGA approvals are accepted only of the REGISTRATION type (not ARTG listing types other than registration).
TGA REGISTRATION-only condition per the AMAR registration guidelines PDF.
Regulatory reference
PPB's Guidelines on Reliance Mechanisms for Marketing Authorization apply to all health products and technologies including medical devices: PPB may base part or all of its regulatory decisions on prior evaluations conducted by trusted reference authorities while retaining authority for final approval. Eligible reference mechanisms listed include WHO Prequalification Programme / Collaborative Registration Procedure, Stringent Regulatory Authorities (US FDA, EMA, Health Canada, Swissmedic, PMDA Japan, TGA Australia) and the East African Community Medicines Regulatory Harmonization (EAC-MRH).
Regulatory reference
The medical device registration guideline recognizes marketing clearances from eight listed reference regulatory agencies: Australia TGA, Health Canada, EU Notified Bodies (MDD/AIMDD/IVD Directive certificates), Japan MHLW, US FDA (510(k) or PMA), Ireland HPRA, Saudi Arabia SFDA and Swissmedic. US FDA 510(k)-exempt products do not qualify for the abridged route. Approvals from EU and TGA count as independent reference approvals only if the devices were reviewed and approved by those agencies themselves and not registered on the basis of a Mutual Recognition Agreement (MRA).
Prior approval / evidence record
Health Canada, Japan MHLW/PMDA, UK MHRA, Brazil ANVISA and Australia TGA approvals
Yes
Also recognised reference authorities under the Abridged Review Pathway, on the same terms as the FDA and EU routes: identical product required, national requirements still assessed, final acceptance decided by the Administration.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
The Lebanese assessment of an implantable device does not address the clinical-evaluation aspects at all: the MOPH health technology unit explicitly relies on the work already carried out by the regulatory authorities of the GHTF countries. A device whose clinical evidence was assessed by the FDA, an EU notified body, Health Canada, the TGA or Japan therefore does not have that clinical evidence re-reviewed in Lebanon.
Regulatory authorities of the GHTF countries (US FDA, EU member states, Health Canada, Australia TGA, Japan MHLW/PMDA)
Assessment Report Reliance
facilitated
Premarket Review
Yes
Yes
Effective from 2013-11-01
Source language French. Original: "Les aspects relatifs à l'évaluation clinique ne seront pas abordés en faveur d'une exploitation des travaux déjà effectués par les autorités réglementaires dans les pays de la GHTF." Translation: "The aspects relating to clinical evaluation will not be addressed, in favour of making use of the work already done by the regulatory authorities in the GHTF countries."
Prior approval / evidence record
To obtain authorisation to place a medical device on the Lebanese market the device must conform to at least one of the regulations in force in Canada, Australia, Japan, the United States or an EU member state. An FDA, CE, Health Canada, TGA or Japan approval is therefore the conformity basis on which the Lebanese file is admitted rather than a starting point for a fresh assessment. The device must in addition satisfy Lebanese standards where such standards exist.
US FDA 510(k)/PMA; EU CE marking (notified-body certificate plus manufacturer declaration of conformity); Health Canada; Australia TGA; Japan MHLW/PMDA
Abridged Or Recognition Route
facilitated
Premarket Review
Yes
Yes
Effective from 2013-11-01
Source language French. Original: "Pour obtenir l'autorisation de mise sur le marché libanais, le dispositif médical doit être conforme à au moins une des réglementations en vigueur dans les pays suivants: Canada, Australie, Japon, Etats Unies, pays membres de l'union européenne. Le dispositif médical doit, par ailleurs, satisfaire les exigences des normes libanaises quand elles existent." Translation: "To obtain authorisation to place on the Lebanese market, the medical device must conform to at least one of the regulations in force in the following countries: Canada, Australia, Japan, United States, member states of the European Union. The medical device must, moreover, satisfy the requirements of Lebanese standards where they exist."
Prior approval / evidence record
A registration application must be accompanied by at least one of a closed menu of conformity documents: the US FDA approval (510(k) or PMA) or an FDA certificate for foreign governments; a CE marking certificate issued by a notified body plus the manufacturer's declaration of conformity; a safety certificate issued by a competent authority of Australia, Canada or Japan or other IMDRF countries; a certificate of conformity to Lebanese standards issued by the Industrial Research Institute; or — for products originating outside the EU, USA, Canada, Australia and Japan — an ISO 13485 quality-system certificate. A manufacturer's authorisation for the local distributor is required in all cases.
US FDA 510(k)/PMA and FDA certificate for foreign governments; EU CE marking certificate plus declaration of conformity; safety certificates of Australia TGA, Health Canada, Japan and other IMDRF member authorities; Lebanese IRI certificate
Abridged Or Recognition Route
facilitated
Premarket Review
Yes
Yes
Effective from 2013-11-01
Source language French. The excerpt is the contiguous run at the head of the list; the list continues on the next page, past a running header, with the CE and IMDRF bullets, quoted here separately: "o Certificat de marquage CE délivré par un organisme notifié (nom et numéro de l'organisme notifié doivent figurer d'une façon claire) ainsi que la déclaration de conformité faite par le fabricant. o Certificat garantissant la sécurité du dispositif délivré par l'une des autorités compétentes des pays suivants: Australie, Canada ou Japon et autres pays de l'IMDRF. o Certificat de conformité aux normes libanaises délivré par l'institut de recherche industriel (IRI) le cas échéant." Translation of the excerpt: "The registration application must be accompanied by at least one of the following documents: the approval of the US FDA administration (510(k) or PMA certificate); a US FDA certificate for foreign governments." Translation of the continuation: "a CE marking certificate issued by a notified body (notified body name and number must appear clearly) together with the declaration of conformity made by the manufacturer; a certificate guaranteeing the safety of the device issued by one of the competent authorities of the following countries: Australia, Canada or Japan and other IMDRF countries; a certificate of conformity to Lebanese standards issued by the industrial research institute (IRI), where applicable."
Prior approval / evidence record
GHTF/IMDRF member countries — free-sale certificate (شهادة بيع حر)
Yes
A mandatory document rather than a route: Decision 1506/1 Art. Four requires the registration application to carry a free-sale certificate issued by a country belonging to the GHTF/IMDRF group, meaning the device is sold in one of those countries whatever its origin, and the Ministry's service records require a free-sale certificate with an ISO 13485 certificate where the goods are made outside the reference states or the listed documents cannot be produced. No examination period is shortened by it.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
In addition to the documents required by Article Six of Decision No. 455/1 of 16 April 2013, a registration application must be accompanied by a free sale certificate or a certificate for foreign government issued by one of the countries belonging to the IMDRF (International Medical Devices Regulators Forum) — that is, proof that the device is sold in one of those countries, whatever its origin. This is a separate and mandatory documentary condition, not a route to a shortened review. (Decision No. 1506/1 of 1 September 2014, Article Four.)
Free sale certificate or certificate for foreign government issued by an IMDRF member country (the decision names the IMDRF group rather than individual authorities)
Origin Country Evidence
Evidence Only
Premarket Review
Yes
Yes
Effective from 2014-02-18
Source language Arabic; the PDF is a scan with no text layer and the text was recovered by OCR (pdftoppm -r 300 -png + tesseract -l ara+eng), so the wording is an OCR reading and Arabic-Indic digits are unreliable — hence source-backed-partial. OCR original: "إضافة الى المستندات المطلوبة في المادة السادسة من القرار رقم 1/455 تاريخ 2013/4/16، يرفق بطلب التسجيل شهادة بيع حر Free sale certificate أو certificate for foreign government صادرة عن احدى الدول المنتمية الى مجموعة IMDRF (International Medical Devices Regulators Forum) اي انها تباع في واحدة من هذه الدول مهما كان منشؤها." Translation: "In addition to the documents required under Article Six of Decision No. 455/1 of 16/4/2013, the registration application shall be accompanied by a free sale certificate or a certificate for foreign government issued by one of the countries belonging to the IMDRF (International Medical Devices Regulators Forum); that is, that it is sold in one of these countries, whatever its origin." The article number (المادة الرابعة, Article Four) is legible in the OCR.
Prior approval / evidence record
US FDA (510(k)/PMA approval or approval letter), European Union (conformity certificate issued by the manufacturer and by EU-notified bodies), Swiss, Australian, Canadian or Japanese competent health authorities (conformity certificate)
Yes
Accepted and in practice required for an implantable device: Decision 455/1 Art. Six lists them as the conformity documents that go into the registration file — a European-standards certificate from the manufacturer and EU-notified bodies, an FDA marketing approval or approval letter, or a conformity certificate from the health authorities of Switzerland, Australia, Canada or Japan — and Decision 1506/1 Art. Four requires a GHTF/IMDRF free-sale certificate on top. The Ministry's service records for sterile instruments and laboratory reagents require FDA evidence for US-origin goods and CE evidence for European ones. The benefit is documentary, not a shortened clock: none of the instruments publishes an abbreviated examination period, and the registration certificate is still issued on the Health Technology Unit's advice to the Minister.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Regulatory reference
Special-access-type authorisations are not eligible for the verification route, including US FDA EUA / Expanded Access / HDE, EU exceptional use authorisations, UK MHRA exceptional use, Health Canada SAP / Interim Orders, Japan compassionate use and emergency regulatory pathway, TGA SAS / Authorised Prescriber / emergency exemptions, HSA Special Access Routes, and Thai FDA section 27 non-commercial exemptions.
Prior approval / evidence record
class-b
Class B
medium
Registration
30
30
working-days
official-verified
MDA/GD/0070 — registration submission guide, cl. 6.4 turnaround
https://www.mda.gov.my/index.php/documents/ukk/3766-final-medical-device-registration-submission-guide-for-conformity-assessment-by-way-of-verification-process-and-submission-of-application-in-medc-st-second-edition
2026-08-25
3
6
months
3
6
months
No
No
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
class-c
Class C
high
Registration
30
30
working-days
official-verified
MDA/GD/0070 — registration submission guide, cl. 6.4 turnaround
https://www.mda.gov.my/index.php/documents/ukk/3766-final-medical-device-registration-submission-guide-for-conformity-assessment-by-way-of-verification-process-and-submission-of-application-in-medc-st-second-edition
2026-08-25
3
6
months
3
6
months
No
No
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Regulatory reference
Devices holding at least one qualifying approval from MDA-recognised authorities may use CAB conformity assessment by way of verification instead of full assessment: EU Notified Bodies (specified MDR/IVDR and legacy directive certificates), Japan MHLW (Ninsho/Shonin), Australia TGA (ARTG), Health Canada (licence), US FDA (510(k)/PMA), UK MHRA (UKCA for GB; EC/UKNI certificates for Northern Ireland), Singapore HSA (SMDR registration), Thailand FDA (Class 2-3 notified / Class 4 licensed device certificates).
Replaces the list formerly in MDA Circular Letter No. 1/2025 Annex 1; Second Edition (13 October 2025) added HSA and Thai FDA.
Regulatory reference
ARTG Registration Certificate from Australia TGA qualifies a Class B/C/D device for CAB conformity assessment by way of verification.
Prior approval / evidence record
class-d
Class D
highest
Full Registration
30
30
working-days
official-verified
MDA/GD/0070 — registration submission guide, cl. 6.4 turnaround
https://www.mda.gov.my/index.php/documents/ukk/3766-final-medical-device-registration-submission-guide-for-conformity-assessment-by-way-of-verification-process-and-submission-of-application-in-medc-st-second-edition
2026-08-25
3
6
months
3
6
months
Yes
No
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
Vía regulatoria abreviada — ARR equivalence (COFEPRIS-04-050)
The single reliance route since the DOF Acuerdo of 18 July 2025, which took effect 30 working days after publication and abrogated every individual equivalence agreement issued between 2012 and June 2025 — the separate FDA, Swissmedic, European Commission, Health Canada, TGA and WHO prequalification acuerdos no longer exist. COFEPRIS now recognises the decision of any Reference Regulatory Authority from a country sitting on the IMDRF Management Committee, and MDSAP full membership for GMP certificates. The dossier drops to an administrative-legal section plus technical information under RIS Art. 31.
Resolution within a maximum of 30 working days
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
class-ii
Class II
medium
Registration or Equivalency
35
35
days
official-verified
RIS Art. 179 — statutory resolution periods by class (COFEPRIS)
https://salud.gob.mx/unidades/cdi/nom/compi/ris.html
2026-08-25
15
31
months
8
16
months
No
No
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
class-iii
Class III
highest
Registration or Equivalency
60
60
days
official-verified
RIS Art. 179 — statutory resolution periods by class (COFEPRIS)
https://salud.gob.mx/unidades/cdi/nom/compi/ris.html
2026-08-25
15
31
months
8
16
months
Yes
No
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Regulatory reference
For medical devices, COFEPRIS recognizes as Autoridades Regulatorias de Referencia (ARR): countries that are members of the IMDRF Management Committee, and full members of the Medical Device Single Audit Program (MDSAP) for Good Manufacturing Practice certificates. Device registrations can be obtained through equivalence with prior ARR approvals via trámite COFEPRIS-04-050.
Effective from 2025-07-19
Effective date assumed day after DOF publication (18-07-2025) per standard transitorio wording of this type of Acuerdo; the mechanism is also described on the COFEPRIS reliance page.
Regulatory reference
The device's risk classification should be according to the jurisdiction of the country of origin; the application must state the regulatory jurisdiction the device follows: KSA (MDMA), USA, EU, Canada, Australia, Japan, or Others.
Presentation slide states 'Risk Classification ( It should be according to the country of origin jurisdiction)'.
Regulatory reference
Rule 67 names the reference countries and schemes whose market authorisations DRAP relies on: USA, Japan, Australia, Canada, Austria, Belgium, Denmark, France, Germany, Ireland, Italy, Netherlands, Norway, Spain, Sweden, Switzerland and United Kingdom, or devices pre-qualified by the World Health Organization, or CE marked by conformity assessment bodies (CABs) notified in the NANDO database under the relevant European directive for medical devices, subject to evidence and supporting documents.
Effective from 2018-01-16
Prior approval / evidence record
For IVDs, DINAVISA decides within 30 business days for products manufactured nationally or in a country of Annex I, within 45 business days for products manufactured outside Annex I but registered and commercialised in an Annex I country (which must additionally file the foreign registration certificate and free-sale certificate), and within 120 business days for other imports. Annex I names high-surveillance and adequate-surveillance authorities and the full MERCOSUR members; the United States and Japan are on it and Korea is not.
Sanitary registration and free-sale certificate in force in an Annex I country — high-surveillance authorities (Germany, Austria, Belgium, Canada, Denmark, Spain, United States, France, Israel, Italy, Japan, Netherlands, United Kingdom, Sweden, Switzerland) or adequate-surveillance authorities (Australia, Chile, Cuba, Finland, Hungary, Ireland, Luxembourg, Mexico, Norway, New Zealand); Annex I also lists full MERCOSUR members (Argentina, Brazil, Paraguay, Uruguay) and PAHO/WHO reference authorities
Abridged Or Recognition Route
facilitated
Premarket Review
Yes
Yes
Source language: Spanish. Translation of the quoted Annex I heading and entries: 'Countries with High and Adequate Sanitary Surveillance Authorities (Law 3283/07 Article 11)' / 'Countries with high sanitary surveillance regulatory authorities: Germany, Austria, Belgium, Canada, Denmark, Spain, United States, France, Israel, Italy, Japan, Netherlands, United Kingdom, Sweden and Switzerland.' / 'Full MERCOSUR members: Argentina, Brazil, Paraguay and Uruguay.' The excerpt is taken from the resolution's own Annex I; Art. 6 supplies the 30- and 45-business-day clocks.
Prior approval / evidence record
PAHO/WHO reference authority or IMDRF Management Committee member authority
Yes
Operative for class II, III and IV IVDs, which enter the Proceso Simplificado de Registro Sanitario under Resolución DINAVISA N° 44/2024 with a 15-business-day validation and approval by positive silence.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
Class II, III and IV in-vitro diagnostic products already authorised and commercialised in countries regulated by PAHO/WHO reference regulatory authorities, by authorities of IMDRF Management Committee member countries, or by authorities with bilateral agreements with DINAVISA enter the Proceso Simplificado de Registro Sanitario (PSR). DINAVISA has 15 business days to validate and decide, and approval follows by positive silence if no report is issued.
PAHO/WHO reference regulatory authorities; authorities of IMDRF Management Committee member countries (the IMDRF committee includes US FDA, EU, Japan PMDA/MHLW, Health Canada, TGA, ANVISA, China NMPA, Korea MFDS, Singapore HSA and UK MHRA); authorities with bilateral agreements with DINAVISA
Abridged Or Recognition Route
facilitated
Premarket Review
Yes
Yes
Effective from 2024-01-30
Source language: Spanish. Translation of the operative part of Art. 2: 'Applications for sanitary registration of In Vitro Diagnostic Products ... that are authorised and commercialised in countries regulated by: PAHO/WHO Reference Regulatory Authorities; Regulatory Authorities of member countries of the Committee of the International Medical Device Regulators Forum - IMDRF; Regulatory Authorities with which bilateral agreements with DINAVISA exist, shall be subject to the Simplified Sanitary Registration Process (PSR).' and 'DINAVISA shall have a term of 15 (fifteen) business days to validate the required documentation and decide thereon. Once the term has elapsed with no report from DINAVISA, the application shall be approved.' Article numbering confirmed by reading the page image of the official PDF.
Prior approval / evidence record
Proceso simplificado de Registro Sanitario (PSR) para productos para diagnóstico de uso in vitro
Class II, III and IV IVDs (Res. 44/2024 Art. 7) already authorised and commercialised by a recognised reference authority are validated in 15 business days with approval by positive silence, instead of the 30, 45 or 120 business days of the ordinary IVD route.
From 30-120 business days down to 15 business days
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Regulatory reference
For free-sale certificate and related evidence purposes, the high-vigilance countries are France, Netherlands, UK, USA, Canada, Japan, Switzerland, Germany, Spain, Australia, Denmark, Italy, Norway, Belgium and Sweden.
D.S. 018-2019-SA subsequently added Austria to this list (as shown on DIGEMID's normas-legales repository).
Prior approval / evidence record
País de Alta Vigilancia Sanitaria (art. 9 D.S. 016-2011-SA): United States, Canada, Japan, Australia, Switzerland, South Korea, United Kingdom, Germany, France, Netherlands, Spain, Italy, Belgium, Portugal, Ireland, Austria, Hungary, Denmark, Norway, Sweden
Yes
The Peruvian route to relying on a foreign approval is documentary, not procedural. A certificate of free sale or a GMP certificate issued by a high-surveillance authority is accepted directly, and if the issuing authority appears on the Resolución Directoral 169-2014-DIGEMID list the document does not need an apostille. Everything else still goes through DIGEMID certification.
None published — the TUPA period is set by class, not by origin
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
class-c
Class C
high
IBR/Expedited/Full Route
0
220
working-days
official-verified
HSA fees and turnaround time for medical devices
https://www.hsa.gov.sg/medical-devices/fees/
2026-03-26
2026-08-13
6
12
months
0.03
0.03
months
No
No
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
class-b
Class B
medium
IBR/Expedited/Full Route
0
160
working-days
official-verified
HSA fees and turnaround time for medical devices
https://www.hsa.gov.sg/medical-devices/fees/
2026-03-26
2026-08-13
3
9
months
0.03
0.03
months
No
No
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
Two reference approvals (any two of US FDA, EU Notified Body, Health Canada, Australia TGA, Japan MHLW)
Yes
At Class B this is the IBR trigger and registration is granted on submission. At Class C and D it is the ECR-2 or EDR trigger.
Class B immediate against 160 working days; Class C 120 against 220; Class D 180 against 310
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
Health Canada, Australia TGA, Japan MHLW
Yes
A Canadian or Australian device registration licence, or a Japanese Ninsho certification or Shonin approval, counts as a reference approval on the same terms as the US and EU.
Same as the abridged route figures above; two of them together trigger IBR, ECR-2 or EDR
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Regulatory reference
TGA (Australia) is one of HSA's overseas reference regulatory agencies; its prior approval qualifies a device for Abridged, and with marketing history or a second approval for Expedited/Immediate registration routes.
Confirms baseline reliance edge; route eligibility from the registration overview page.
Prior approval / evidence record
class-d
Class D
highest
IBR/Expedited/Full Route
180
310
working-days
official-verified
HSA fees and turnaround time for medical devices
https://www.hsa.gov.sg/medical-devices/fees/
2026-03-26
2026-08-13
9
18
months
6
12
months
Yes
No
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Regulatory reference
SAHPRA recognises six reference jurisdictions for reliance purposes: Australia, Brazil, Health Canada, Europe, Japan and USFDA, plus WHO prequalification of IVDs. For Class C and D devices listed in Certificate of Free Sale applications, evidence of pre-market approval/registration or emergency use authorisation from at least one of the six jurisdictions (or WHO PQ) is required.
The SAHPRA Medical Devices page confirms reliance pathways will use registrations in these recognised jurisdictions or WHO PQ.
Regulatory reference
For general medical devices, registrations from USA, UK, Australia, Canada, Japan, Norway, Switzerland and all EU member countries are considered under the reliance pathway; for IVD medical devices the same list applies plus Singapore.
Prior approval / evidence record
geo:tha
Australia TGA/ARTG market authorization evidence
Abridged Review
facilitated
Product Marketing
Yes
Yes
12
Page states the history condition verbatim: อย่างน้อย 1 ปีขึ้นไป.
Prior approval / evidence record
class-3
Class 3
high
Registration
250
250
days
official-verified
Thailand Ministerial Regulation B.E. 2563 — statutory review clocks (ข้อ ๕-๖)
https://medical.fda.moph.go.th/media.php?id=478924090456023040&name=กฏกระทรวงการแจ้งรายการละเอียดและการการออกใบรับแจ้งรายการละเอียดผลิตหรือนำเข้าเครื่องมือแพทย์ พ.ศ. 2563.pdf
2026-08-25
4
5
months
No
Yes
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
class-2
Class 2
medium
Registration
250
250
days
official-verified
Thailand Ministerial Regulation B.E. 2563 — statutory review clocks (ข้อ ๕-๖)
https://medical.fda.moph.go.th/media.php?id=478924090456023040&name=กฏกระทรวงการแจ้งรายการละเอียดและการการออกใบรับแจ้งรายการละเอียดผลิตหรือนำเข้าเครื่องมือแพทย์ พ.ศ. 2563.pdf
2026-08-25
4
5
months
No
Yes
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
class-4
Class 4
highest
Full Registration
300
300
days
official-verified
Thailand Ministerial Regulation B.E. 2563 — statutory review clocks (ข้อ ๕-๖)
https://medical.fda.moph.go.th/media.php?id=478924090456023040&name=กฏกระทรวงการแจ้งรายการละเอียดและการการออกใบรับแจ้งรายการละเอียดผลิตหรือนำเข้าเครื่องมือแพทย์ พ.ศ. 2563.pdf
2026-08-25
4
5
months
Yes
Yes
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
Health Canada or Australia TGA
Yes
A Canadian or Australian registration can serve as the free sale or registration certificate from the country of origin, but EDE names EC, 510(k) and PMA as the conformity certificate types.
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
WHO Prequalification, or quality-system certification from a certification body accredited by a regulatory authority in an IMDRF founding-member country, or any other international organisation recognised by NDA
Yes
Track 2: accepted as a documentary substitution for an IMDRF-country licence under DAR/GDL/028 §4.12.2 — the foreign element that unlocks the route is the quality-system certification and its accreditation rather than a product approval, and no shortened period is published for it.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
A product that is not licensed in an IMDRF founding-member country can still enter Track 2 by producing documented evidence of conformity to an accepted quality system standard from a certification body accredited by a regulatory authority in one of the IMDRF founding member countries, or WHO Prequalification, or any other international organisation recognised by NDA. This is a documentary substitution: the foreign element that unlocks the route is the quality-system certification and its accreditation, not a product approval. NDA's Medical Devices page states the same route for products 'prequalified by WHO or registered in SRA countries'.
WHO Prequalification, or ISO 13485/ISO 13488 (or the country-equivalent QS) certification issued by a certification body accredited by a regulatory authority in an IMDRF founding-member country; more broadly, registration in a country NDA treats as a stringent regulatory authority
Qms Audit Reliance
facilitated
Premarket Review
Yes
Yes
Effective from 2020-08-14
edgeType 'qms_audit_reliance' is reused from the existing vocabulary (4 prior uses): the mechanism is reliance on a third party's quality-system certification rather than on a product approval. NDA's page wording for this route ('Track 2 for Products prequalified by WHO or registered in SRA countries') is carried by the supporting source. The guideline does not define 'SRA'; the page's SRA language and the guideline's 'accredited by a regulatory authority in one of the IMDRF founding member countries' are not identical, and the fact is bounded to what the guideline says.
Prior approval / evidence record
A device already licensed in one of the IMDRF founding-member countries goes into Track 1, which NDA describes as an expedited review with shortened registration timelines whose evaluation process is abridged by the foreign approval. The applicant does not re-submit the full technical dossier: Track 1 requires a covering attestation, abbreviated product and manufacturer details, a notarized copy of the IMDRF-country licence, a Certificate of Analysis confirming compliance to an accepted quality system standard, evidence of repeat sales in the country of manufacture, product samples where practicable, and a completed submission checklist. The approval recognised is the one listed for the country in DAR/GDL/028 Table 2.
Australia: TGA GMPALS licence or CE mark; Canada: appliance licence; European Union: CE mark; Japan: MHLW appliance licence; United States: FDA 510(k) letter
Abridged Or Recognition Route
facilitated
Premarket Review
Yes
Yes
Effective from 2020-08-14
Excerpt joins the s. 4.12.1 heading with items (d) and (e) of the same list and with Table 2 verbatim, separated by [...]. NDA's Medical Devices page restates the same mechanism in its own words for the customer question: 'Foreign manufacturers entering the Ugandan market can leverage their existing approvals in recognized reference markets (Australia, Canada, European Union countries, Japan, and the United States) with expedited reviews and shortened registration timelines.' That page sentence is the supporting source's contribution and is why this is not marked source-backed-partial.
Prior approval / evidence record
Licence or approval from an IMDRF founding-member country — Australia, Canada, the European Union, Japan, the United States
Yes
Track 1: an abridged evaluation in which the foreign approval carries the technical assessment, with a much smaller submission (attestation, abbreviated product and manufacturer details, notarized copy of the licence, Certificate of Analysis to an accepted quality-system standard, evidence of repeat sales and product samples where practicable). It is an expedited review with shortened registration timelines, but NDA publishes no number for the shortening and the final decision remains NDA's.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
International Reliance (draft legislation, not in force)
Stand-alone route giving a Certificate of International Reliance to devices already authorised by the FDA, Health Canada or the TGA, without UKCA marking; the EU is deliberately excluded pending the separate CE-recognition decision
Not quantified — the draft fixes no review period
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
Regulatory reference
FDA (with TGA Australia, ANVISA Brazil, Health Canada, and MHLW/PMDA Japan) participates in the Medical Device Single Audit Program and may accept MDSAP audit reports as a substitute for routine Agency inspections; firms with Electronic Product Radiation Control (EPRC) activities remain subject to direct FDA inspection for those activities.
MDSAP official documents moved to the TGA-managed MDSAP website (FDA update of 2025-12-18).
Prior approval / evidence record
class-c
Class C
high
Circulation number registration (Ministry of Health)
45
45
days
official-verified
Nghị định 98/2021/NĐ-CP on the management of medical devices (as amended by Decrees 07/2023, 96/2023, 04/2025) — Art. 28 declaration for Class A/B and Art. 32 appraisal periods for Class C/D
https://vanban.chinhphu.vn/?pageid=27160&docid=204442
2022-01-01
2026-08-29
4
5
months
10
10
working-days
No
No
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
Prior approval / evidence record
class-d
Class D
highest
Circulation number registration (Ministry of Health)
45
45
days
official-verified
Nghị định 98/2021/NĐ-CP on the management of medical devices (as amended by Decrees 07/2023, 96/2023, 04/2025) — Art. 28 declaration for Class A/B and Art. 32 appraisal periods for Class C/D
https://vanban.chinhphu.vn/?pageid=27160&docid=204442
2022-01-01
2026-08-29
4
5
months
10
10
working-days
Yes
No
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
Prior approval / evidence record
Origin Country Evidence
Evidence Only
Disclosure of marketing approval in a SADC state, WHO Prequalification, US FDA approval, CE marking, or approval in any IMDRF member state
ZAMRA's device application form requires the applicant to disclose its foreign approvals: it must list the SADC states where the medical device has obtained marketing approval, attaching documentation, and state whether the device is WHO prequalified, US FDA approved, CE marked or approved in any IMDRF member state, attaching valid documentation. A separate dossier item requires documentary proof of registration of the product in other countries, specifically those in the SADC region. None of these approvals, however, gives a shortened or substitute route in the guidelines: the non-IVD guideline states only that an application 'shall be evaluated on a first come first serve basis unless expedited evaluation has been authorised by the Authority', and neither the non-IVD nor the IVD guideline provides that a WHO, FDA, CE or IMDRF approval triggers that authorisation or replaces any part of ZAMRA's assessment. An FDA or CE holder therefore still files the full ZAMRA dossier and obtains a Zambian marketing authorisation on ZAMRA's own evaluation. This is disclosure and evidence, not reliance.
Product Marketing
Yes
Yes
Effective from 2024-06-21
Verbatim from Annex I: 'List the SADC states where the medical device has obtained marketing approval (Attach documentation)' and 'Is the device WHO prequalified, US FDA approved, CE Marked or approved in any IMDRF member state? If so attach valid documentation'. Non-IVD guideline section 1(i): 'An application shall be evaluated on a first come first serve basis unless expedited evaluation has been authorised by the Authority.' Definition: '“expedited evaluation” means the express evaluation of a product application within a 90 – day period'.
Prior approval / evidence record
WHO Prequalification; US FDA approval; EU CE marking; approval in any IMDRF member state
No
Disclosure only. The Annex I application form requires the applicant to state whether the device is WHO prequalified, US FDA approved, CE marked or approved in any IMDRF member state and to attach valid documentation, but neither the non-IVD nor the IVD guideline attaches any procedural consequence — no shortened clock, no abridged dossier and no substitute for ZAMRA's own evaluation.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
MDSAP
Yes
Eliminates separate QMS audits
2-3 months
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
geo:aus
Medical Device Single Audit Program
Qms Audit Reliance
Evidence Only
Qms Audit
Yes
Yes
Prior approval / evidence record
geo:aus
Great Britain UKCA
Evidence Reuse
facilitated
Product Marketing
Yes
Yes
Prior approval / evidence record
class-iii
Class III — ARTG inclusion
highest
Inclusion in the ARTG on overseas or TGA conformity assessment evidence
20
20
working-days
6
9
months
3
5
months
No
No
Yes
official-verified
TGA — processing your application for inclusion of a medical device: the decision is notified within 20 working days after the day the application fee was paid
https://www.tga.gov.au/products/medical-devices/application-and-market-authorisation/supply-medical-device/medical-device-inclusion-process/processing-your-application-inclusion-medical-device
2026-08-30
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Regulatory reference
TGA accepts market-authorisation evidence only from its designated comparable overseas regulators and assessment bodies: EU notified bodies (MDD/AIMDD/IVDD, MDR, IVDR), US FDA (PMA and 510(k)), Health Canada, Japan MHLW/PMDA, Singapore HSA, and UK approved bodies designated by MHRA, with MDSAP certificates as manufacturer evidence. China's NMPA is not a comparable overseas regulator, so an NMPA registration certificate cannot be used as manufacturer evidence or product-assessment evidence for ARTG inclusion or to abridge a TGA conformity assessment.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
australia
All classes; ARTG inclusion applications and abridgement of TGA conformity assessment
No Reliance Route
none
Product Marketing
Yes
Yes
Effective from 2018-10-01
Source passage: Premarket approval and 510K decisions of the United States Food and Drug Administration (FDA) • Approvals and medical device licences issued by Health Canada • Pre-market approvals or certification from Japan (issued by the Ministry of Health, Labour and Welfare (MHLW), Pharmaceutical and Medical Devices Agency (PMDA) • Registrations or approvals of the Singapore Health Sciences Authority (HSA)
Prior approval / evidence record
geo:aus
EU CE under MDR/IVDR
Evidence Reuse
facilitated
Product Marking
Yes
Yes
Prior approval / evidence record
class-iib
Class IIb — ARTG inclusion
high
Inclusion in the ARTG on overseas or TGA conformity assessment evidence
20
20
working-days
1.5
2
months
1
1.5
months
No
No
Yes
official-verified
TGA — processing your application for inclusion of a medical device: the decision is notified within 20 working days after the day the application fee was paid
https://www.tga.gov.au/products/medical-devices/application-and-market-authorisation/supply-medical-device/medical-device-inclusion-process/processing-your-application-inclusion-medical-device
2026-08-30
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
geo:aus
Health Canada medical-device licence
Evidence Reuse
facilitated
Product Marketing
Yes
Yes
Prior approval / evidence record
FDA 510(k)
Yes
Accepted for Class IIa/IIb
20-30%
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
geo:aus
Japan MHLW/PMDA Ninsho or Shonin
Evidence Reuse
facilitated
Product Marketing
Yes
Yes
Prior approval / evidence record
class-iia
Class IIa — ARTG inclusion
medium
Inclusion in the ARTG on overseas or TGA conformity assessment evidence
20
20
working-days
1
1.5
months
0.75
1
months
No
No
Yes
official-verified
TGA — processing your application for inclusion of a medical device: the decision is notified within 20 working days after the day the application fee was paid
https://www.tga.gov.au/products/medical-devices/application-and-market-authorisation/supply-medical-device/medical-device-inclusion-process/processing-your-application-inclusion-medical-device
2026-08-30
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
Priority Review Pathway
Front-of-queue placement for novel devices addressing unmet needs
30-50% faster
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
EU CE Mark
Yes
Abridged assessment route - major timeline reduction
30-50%
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
geo:aus
US FDA 510(k), De Novo, or PMA
Evidence Reuse
facilitated
Product Marketing
Yes
Yes
Prior approval / evidence record
geo:aus
Singapore HSA product registration
Evidence Reuse
facilitated
Product Marketing
Yes
Yes
What review, validation, and applicant stop-clock rules apply?
Statutory assessment timeframes exclude any time the TGA is waiting for the applicant to respond to a notice, letter or request for information, or to pay assessment fees; audit work cannot begin until fees are paid.
Is an emergency, compassionate, custom, humanitarian, or other exceptional path available?
Unapproved medical devices may be supplied for individual patients under the Special Access Scheme: Category A (notification by a medical practitioner for seriously ill patients), Category B (prior TGA approval; processed in about 2-5 days; generally inappropriate for reusable multi-patient devices), and Category C (established-history device lists, notification); the Authorised Prescriber scheme and clinical trial schemes are alternatives.
How are deficiencies answered, clocks handled, and decisions escalated or appealed?
External merits review is now conducted by the Administrative Review Tribunal (ART), which replaced the Administrative Appeals Tribunal (AAT); all cases before the AAT immediately prior to 14 October 2024 were automatically transferred to the ART.
Effective from 2024-10-14
A person dissatisfied with a Ministerial reconsideration decision may apply to the Administrative Review Tribunal (ART) for merits review; the application must be made in writing within 28 days after the day notice of the reconsideration decision is given, subject to the Administrative Review Tribunal Act 2024.
A person whose interests are affected by a reviewable initial decision may request the Minister for Health to reconsider it under s 60 of the Act (or reg 48 TG Regs 1990 / reg 10.7 MD Regs 2002); requests incur no fee and must generally be made within 90 calendar days of notice; if no decision issues within 60 days the initial decision is taken to be confirmed. Preliminary-assessment refusals and s 41FH audit-selection or s 41JA information-request decisions are not reviewable.
Which UDI, device listing, database, and traceability duties apply?
Sponsors of devices that do not comply with applicable UDI requirements must seek TGA consent to import and supply under sections 41MA and 41MAA of the Therapeutic Goods Act 1989. The streamlined UDI Consent to Supply application fee published by TGA is AUD 80 for the first ARTG entry and AUD 10 for each additional entry in the same application.
Effective from 2026-07-01
TGA page updated 5 August 2026; current page independently checked 18 September 2026. Fee is a dated published amount, not a guarantee against future tariff changes.
TGA states that Unique Device Identification (UDI) requirements became mandatory for high-risk medical devices from 1 July 2026 under the Therapeutic Goods (Medical Devices) Regulations 2002.
Effective from 2026-07-01
The cited Consent to Supply page establishes the high-risk commencement date; it does not specify the complete class-by-class schedule or database submission rules.
What is reportable, by whom, where, in what format, and by what deadline?
It is an automatic condition of ARTG inclusion (cl 5.7, Part 5 Div 5.2 of the MD Regulations) that sponsors report adverse events and near adverse events to the TGA via IRIS; all adverse events for devices supplied in Australia are required to be reported.
48 hours for a serious threat to public health; 10 days for death or a serious deterioration; 30 days where an event might have led to death or serious deterioration
final report within 120 calendar days of the initial report
follow-up information at least every 30 calendar days
MDIR application in TGA Business Services; only Australian events are reportable, overseas remedial actions go to the TGA recalls team
australia:ivd
australia
Australia IVD risk classification
1
IVD Class 1
low
2
IVD Class 2
medium
3
IVD Class 3
high
4
IVD Class 4
highest
TGA
official-source-verified
TGA overview of medical devices and IVD regulation
https://www.tga.gov.au/products/medical-devices/overview/overview-medical-devices-and-ivd-regulation
2026-08-13
australia:medical-device
australia
General-device classes I, Is, Im, IIa, IIb, III and AIMD.
i
Class I
low
is
Class Is
low
im
Class Im
low
iia
Class IIa
medium
iib
Class IIb
high
iii
Class III
highest
aimd
AIMD
highest
TGA
official-source-verified
TGA overview of medical devices and IVD regulation — classification of medical devices
https://www.tga.gov.au/products/medical-devices/overview/overview-medical-devices-and-ivd-regulation
2026-08-25
Australia
australia
AU
🇦🇺
Therapeutic Goods Administration
TGA
asia-pacific
1
5-class (I, IIa, IIb, III, AIMD)
class-i
Class I — ARTG inclusion
low
Inclusion in the Australian Register of Therapeutic Goods
20
20
working-days
0.5
1
months
No
No
No
official-verified
TGA — processing your application for inclusion of a medical device: the decision is notified within 20 working days after the day the application fee was paid
https://www.tga.gov.au/products/medical-devices/application-and-market-authorisation/supply-medical-device/medical-device-inclusion-process/processing-your-application-inclusion-medical-device
2026-08-30
class-iia
Class IIa — ARTG inclusion
medium
Inclusion in the ARTG on overseas or TGA conformity assessment evidence
20
20
working-days
1
1.5
months
0.75
1
months
No
No
Yes
official-verified
TGA — processing your application for inclusion of a medical device: the decision is notified within 20 working days after the day the application fee was paid
https://www.tga.gov.au/products/medical-devices/application-and-market-authorisation/supply-medical-device/medical-device-inclusion-process/processing-your-application-inclusion-medical-device
2026-08-30
class-iib
Class IIb — ARTG inclusion
high
Inclusion in the ARTG on overseas or TGA conformity assessment evidence
20
20
working-days
1.5
2
months
1
1.5
months
No
No
Yes
official-verified
TGA — processing your application for inclusion of a medical device: the decision is notified within 20 working days after the day the application fee was paid
https://www.tga.gov.au/products/medical-devices/application-and-market-authorisation/supply-medical-device/medical-device-inclusion-process/processing-your-application-inclusion-medical-device
2026-08-30
class-iii
Class III — ARTG inclusion
highest
Inclusion in the ARTG on overseas or TGA conformity assessment evidence
20
20
working-days
6
9
months
3
5
months
No
No
Yes
official-verified
TGA — processing your application for inclusion of a medical device: the decision is notified within 20 working days after the day the application fee was paid
https://www.tga.gov.au/products/medical-devices/application-and-market-authorisation/supply-medical-device/medical-device-inclusion-process/processing-your-application-inclusion-medical-device
2026-08-30
conformity-assessment-new
TGA Conformity Assessment certificate — new or substantial change
TGA-issued conformity assessment certification
160
200
working-days
10
15
months
Yes
official-verified
TGA — applying for a Conformity Assessment certificate for medical devices: Regulation 4.3 requires processing within 255 working days, with non-legislated targets of 160/200 business days for new or substantial applications, 190/225 where ACMD advice or an on-site audit is needed, and 80/150 for recertification
https://www.tga.gov.au/resources/guidance/applying-conformity-assessment-certificate-medical-devices
2026-08-30
conformity-assessment-committee-or-onsite-audit
TGA Conformity Assessment certificate — ACMD advice or on-site facility audit
TGA-issued conformity assessment certification with committee referral or on-site audit
190
225
working-days
12
16
months
Yes
official-verified
TGA — applying for a Conformity Assessment certificate for medical devices: Regulation 4.3 requires processing within 255 working days, with non-legislated targets of 160/200 business days for new or substantial applications, 190/225 where ACMD advice or an on-site audit is needed, and 80/150 for recertification
https://www.tga.gov.au/resources/guidance/applying-conformity-assessment-certificate-medical-devices
2026-08-30
conformity-assessment-recertification
TGA Conformity Assessment certificate — recertification
Recertification of an expiring TGA conformity assessment certificate
80
150
working-days
6
10
months
Yes
official-verified
TGA — applying for a Conformity Assessment certificate for medical devices: Regulation 4.3 requires processing within 255 working days, with non-legislated targets of 160/200 business days for new or substantial applications, 190/225 where ACMD advice or an on-site audit is needed, and 80/150 for recertification
https://www.tga.gov.au/resources/guidance/applying-conformity-assessment-certificate-medical-devices
2026-08-30
Priority Review Pathway
Front-of-queue placement for novel devices addressing unmet needs
30-50% faster
EU CE Mark
Yes
Abridged assessment route - major timeline reduction
30-50%
FDA 510(k)
Yes
Accepted for Class IIa/IIb
20-30%
MDSAP
Yes
Eliminates separate QMS audits
2-3 months
Yes
Australian Sponsor
Yes
Eliminates separate TGA QMS audits, 5-year certificate validity
5 years
2026-08-30
official-verified
2026-08-30
TGA — processing your application for inclusion of a medical device: the decision is notified within 20 working days after the day the application fee was paid
https://www.tga.gov.au/products/medical-devices/application-and-market-authorisation/supply-medical-device/medical-device-inclusion-process/processing-your-application-inclusion-medical-device
2026-08-30
TGA — applying for a Conformity Assessment certificate for medical devices: Regulation 4.3 requires processing within 255 working days, with non-legislated targets of 160/200 business days for new or substantial applications, 190/225 where ACMD advice or an on-site audit is needed, and 80/150 for recertification
https://www.tga.gov.au/resources/guidance/applying-conformity-assessment-certificate-medical-devices
2026-08-30
TGA — understanding the medical device application audit process: statutory 20-working-day preliminary assessment, non-IVD Level 2 first-round specialist assessment expected in 100 working days, sponsor responses due in 20-40 business days
https://www.tga.gov.au/resources/guidance/understanding-medical-device-application-audit-process
2026-08-30
TGA — understanding processing timeframes for medical device applications: published half-yearly snapshot of actual processing times by application and audit type
https://www.tga.gov.au/resources/guidance/understanding-processing-timeframes-medical-device-applications
2026-08-30
TGA — varying your medical device or IVD ARTG entry: software transition variations carry a 3-5 business day target, and section 41JA or section 31 notices allow not less than 10 working days to respond
https://www.tga.gov.au/resources/resources/user-guide/varying-your-medical-device-or-ivd-artg-entry
2026-08-30
default
planning-template
Maintained planning steps and estimates, not verified regulator deadlines.
1
Pre-Submission Preparation
Gather technical documentation, quality management system (QMS) records, and clinical data required by TGA. Appoint a Australian Sponsor.
1-3 months
📋
2
Application Submission
Submit complete registration dossier to TGA including device description, risk analysis, and testing reports.
1-2 weeks
📤
3
Administrative Review
TGA reviews application for completeness. May request additional documents or clarifications.
2-4 weeks
🔍
4
Technical Evaluation
In-depth technical assessment of device safety and performance. TGA may issue questions.
20 working days
⚙️
5
Registration Approval
Upon successful review, TGA issues Australia market authorization certificate.
1-2 weeks
✅
Australia
australia
AU
TGA
121
879
AUD
Yes
1244
1662
AUD
Yes
annual-charge-class-i-other
Annual Charge - Class I (other)
AUD
121
AUD 121
Annual per ARTG entry
official-verified
https://www.tga.gov.au/sites/default/files/2026-06/fees-charges-summary-1-july-2026.pdf
TGA fees and charges summary from 1 July 2026
2026-07-01
2026-08-25
exact-current
annual-charge-class-i-measuring-sterile
Annual Charge - Class I (measuring/sterile)
AUD
879
AUD 879
Annual per ARTG entry
official-verified
https://www.tga.gov.au/sites/default/files/2026-06/fees-charges-summary-1-july-2026.pdf
TGA fees and charges summary from 1 July 2026
2026-07-01
2026-08-25
exact-current
annual-charge-class-iia-iib
Annual Charge - Class IIa/IIb
AUD
1305
AUD 1,305
Annual per ARTG entry
official-verified
https://www.tga.gov.au/sites/default/files/2026-06/fees-charges-summary-1-july-2026.pdf
TGA fees and charges summary from 1 July 2026
2026-07-01
2026-08-25
exact-current
annual-charge-class-iii-aimd
Annual Charge - Class III/AIMD
AUD
1662
AUD 1,662
Annual per ARTG entry
official-verified
https://www.tga.gov.au/sites/default/files/2026-06/fees-charges-summary-1-july-2026.pdf
TGA fees and charges summary from 1 July 2026
2026-07-01
2026-08-25
exact-current
application-fee-class-i
Application Fee - Class I
AUD
651
AUD 651
Per ARTG inclusion application
official-verified
https://www.tga.gov.au/sites/default/files/2026-06/fees-charges-summary-1-july-2026.pdf
TGA fees and charges summary from 1 July 2026
2026-07-01
2026-08-25
exact-current
application-fee-class-iia-iib
Application Fee - Class IIa/IIb
AUD
1244
AUD 1,244
Per ARTG inclusion application
official-verified
https://www.tga.gov.au/sites/default/files/2026-06/fees-charges-summary-1-july-2026.pdf
TGA fees and charges summary from 1 July 2026
2026-07-01
2026-08-25
exact-current
application-fee-class-iii
Application Fee - Class III
AUD
1603
AUD 1,603
Per ARTG inclusion application
official-verified
https://www.tga.gov.au/sites/default/files/2026-06/fees-charges-summary-1-july-2026.pdf
TGA fees and charges summary from 1 July 2026
2026-07-01
2026-08-25
exact-current
ivd-annual-charge
IVD Annual Charge
AUD
948
AUD 948
Annual per ARTG entry
official-verified
https://www.tga.gov.au/sites/default/files/2026-06/fees-charges-summary-1-july-2026.pdf
TGA fees and charges summary from 1 July 2026
2026-07-01
2026-08-25
exact-current
ivd-application-fee
IVD Application Fee
AUD
1244
AUD 1,244
Per ARTG inclusion application
official-verified
https://www.tga.gov.au/sites/default/files/2026-06/fees-charges-summary-1-july-2026.pdf
TGA fees and charges summary from 1 July 2026
2026-07-01
2026-08-25
exact-current
udi-consent-to-supply-first-entry
UDI Consent to Supply application - first ARTG entry
AUD
80
AUD 80
Per application
exact-current
official-verified
https://www.tga.gov.au/products/medical-devices/labelling-and-advertising/unique-device-identification-udi-hub/udi-information-sponsors-and-manufacturers/unique-device-identification-consent-supply-process
TGA Unique Device Identification Consent to Supply process and application fee
2026-08-25
udi-consent-to-supply-additional-entry
UDI Consent to Supply - each additional ARTG entry in the same application
AUD
10
AUD 10
Per additional entry
exact-current
official-verified
https://www.tga.gov.au/products/medical-devices/labelling-and-advertising/unique-device-identification-udi-hub/udi-information-sponsors-and-manufacturers/unique-device-identification-consent-supply-process
TGA Unique Device Identification Consent to Supply process and application fee
2026-08-25
2026-08-25
official-verified
TGA fees and charges summary from 1 July 2026
https://www.tga.gov.au/sites/default/files/2026-06/fees-charges-summary-1-july-2026.pdf
2026-07-01
2026-08-25
TGA Unique Device Identification Consent to Supply process and application fee
https://www.tga.gov.au/products/medical-devices/labelling-and-advertising/unique-device-identification-udi-hub/udi-information-sponsors-and-manufacturers/unique-device-identification-consent-supply-process
2026-08-25
TGA user guide: varying your medical device or IVD ARTG entry
https://www.tga.gov.au/resources/resources/user-guide/varying-your-medical-device-or-ivd-artg-entry
2026-08-25
TGA annual charges for therapeutic goods
https://www.tga.gov.au/products/regulations-all-products/fees-and-payments/annual-charges/annual-charges-therapeutic-goods
2026-08-25
2026-08-25
exact-current
Yes
australia
Australia
high
tga-electrical-emc-evidence
TGA electrical/EMC evidence
Medical Electrical Safety
Included In Medical Registration
Finished Device
TGA conformity-assessment audits the manufacturer QMS against regulatory requirements and internationally recognised standards, specifically ISO 13485:2016 (on-site or desktop assessments); microbiology and sterility assessments may reference ISO 11135 (ethylene oxide), the ISO 11137 series (radiation processing) and AAMI TIR 56.
candidate
eess
EESS
General Electrical Components
Mandatory If Feature
Household Device Or Component
Professional/TGA-regulated medical equipment is generally outside scope; household equipment and adapters require a separate scope test.
reviewed
acma-rcm
ACMA RCM
Radio Spectrum
Mandatory If Feature
Radio Or Emc Equipment
candidate
arpansa-state-radiation-licensing
ARPANSA/state radiation licensing
Ionizing Radiation
Mandatory For Use Site
Facility Or Commonwealth Entity
candidate
ACMA
technical standards and RCM
https://www.acma.gov.au/technical-standards
EESS
medical equipment scope guidance
https://www.eess.gov.au/wp-content/uploads/2020/07/20-009-General-guidance-Requirements-for-medical-equipment-the-EESS.pdf
ARPANSA
radiation regulation and licensing
https://www.arpansa.gov.au/regulation-and-licensing/licensing
TGA
conformity assessment certificate guidance QMS audit and sterility standards
https://www.tga.gov.au/resources/guidance/applying-conformity-assessment-certificate-medical-devices
