Definition of a Medical Device Manufacturer

Information & Training. | Medical Devices

Medical Device Regulation – Australia

Therapeutic Goods Act … Manufacturers of Medical Devices

1. The manufacturer of a medical device is the person who is responsible for the design, production, packaging and labelling of the device before it is supplied under the person’s name, whether or not it is the person, or another person acting on the person’s behalf, who carries out those operations.

2. If subsection (1) does not apply to a medical device, the manufacturer of the device is the person who, with a view to supplying the device under the person’s name, does one or more of the following using ready made products:

a. assembles the device;
b. packages the device;
c. processes the device;
d. fully refurbishes the device;
e. labels the device;
f. assigns to the device its purpose by means of information supplied, by the person, on or in any one or more of the following:

i. the labelling on the device;
ii. the instructions for using the device;
iii. any advertising material relating to the device;
iv. technical documentation describing the mechanism of the device.

3. However, a person is not the manufacturer of a medical device if:

a. the person assembles or adapts the device for an individual patient; and
b. the device has already been supplied by another person; and
c. the assembly or adaptation does not change the purpose intended for the device by means of information supplied by that other person, on or in any one or more of the following:

i. the labelling on the device;
ii. the instructions for using the device;
iii. any advertising material relating to the device.
iv. technical documentation describing the mechanism of action of the device

Information & Training.

Medical Device:

- - Validation. Classification. Regulation. Requirements. Current best practices.
  - FDA cGMP’s. EU MDR’s / MDD’s.
  - FDA Medical Device Regulation. Outline of the FDA regulatory requirements.
  - FDA Medical Device Classification. The FDA approach to Medical Device Classification.
  - EU Medical Device Regulation and Classification (per MDD’s).
  - ^New European Medical Device Regulations (MDR’s). MDR Classification. MDR General Safety requirements.
  - Current Good Manufacturing Practices. QSR’s. General requirements of the QSR’s.
  - Quality System requirements to maintain compliant Validations.
  - Medical Device Process Validation. Validation requirements. Protocol development. IQ. OQ. PQ.
  - Medical Device Software Validation.
  - Medical Device Design Validation.
  - Electronic Signature, Electronic Records.
  - Life Cycle Approach to Validation.
  - Risk Identification. Documentation. DHR’s. DMR’s.
  - Etc. Etc. …
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