Does Customs Act 1901 — import declarations + duties apply to medical devices and therapeutic goods?

Customs Act 1901 — import declarations + duties. Section 71A of the Customs Act 1901 defines an import declaration (the N10) as the communication to the Department of Home Affairs of information about goods intended to be entered for home consumption. It is usually lodged electronically through the Integrated Cargo System, or on the approved paper forms B650 (sea or air cargo) and B374 (international mail), and covers the owner's details and identifier (ABN, ABN/CAC or CCID), transport details, and the customs value built up from invoice, freight, insurance and other costs, expressed in Australian dollars.

Trigger: Importing goods by sea, air or mail that are required to be entered, including goods held in a licensed warehouse being released for home consumption.

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 "Customs Act 1901 — import declarations + duties" 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

Before the goods can be released from customs control into home consumption; if goods are not entered within the prescribed period, a Collector may move them to a warehouse at the owner's cost and, after a further period, sell or dispose of them (s 72).

Evidence to keep

Lodged import declaration and import entry advice; commercial invoice, freight and insurance documents supporting the customs value; tariff classification and origin evidence for any concession or free trade agreement claim; permits for restricted goods; duty and GST payment records; any amber statement or voluntary error notice lodged to correct a declaration.

Maximum penalty

Making a false or misleading statement in a declaration that reduces duty is a strict liability offence with a fine of up to the greater of 60 penalty units ($21,840) and the duty shortfall (Customs Act 1901 s 243T); where no duty is lost the fine is up to 60 penalty units per false or misleading statement (s 243U). The Act also provides for infringement notices (s 243X), and the offences do not apply where a written error notice is given voluntarily before the person receives a notice under s 214AD.

Regulator

ABF

Jurisdiction

Commonwealth (national)

• Conduct post-market surveillance of therapeutic goods: Yes
• In-vitro diagnostic medical device classification + ARTG: Yes
• Comply with anti-dumping + countervailing duties: Only if
• Comply with self-assessed clearance + Integrated Cargo System (ICS): Only if
• Comply with the Therapeutic Goods Advertising Code: Yes
• Notify ACCC of a voluntary recall within 2 days: Yes
• All 8 answers for medical devices & therapeutic goods