manuf-forms-conformity-assessment-certificates-p21
Document Sample
Attachment 3: Recertification checklist
Note: Copy this section for each kind of medical device as defined by the Therapeutic
Goods Act 1989, Section 41BE.
An additional copy of the supporting data in electronic format (in Word or PDF format) may
assist the TGA with the assessment.
Quality system documentation Supplied Data location
Essential principles checklist supplied Y N Enter location.
<http://www.tga.gov.au/industry/devices-forms-essential- (e.g., vol.1, section 3, p.10)
principles-checklist.htm >
Note: Please include a separate Essential Requirements
checklist (as per the MDD) if applying for EC Certification.
Review of risk management file for currency and Y N Enter location.
relevance, including current copy of risk (e.g., vol.1, section 3, p.10)
management report
(as per clause 8 of ISO 14971)
Details of all changes that have occurred since Y N Enter location.
certification (e.g., vol.1, section 3, p.10)
(incl. to quality manual, suppliers, production processes)
For all devices (excluding IVDs) containing medicinal Applicable Y N
substance(s)
Supplied Data location
Details of all changes that have occurred since Y N Enter location.
certification (e.g., vol.1, section 3, p.10)
For all devices (excluding IVDs) containing material of Applicable Y N
animal, microbial, recombinant origin
Supplied Data location
Details of all changes that have occurred since Y N Enter location.
certification (e.g., vol.1, section 3, p.10)
For all sterile devices (excluding IVDs) Applicable Y N
Supplied Data location
Details of all changes that have occurred since Y N Enter location.
certification (e.g., vol.1, section 3, p.10)
For each device Supplied Data location
Concise summary of all new products since Enter location.
certification Y N (e.g., vol.1, section 3, p.10)
Concise summary of all design and production Y N Enter location.
changes to each device since (e.g., vol.1, section 3, p.10)
certification
Detailed description of any safety related design or Y N Enter location.
production changes (e.g., vol.1, section 3, p.10)
(e.g., in response to adverse event or recall)
Conformity assessment certification—Supporting data form (Version 2011-08-25)—Attachment 3 Page 1 of 3
Details of any changes to the intended purpose of Y N Enter location.
any device (e.g., vol.1, section 3, p.10)
Summary of any changes to product labelling and Y N Enter location.
instructions for use since certification (e.g., vol.1, section 3, p.10)
List of all devices to not be recertified Y N Enter location.
(e.g., vol.1, section 3, p.10)
For each device, a concise summary of post-market
Supplied Data location
performance data including
adverse events (Australia and other countries) Enter location.
Y N (e.g., vol.1, section 3, p.10)
recalls and alerts (Australia and other countries) Enter location.
Y N (e.g., vol.1, section 3, p.10)
review of new clinical literature since certification Enter location.
Y N (e.g., vol.1, section 3, p.10)
review of significance of new safety and Enter location.
performance standards since certification Y N (e.g., vol.1, section 3, p.10)
summary of any new clinical trial data Enter location.
Y N (e.g., vol.1, section 3, p.10)
summary of any other clinical data Enter location.
Y N (e.g., vol.1, section 3, p.10)
(e.g., customer surveys)
approvals in other regulatory jurisdictions Enter location.
Y N (e.g., vol.1, section 3, p.10)
Has any device in this application been rejected for approval, or the
application been withdrawn from any other regulatory authority or body? Y N
If yes, provide location of the details Enter location.
(e.g., vol.1, section 3, p.10)
Has any device in this application been withdrawn from any market around
the world? Y N
If yes, provide location of the details Enter location.
(e.g., vol.1, section 3, p.10)
Conformity assessment certification—Supporting data form (Version 2011-08-25)—Attachment 3 Page 2 of 3
Any other substantial change since certification not mentioned above Applicable Y N
Description of change relating to manufacturer, supplier or Quality
Management System (QMS) Data location
Enter description of each change. Enter location.
(e.g., if the change affects the manufacturer details, the manufacturer facilities, the (e.g., vol.1, section 3, p.10)
suppliers or subcontractors, or the quality management system)
Description of change relating to the scope of a Schedule 3, Part 1, 4
or 5 certificate
Enter description of each change. Enter location.
(e.g., if the intention is to extend the scope of a Schedule 3, Part 1, 4 or 5 certificate to (e.g., vol.1, section 3, p.10)
add new GMDN codes, or for the introduction of substantial changes to products under
a GMDN category)
Description of change relating to the design, material, product or
indications
Enter description of each change. Enter location.
(e.g., if the change affects the design, indications, etc. of a UPI (unique product) (e.g., vol.1, section 3, p.10)
covered by a Schedule 3, Clause 1.6 or a Schedule 3, Part 2 certificate but it does not
result in a new UPI)
Details of previous correspondence with the TGA regarding the Enter location.
application (e.g., vol.1, section 3, p.10)
Conformity assessment certification—Supporting data form (Version 2011-08-25)—Attachment 3 Page 3 of 3
