MANUFACTURER’S DECLARATION OF CONFORMITY
AUSTRALIAN THERAPEUTIC GOODS (MEDICAL DEVICES) REGULATIONS 2002
DECLARATION OF CONFORMITY PROCEDURES
This is a declaration of conformity made under clause 6.6 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 (Class IIa, Class I Sterile, Class I Measurement, or Class I) OR Class 1 & Class 2 IVD>
<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 declaration of conformity 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>	
<For sterile Class IIa & Class I sterile devices>
Each kind of medical device to which the declaration of conformity procedures applies, the production quality assurance procedures have also been applied. Each kind of medical device to which the technical documentation applies complies with the applicable provisions of the essential principles, the classification rules, and these procedures.
<For non-sterile Class IIa, and non sterile Class I devices with a measuring function>
Each kind of medical device to which the declaration of conformity procedures applies, <select one conformity assessment procedure that has been applied: the verification procedures, the production quality assurance procedures; the product quality assurance procedures> have also been applied to the device. Each kind of medical device to which the technical documentation applies complies with the applicable provisions of the essential principles, the classification rules, and these procedures.
<For All Class I>
Each kind of medical device to which the technical documentation applies complies with the applicable provisions of the essential principles and the classification rules before being supplied.
For Class IIa, Class I sterile, & Class I Measurement medical devices; and for Class 1 and Class 2 IVD’s choose ONE conformity assessment procedure applied to the device and include the certificate number on this declaration	
	<Certificate number for the verification procedures>
<This may include:
TGA issued conformity assessment certificate(s)- Schedule 3, Part 3- verification procedures; OR
MRA conformity assessment body certificate(s); OR
European conformity assessment certificate under Annex IV of the Directive 93/42/EEC on Medical Devices; OR
See attached schedule for multiple certificates>
OR>	
	<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
See attached schedule for multiple certificates>
OR>	
	<Certificate number for the product quality assurance procedures>:
<This may include:
TGA issued conformity assessment certificate(s) – Schedule 3, Part 5- product quality assurance procedures; OR
MRA conformity assessment body certificate(s); OR
European conformity assessment certificate under Annex VI of the Directive 93/42/EEC on 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