Important Regulatory changes in Australia

A

arios

#1
Team:

I just received this notification which I found worth sharing here at the cove. Actually I am just copying a portion because there was some publicity related involved, so I tried to keep only the part w/o such commercial claims:

"We are writing to communicate three important changes to the Australian medical device and IVD regulatory landscape. Each of these items will be discussed in greater detail in the sections we’ve outlined below. They include:

1. IVDs are now regulated by the Australian Therapeutic Goods Administration (TGA)

2. Extensive new TGA guidance on medical devices has been issued
3. The process of changing Australian Sponsors has been simplified

TGA Regulates IVDs effective 1 July 2010
IVDs will now be regulated by the TGA. Though the Therapeutic Goods (Medical Devices) Amendment Regulations 2010 and the Therapeutic Goods Amendment Regulations 2010 were issued on 25 February 2010, the changes will be implemented on 1 July 2010. These regulations amend the Therapeutic Goods (Medical Devices) Regulations 2002 and the Therapeutic Goods Regulations 1990. The major changes pertain to the currently largely unregulated in-vitro diagnostic devices (IVDs). The greatest implications of which include IVD classification based on risk and the first regulatory implementation of GHTF IVD Guidance.

To this end, the new classification of IVDs has been transposed from the GHTF to consist of Classes 1, 2, 3, and 4 in increasing order of risk. Further, the new regulations require that all IVDs be registered in the Australian Register of Therapeutic Goods (ARTG) prior to sale after 1 July 2010. Those products which are currently on the market and not in the ARTG, (as they were previously considered unregulated) will have until 2014 to do so; thus providing a four year transition period. For these products eligible for the four year transition period, it is our understanding (based on communication with the TGA) that documents proving that the product had been sold or advertised prior to 1 July 2010 may constitute evidence of supply. The 1 July 2010 implementation date applies only to IVDs that are new to the market."
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
L Which one is more important for FMEA CC or SC, FMEA and Control Plans 6
D What are the important things to keep track of in product audit checklist? Software Quality Assurance 3
JoshuaFroud How important is using the "correct" GMDN? Other Medical Device Regulations World-Wide 14
B The most important criteria of IEC 60601-1 medical devices safety IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
M How important is a Quality Manual - ISO 9001:2008 to 9001:2015 Quality Management System (QMS) Manuals 95
R Which of the following indicators is important for Operations - Ppk, Cpk, or Cpm? Statistical Analysis Tools, Techniques and SPC 15
B How important it is to select Parts that represent the Process Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
T Is a Job Title important? Career and Occupation Discussions 28
M Important procedures and clauses for company which provides equipment rental Service Industry Specific Topics 1
somashekar Link to important websites within the Cove Book, Video, Blog and Web Site Reviews and Recommendations 1
M Accountability for all product - Why it is important? Intent of 7.5.1 g) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
E How important is External Verification of Corruption Prevention Programs? Sustainability, Green Initiatives and Ecology 2
J Late CA (Corrective Action) excuse or I'm too important or no response Nonconformance and Corrective Action 19
G How important is using the current QCI study primer revision for preparation Professional Certifications and Degrees 1
A What is more important - Head office OR Factory? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
A Can a project have multiple Ys that are interrelated and important to the process? Six Sigma 5
H Beautiful, Graphic, Process Map examples wanted - Graphic design is important Process Maps, Process Mapping and Turtle Diagrams 7
G Short TQM training - Choosing of most important points Training - Internal, External, Online and Distance Learning 3
D An important travel tip Imported Legacy Blogs 4
O I need a process map for ISO 9001 important processes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
M The 3 Most Important Tips to Starters Implementing a QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 25
A Most Important Knowledge in the Quality Assurance field - What to Learn Career and Occupation Discussions 11
Q What are the most important documents to maintain with your audit package Internal Auditing 15
Jim Wynne Why it's important to have clear specifications Funny Stuff - Jokes and Humour 2
M What are the most Important Areas that Concern the External Auditors ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
A Is Accreditation of Auditor Training Important? Training - Internal, External, Online and Distance Learning 29
S Are Teeth Important in Making Good First Impressions? Coffee Break and Water Cooler Discussions 31
S Why historical data & benchmark data is important in APQP planning phase APQP and PPAP 6
Statistical Steven Accuracy vs. Precision - What is more important for Process Capability Statistical Analysis Tools, Techniques and SPC 55
R TQM Project - Books on important TQM books The Reading Room 5
N Is safety in chemical industry an important requirement to be ISO certified? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 20
W How important the QMS could be in our work - Seeking presentation for colleagues ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
D "Shop-Floor Work Instruction" ? How important they are? Manufacturing and Related Processes 11
Marc Which is more important to a Quality Professional - MBA or Six Sigma Black Belt? Professional Certifications and Degrees 44
C IATF Guidance for TS 16949:2002 - Course Instructor says it's important ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 5
Y Why are the principles of controlled documentation important to a QMS? Document Control Systems, Procedures, Forms and Templates 2
A Decreasing our Ppm! Important and effective point to decrease ppm level Statistical Analysis Tools, Techniques and SPC 10
W Is Training Important to Your Organization? Training - Internal, External, Online and Distance Learning 22
J Industry codes: how important? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
G Quality Culture - Teaching Quality is as Important as Safety Other ISO and International Standards and European Regulations 7
S Quality Objectives. What? How? And How important to the organization? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
M Quality not Important for British Companies Misc. Quality Assurance and Business Systems Related Topics 6
S What is the life cycle costing? Why so important? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
C Is calibration of digital panel important in any semicon company? General Measurement Device and Calibration Topics 3
Z Linearity of Bias in MSA - Why is it important? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
ebrahim QMS as per ISO 13485, Clause 4.2 Requirements for regulatory purposes for Medical Devices Authorized Representatives. ISO 13485:2016 - Medical Device Quality Management Systems 3
A Reliable sources for following EU medical device regulatory EU Medical Device Regulations 0
A GPS Regulatory requirements? Manufacturing and Related Processes 6
C RA (Regulatory Assurance) Training (FDA) looking for resources Training - Internal, External, Online and Distance Learning 5
H SOP Template for seeking regulatory clearance - MDSAP Document Control Systems, Procedures, Forms and Templates 6

Similar threads

Top Bottom