Explore the IVD requirements currently available for Australia, organized by topic and linked to official sources.
Common questions about changing a registered IVD in Australia. Each question separates published rules from details still awaiting verification.
Does the event require internal documentation, notice, prior approval, transfer, or a new application?
One DCR may cover up to ten ARTG entries only where the requested change is the same for each entry. This is distinct from listing additional entries in a sponsor-transfer form and from the conditional 215-dollar evidence-update tariff. Separate approval prerequisites still apply; these provisions do not establish every transfer-plus-name/brand/REF event as one filing.
An ARTG variation must preserve the same kind of device: sponsor, manufacturer, GMDN, class and the applicable prescribed characteristics/UPI. For manufacturer name or address changes, TGA checks whether responsibility for design, production, packaging and labelling and the QMS remain the same. A same-entity office/name update with unchanged QMS can be accepted; changed control or QMS can require a new inclusion. A sponsor transfer is a different legal event.
Which evidence, local deltas, formats, and signatures are required?
If the importing country needs a certificate, the sponsor/authorised agent may seek CFS for current Australian-supply ARTG devices or Export Certificate for export-only entries. Correct ARTG details before applying; the exports team does not amend them. The form needs sponsor/client and ARTG/GMDN details, declaration and the applicable payment; one form/one optional schedule per certificate. More than five devices need a schedule, not automatic rejection. TGA aims for ten working days; this is a separate export service, not ordinary change approval or automatic certificate reissue.
The transfer form identifies both sponsors/client IDs, affected ARTG entries, event/date and declarations by authorised representatives; extra entries use an attached list. Submit after the transfer has occurred and identify pending variations. Manufacturer Evidence is not transferred with sponsorship: the new sponsor first obtains accepted evidence, then submits DCR to link it to the ARTG. That order is separate from the legal event transferring sponsorship.
For Class 1-3 IVDs, adding a device of the kind that meets the notification criteria uses the IVD Variation form and the manufacturer Australian DoC. Existing ARTG information/performance or intended-purpose updates use DCR; the specified combined additional-device/intended-purpose case includes the replacement-purpose document. Do not delete an active IVD unless supply has ceased. Class 4 IVDs have a single UPI and do not use that IVD variation form. Wait for approval before implementing a variation.
Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?
Under Regulations 10F/10FA, qualifying sponsor succession/assignment and sponsor-name events are notified in the approved manner within three months. An agreed business/interest transfer carries the inclusion to the new sponsor when the event occurs; it is not a discretionary transfer by a foreign manufacturer. A same sponsor with unchanged ABN/ACN uses the name form; changed ABN/ACN requires new organisation identification and the applicable transfer process.
What regulator fee applies to this class, route, event, and date?
Current Schedule 9 item 2A (d) sets AUD 1982 for Class 3/4 IVD variation and (e) AUD 1133 for other IVD variation, each excluding the (g) case and data evaluation. Item (g) statutorily covers a medical device meeting all three EU-transition/sole-evidence-update/same-evidence conditions at AUD 215 per ten entries or part. The summary table describes (g) as non-IVD; preserve that discrepancy rather than impose the summary exclusion over the statute.
Which label and IFU elements, languages, symbols, and translation controls apply?
The shared medical-device provisions expressly cover IVDs: Essential Principle 13 requires the applicable manufacturer name/trading name, address, device identity, lot/date and English information. Regulation 10.2 also requires readily identifiable sponsor name/address; added sponsor labels must not adulterate the device or obscure manufacturer information. These are information/location requirements, not a general old-label stock grace.
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.)."
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
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
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
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
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
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
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
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.
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
What review, validation, and applicant stop-clock rules apply?
There is no fee for the sponsor transfer/name notification itself. TGA says it normally updates the ARTG within ten working days of a fully completed, signed notification and any required information; the form describes this as an aim. This administrative processing target does not defer legal sponsorship responsibility until the record is updated or price additional ARTG variations.
The current-linked TGA variation guide expressly says there is no legislated timeframe for evaluating an ARTG variation. Its 3-5-business-day target applies only to the stated Class III programming-software variation after the new hardware is approved. The reasonable information-request response period of at least ten working days is an applicant deadline, not a general evaluation SLA.
Which UDI, device listing, database, and traceability duties apply?
For a UDI medical device, Essential Principle 13C.2 treats the listed brand-name, model/version and packaging changes as a different type of model, with corresponding database identifiers. Changes made in the same production change are treated together; the pre-change device remains its prior type. Database timing depends on the applicable general start day and supply event. A commercial REF must first be mapped to these fields; UDI consequences do not themselves determine ARTG new-kind or variation classification.
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
These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.
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
✅
These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.
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
These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.
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
