Do medical devices and therapeutic goods need to comply with self-assessed clearance + Integrated Cargo System (ICS)?

Comply with self-assessed clearance + Integrated Cargo System (ICS). Under section 68 of the Customs Act 1901, the owner of goods imported into Australia must enter them for home consumption or for warehousing. For goods to be cleared into the Australian market, that entry is made by an import declaration under section 71A, communicated to the Department of Home Affairs electronically through the Integrated Cargo System (ICS) or by document.

Trigger: Importing goods into Australia, or goods intended for import being on board a ship or aircraft that has commenced its journey to Australia.

Rules Mate runs its applicability engine across 9 business structures and 6 size bands for each of the 35 industries it maps. For 30 of those industries the answer for "Comply with self-assessed clearance + Integrated Cargo System (ICS)" is no. Medical devices & therapeutic goods is one of the 5 where the answer is different: only if.

The deciding fact for medical devices and therapeutic goods: Industry: Medical devices & therapeutic goods; applies only if you import goods into Australia.

About the industry: Suppliers of therapeutic goods listed on the ARTG.

Compare a professional services (general) business with 6–19 employees structured as a Pty Ltd company: the obligation does not apply (Requires a trigger outside this questionnaire).

Each cell is the engine's outcome for a business in medical devices & therapeutic goods with that structure and size, assuming it sells to consumers and small businesses and holds customer contact details. "Check" means the obligation turns on a fact the industry does not settle.

When due

The goods may be entered before the ship or aircraft first arrives at the discharge port or airport, and must be entered after arrival if not entered earlier; under section 71C an authority to take the goods into home consumption is generally given only once the goods are cleared and duty, assessed GST and the import declaration processing charge are paid (deferral schemes aside).

Evidence to keep

Import declarations (N10) or self-assessed clearance declarations and ICS lodgement records; commercial invoices, bills of lading or air waybills; tariff classification and valuation working papers; origin evidence for any preferential rate; import permits; broker authorities; records of any voluntary error notices and amended declarations.

Maximum penalty

False or misleading statement to an officer resulting in loss of duty (Customs Act 1901 s 243T, strict liability): a fine of the greater of 60 penalty units ($21,840) or the amount of duty underpaid. A false or misleading statement not resulting in loss of duty (s 243U): up to 60 penalty units ($21,840) for each false statement. Underpaid duty remains recoverable

Regulator

ABF

Jurisdiction

Commonwealth (national)

• Comply with anti-dumping + countervailing duties: Only if
• Conduct post-market surveillance of therapeutic goods: Yes
• In-vitro diagnostic medical device classification + ARTG: Yes
• Comply with the Therapeutic Goods Advertising Code: Yes
• Customs Act 1901 — import declarations + duties: Only if
• Notify ACCC of a voluntary recall within 2 days: Yes
• All 8 answers for medical devices & therapeutic goods