MANUFACTURER’S DECLARATION OF CONFORMITY
THERAPEUTIC GOODS (MEDICAL DEVICES) REGULATIONS 2002 
made under the Therapeutic Goods Act 1989
PROCEDURES APPLYING TO CLASS 4 IN-HOUSE IVD MEDICAL DEVICES
This is a declaration of conformity made under clause 6B.6 of Schedule 3 of the Therapeutic Goods (Medical Devices) Regulations 2002 in relation to the <identify devices of the kind OR state: ‘the devices stated in the attached Schedule’>. 
*Note to applicant – if applying Full Quality Assurance procedures under Schedule 3, Part 1, use the template for the declaration made under Clause 1.6
Reference:	<If a schedule is attached, a reference to this declaration must be included in the Schedule>	
Manufacturer's name:	<Person responsible for design, production, packaging, labelling and final inspection>	
Business address:	<Address of the manufacturer>	
IVD 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 4 in-house IVD)>
	
GMDN code and term:	<GMDN Preferred term name and code; or GMDN Collective term name and code (for Class 4 IHRs);>
<OR see attached schedule for the GMDN code and term of multiple products>	
Scope of application:	<A brief description of the products to which the declaration of conformity procedures applies OR see attached schedule>	
Each kind of IVD medical device to which the quality management system has been applied complies with the applicable provisions of the essential principles; the classification rules, and these conformity assessment procedures. 
AND
<For Class 4 in-house IVD medical devices used in relation to the manufacture of blood, blood components and plasma derivatives, human cell and tissue based therapeutic goods.>
For each kind of IVD medical device<the manufacturer satisfies the requirements in the Australian Code of Manufacturing Practice for Blood and Blood Components, Human Tissues and Human Cellular Therapy Products as mentioned in subparagraph 6B.3(2)(a)(i) of the Therapeutic Goods (Medical Devices) Regulations 2002 and holds the manufacturing licence [insert licence number]> 
OR 
<the laboratory in which the kind of device is manufactured meets the requirements mentioned in subparagraphs 6B.3(2)(b)(i) and (ii) of the Therapeutic Goods (Medical Devices) Regulations 2002 and has been issued with the NATA accreditation number [insert number].>

<For Class 4 in-house IVD medical devices not used in relation to the manufacture of blood, blood components and plasma derivatives, human cell and tissue based therapeutic goods.> 
For each kind of IVD medical device, the laboratory in which the kind of device is manufactured meets the requirements mentioned in subparagraphs 6B.3(3)(a) and (b) of the Therapeutic Goods (Medical Devices) Regulations 2002 and has been issued with the NATA accreditation number [insert number].>

Authorised signatory: 
____________________________
Signature
____________________________	_____________________
Name, Position	Date
<Declaration must be signed by a person authorised by the manufacturer>