We understand our clients' businesses and the delivery of healthcare and community services can lead to extensive governance and regulatory requirements.
Henry Davis York has a strong understanding of the regulatory frameworks applicable to healthcare providers, including for example in New South Wales, the Private Health Facilities Act 2007 and Private Health Facilities Regulation 2010. Our expertise includes assisting with licensing and compliance issues, responding to regulatory inquiries and investigations, advising on the use and storage of personal information and reviews of products and processes.
- Advising a major retail chain on obligations under the Therapeutic Goods Act on medical devices supplied by the retail chain, including preparing a TGA Compliance Guide for the retail chain setting out all relevant obligations under the TGA, Therapeutic Goods Regulations and Therapeutic Goods (Medical Devices) Regulations, the classification system, the Essential Principles, manufacturers' obligations, sponsors' obligations, product information requirements, advertising requirements and recalls.
- Advising on the regulatory and compliance issues associated with the sale of a specialist mental healthcare practice to an ASX-listed private hospital care group.
- Advising on the regulatory and compliance issues associated with fertility clinic to an international and specialist assisted reproductive technology (ART) and tertiary level diagnostic ultrasound business.
- Preparing a Legal Compliance Register for a major pharmaceutical company in respect of its compliance with the Therapeutic Goods Act and Therapeutic Goods Regulations, including a short form Checklist of compliance obligations, and updating the Legal Compliance Register on an annual basis for changes in law.