MANUFACTURER’S DECLARATION OF CONFORMITY
AUSTRALIAN THERAPEUTIC GOODS (MEDICAL DEVICES) REGULATIONS 2002
PRODUCTION QUALITY ASSURANCE PROCEDURES
This is a declaration of conformity made under clause 4.7 of Schedule 3 to the Therapeutic Goods (Medical Devices) Regulations 2002.
Manufacturer's name:	<Person responsible for manufacturing the device>	
Business address:	<Address of the manufacturer>	
Classification:	< Class of device (AIMD, Class III or Class IIb); OR Class 3, Class 4, or Class 4 in-house IVD’s>
<OR see attached schedule for the class of multiple products>	
GMDN code and term:	<GMDN code and preferred term>
<OR see attached schedule for the GMDN code and term of multiple products>	
Scope of application:	<Products to which the production quality assurance procedure applies, this may include all OR specific or ranges of batches, lots or serial numbers, OR times of manufacture OR see attached schedule for multiple batches, lots or serial numbers>	
For each kind of medical device to which the production quality assurance procedures have been applied the type examination procedures have also been applied to the kind of device. The kind of device has been shown to conform to the approved type and that each kind of medical devices to which the system has been applied complies with the applicable provisions of the essential principles, the classification rules and the production quality assurance procedures before being supplied.
Production quality assurance procedures certificate:	<Certificate number for the production quality assurance procedures>
<This may include:
TGA issued conformity assessment certificate(s) – Schedule 3, Part 4- production quality assurance procedures; OR
MRA conformity assessment body certificate(s); OR
European conformity assessment certificate under Annex V of the Directive 93/42/EEC on Medical Devices; OR
European conformity assessment certificate under Annex 5 of the Directive 90/385/EEC on Active Implantable Medical Devices; OR
See attached schedule for multiple certificates>	
Type examination certificate:	<Certificate number for the type examination procedures>
<This may include:
TGA issued conformity assessment certificate(s) – Schedule 3, Part 2- type examination procedures ; OR
MRA conformity assessment body certificate(s); OR
European conformity assessment certificate under Annex III of the Directive 93/42/EEC on Medical Devices; OR
European conformity assessment certificate under Annex 3 of the Directive 90/385/EEC on Active Implantable Medical Devices; OR
See attached schedule for multiple certificates>	
Standards applied:	<Please give details of any conformity assessment standard or medical device standard that has been applied to the kind of medical device; OR
See Attached Schedule for multiple standards>	
Authorised signatory: <signed by the person authorised by the manufacturer>
____________________________
Signature
____________________________	_____________________
Name, Position	Date