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AUSTRALIA: Use of Market Authorisation Evidence from Comparable Overseas Regulators / Assessment Bodies for Medical Devices (including IVDs) - October/November 2022

AUSTRALIA: Use of Market Authorisation Evidence from Comparable Overseas Regulators / Assessment Bodies for Medical Devices (including IVDs) - October/November 2022

  • 2022-10-25 07:32:01

In Australia, the “Use of market authorisation evidence from comparable overseas regulators / assessment bodies for medical devices (including IVDs)” and the “Reduction of Assessment Fees for Medical Devices Guideline”, both outline specific situations in which the assessment procedures and the assessment costs for medical devices may be reduced.
The guideline provides details on the criteria and the eligibility for TGA to determine whether the process can be reduced for application audit assessments and conformity assessments involving medical devices (including IVDs).

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BNO Promotion:  Quickly Establishing your UDI Management System via WhaleTeq's UDIBar – A UDI Generator and Label Management System

BNO Promotion: Quickly Establishing your UDI Management System via WhaleTeq's UDIBar – A UDI Generator and Label Management System

  • 2022-07-26 10:43:03

Given the international trend of more and more authorities requiring the implementation of Unique Device Identification, such as by US FDA, via the new European MDR, as well as by Taiwan FDA, Qualtech would like to share with our readers a useful tool to help you establish your UDI management system. That is, via the UDI Generator and Label Management System called "UDiBar" by WhaleTeq.

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AUSTRALIA:  Auditing of Medical Device Applications, including IVD Medical Devices – February, 2022

AUSTRALIA: Auditing of Medical Device Applications, including IVD Medical Devices – February, 2022

  • 2022-02-18 07:40:24

Application audit may be conducted during the procedure of inclusion of a medical device in the Australian Register of Therapeutic Goods (ARTG). In some applications, audit may be selective under the legislation, however, others may be selected for an audit at the discretion of the delegate. Here we list out the devices that require mandatory auditing under Regulation 5.3. To conclude, a summarised view of the audit process will be provided.

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USA: Post-Approval Studies Program

USA: Post-Approval Studies Program

  • 2021-04-26 02:48:33

In order to ensure the safety and effectiveness of medical devices, the FDA has the Post-Approval Studies Program for 3 kinds of applications. There are Premarket Approval (PMA), Humanitarian Device Exemption (HDE), and Product Development Protocol (PDP). Applicants for these categories should follow the conditions from Post-approval studies to maintain product legality.

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USA: 522 Postmarket Surveillance Studies Program

USA: 522 Postmarket Surveillance Studies Program

  • 2021-04-26 02:44:41

The Center for Devices and Radiological Health (CDRH) has established an internal tracking system for 522 postmarket surveillance studies, where each product applicant can view the status and timeline of their products when the FDA requires the 522 postmarket surveillance study.

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