MANUFACTURER’S DECLARATION OF CONFORMITY
AUSTRALIAN THERAPEUTIC GOODS (MEDICAL DEVICES) REGULATIONS 2002
full quality assurance procedures
This is a declaration of conformity made under clause 1.8 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>	
Medical device(s):	<The unique product identifier (for example the product name or model number)>
<OR see attached schedule for multiple products>	
Classification:	<Class of device (AIMD, Class III, Class IIb, Class IIa, Class I Sterile, Class I Measurement); 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 full quality assurance procedures 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>	
Each kind of medical device to which the system has been applied complies with the applicable provisions of the essential principles, the classification rules, and the full quality assurance procedures, at each stage, from the design of the device until its final inspection before being supplied.
Full quality assurance procedures certificate:	<Certificate number for the full quality assurance procedures>
<This may include:
TGA issued conformity assessment certificate(s) – Schedule 3, Part 1- full quality assurance  system; OR
MRA conformity assessment body certificate(s); OR
European conformity assessment certificate under Annex II.3 of the Directive 93/42/EEC on Medical Devices; OR
European conformity assessment certificate under Annex 2 of the Directive 90/385/EEC on Active Implantable Medical Devices; OR
See Attached Schedule for multiple certificates>	
Design examination certificate (if applicable):	<Certificate number for the design examination procedures>
<TGA issued conformity assessment certificate(s) – Part 1, Clause 1.6- design examination; OR
MRA Conformity Assessment Body Certificate(s); OR
European conformity assessment certificate under Annex II section 4 of the Directive 93/42/EEC on Medical Devices; OR
European conformity assessment certificate under Annex 2 section 4 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