On November 2, 2017, Chinese Food & Drug Administration (CFDA) released a new regulation which requires overseas applicants/manufacturers to include the standardized Chinese translation of company information within their applications. The Chinese name of the applicant should be translated in the format of simplified Chinese and in conformity with the national standard of language. The… Learn more
Australia has a universal healthcare system (Medicare). There is also has a private health insurance option that covers admissions into private hospitals. It is understandable that most Australians who are not health economists (unlike yours truly) would consider themselves sufficiently covered for a private hospital admission if they had taken up private health insurance. The… Learn more
In what was not a surprise based on the industry feedback, the Australian regulator of therapeutic goods (Therapeutic Goods Administration) will return to the drawing board with their proposed changes to the regulatory controls of 3D devices in hope to better define the scope of the changes. Late 2017, the TGA released a consultation paper… Learn more
In a surprising turn, the Therapeutic Goods Administration (TGA), Australian regulator of therapeutic goods, has announced the introduction of an application fee for Class I devices. Until now, class I devices entered into the register in Australia have had no application fee, but did have an annual license fee. This has likely permitted some products… Learn more
Manufacturers who have TGA registrations but haven’t yet started sales can claim relief from TGA annual charges – but only if they act very quickly. Through the TGA’s Annual Charge Exemption (ACE) Scheme, products which have generated zero turnover may be exempt from incurring the annual charges. This applies only to products registered within the… Learn more
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LIVE WEBINAR: Market Access in Australia – leveraging international approvals for TGA registrations
Did you know that more than 90% of medical device registrations in Australia are granted based on prior CE marking? And most of these registrations are done within a few weeks and sometimes in a few days. Read More
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