The TGA, Australia has published a checklist for manufactures of medical devices to demonstrate compliance with the essential principles for their medical devices.
TGA states that it is the manufacturer’s responsibility to demonstrate compliance with the essential principles for their medical devices. According to the website, this is an update for programmed or programmable medical device or software that is a medical device. Unusually for the TGA, no further information is provided to add greater context to the checklist.
The comprehensive 28 page document lists requirements under the following main sections:
- General principles
- Principles about design and construction
Next to each requirement, a manufacturer can list the following:
- Medical Device Standards applied by manufacturer (Only if the manufacturer applied standards published as Medical Device Standard Orders or Conformity Assessment Standard Order by the TGA)
- Other standards or procedures applied by manufacturer e.g. EN; ISO; international, local standards or company procedures identified by number / title.
- Evidence of compliance or reason for non-applicability (This concerns direct reference to documents such as: study results, test reports, design outputs identified by number / title within the Quality System.
Source: TGA website