Question: Topic : Australia , I should answer these question but for Australia country Does the product (a medical device class 1 in Europe, certified by

Topic : Australia , I should answer these question but for Australia country

Does the product (a medical device class 1 in Europe, certified by the company only) need to be certified by an external body to be sold in the proposed market? If so, how could such certification be obtained, and who is granting it? Are there any other legal requirements or cultural necessities with respect to the product packaging, labeling, branding, etc.?

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