Import & Export Requirements for Used Medical Equipment in Oceania

CountryLicensing/permitsRegulationsCustoms proceduresMiscellaneous
notes
Oceania
Australia- Importers may need a general import license for certain used medical equipment
- Permits might be necessary depending on the type and condition of the equipment
- All medical devices must comply with Australian standards for safety, quality, and efficacy
- Equipment must be accurately labeled and include the country of origin
- Used medical equipment must be accurately declared on customs documents
- Commercial invoice, Bill of Lading, and other relevant documents
- Used medical equipment is subject to additional scrutiny by the Therapeutic Goods Administration (TGA).
Fiji- Import permits may be required.- Used medical equipment must comply with the Medicinal Products Act 2011
- Must be sourced from reputable suppliers and meet quality standards
- Equipment must be cleared for biosecurity risks if applicable
- Commercial invoice, Bill of Lading, and other relevant documents.
Micronesia- There are no specific requirements for importing medical items into Micronesia.
New Zealand- No specific import permits required for used medical equipment.- Medical devices must be notified to the WAND database within 30 days of becoming a sponsor.
- A New Zealand Sponsor is required for importation.
- Medical devices must meet safety, quality, and efficacy standards under the Medicines Act 1981 and the Medicines (Database of Medical Devices) Regulations 2003.
- Commercial invoice, Bill of Lading, and other relevant documents.
Palau- There are no specific requirements for importing medical items into Palau.
Papua New Guinea- Import of used medical equipment requires a permit or license.- Used medical equipment must comply with packaging and labeling requirements under the Packaging Act.
- Must include the approved brand or packer’s details.
- Bill of Lading, Commercial Invoice, Packing List/Inventory List, Customs Valuation Declaration/Customs Entry
- Import declaration via Direct Trader Input (DTI) system by licensed agent.
- Goods may be subject to inspection by customs at any point.

Oceania

 

Australia

https://www.trade.gov/country-commercial-guides/australia-customs-regulations

https://www.abf.gov.au/importing-exporting-and-manufacturing/importing/how-to-import/import-declaration

https://iamers.org/2015/05/pre-owned-medical-importation-by-country/

https://www.tga.gov.au/resources/resource/reference-material/importing-and-supplying-medical-devices#:~:text=Does%20the%20TGA%20regulate%20medical,goods%20in%20section%203%20include:

 

Fiji

https://www.trade.gov/country-commercial-guides/fiji-customs-regulations

https://baronworldwide.com/wp-content/uploads/2019/02/fiji.pdf

https://www.health.gov.fj/fiji-mra/#:~:text=Provisionally%20Authorised%20Medicinal%20Products%20Register,in%20Australia%20or%20New%20Zealand.&text=Once%20logged%20in%2C%20you%20must,company%20details%2C%20and%20license%20documents.

 

Micronesia

https://www.state.gov/reports/2022-investment-climate-statements/micronesia/#:~:text=investment%20is%20negligible.-,2.,Base%20Erosion%20and%20Profit%20Shifting.

https://lca.logcluster.org/13-micronesia-customs-information#:~:text=*%20Medical%20Items%2D%20There%20are%20no%20specific,Satellite%20phones%20/%20VHF%20or%20HF%20radios.

 

New Zealand

https://www.regdesk.co/resource-library/new-zealand/#:~:text=purpose;%20and%20ii.-,does%20not%20achieve%20its%20principal%20intended%20action%20in%20or%20on,purposes%20of%20the%20Medicines%20Act.&text=It%20is%20a%20mandatory%20requirement,being%20supplied%20in%20New%20Zealand.

https://www.freyrsolutions.com/blog/decoding-new-zealands-medical-device-regulations#:~:text=Notification%20to%20WAND:%20All%20medical,Medical%20Devices)%20Regulations%2C%202003.

https://www.medsafe.govt.nz/regulatory/DevicesNew/faqs.asp#:~:text=If%20you%20are%20still%20not,in%20the%20’Components’%20section.

 

Papua New Guinea

https://www.trade.gov/country-commercial-guides/papua-new-guinea-customs-regulations

https://customs.gov.pg/pdf/pages/HS%202022%20Import%20&%20Export%20Tariff%20Act.pdf

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