W
wangyang
Dear all:
I have noticed in the Therapeutic Goods Act , the definition of the "manufacturer" is as follows:
(1) 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
A person is not the manufacturer of a medical device if the person is included in a class of persons prescribed by the regulations for the purposes of this subsection.
From the above definition, i am not sure in the OEM mode, does the contracted manufactuer will be considered to be the manufactuer, or the OEM will be the manufactuer?
In another mode, if the manufactuer sell the medical device to an U.S distributor, then sold to the Australia market, what kind of responsibility should the U.S distributor serve as?
(2): Difference between the sponsor and the distributor.
In TGA 's regulation, i have found the definition and the responsibility of the " sponsor", however, i am not sure if there is any difference between the sponsor and the distributor. If there is more than one distributor, it seems that they all have to include the medical device into ATRG. The evidance can be found from ARGMD:
"If someone intends to supply a device that is identical to a device that is already in the ARTG, even if both devices are made by the same manufacturer, an application to include the device in the ARTG must still be made to the TGA. This is because the ARTG is not only a record of the devices that can be supplied in Australia; it is also a record of all the sponsors who are legally responsible for the medical devices on the market. "
Does it mean that every distributor should include the same medical device into the ATRG and serve as a SPONSOR in fact?
Any response will be appreciated.
I have noticed in the Therapeutic Goods Act , the definition of the "manufacturer" is as follows:
(1) 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
A person is not the manufacturer of a medical device if the person is included in a class of persons prescribed by the regulations for the purposes of this subsection.
From the above definition, i am not sure in the OEM mode, does the contracted manufactuer will be considered to be the manufactuer, or the OEM will be the manufactuer?
In another mode, if the manufactuer sell the medical device to an U.S distributor, then sold to the Australia market, what kind of responsibility should the U.S distributor serve as?
(2): Difference between the sponsor and the distributor.
In TGA 's regulation, i have found the definition and the responsibility of the " sponsor", however, i am not sure if there is any difference between the sponsor and the distributor. If there is more than one distributor, it seems that they all have to include the medical device into ATRG. The evidance can be found from ARGMD:
"If someone intends to supply a device that is identical to a device that is already in the ARTG, even if both devices are made by the same manufacturer, an application to include the device in the ARTG must still be made to the TGA. This is because the ARTG is not only a record of the devices that can be supplied in Australia; it is also a record of all the sponsors who are legally responsible for the medical devices on the market. "
Does it mean that every distributor should include the same medical device into the ATRG and serve as a SPONSOR in fact?
Any response will be appreciated.