The document sets out frequently asked questions and their answers regarding the implementation of the rules on clinical trials.
More As based on Japan's Ministry of Health, Labor and Welfare notice from September 20, 2022 the Essential Principles for certain Class II medical devices are amended.
More Japan's Ministry of Health, Labour and Welfare announced that Japan's standard for medical device usability engineering (JIS T 62366-1) has been amended.
More The Medical Device Authority (MDA) updates the guideline for Licensing for Establishments. The establishment must comply to Medical Devices (Duties and Obligations of Establishments) Regulations 2019 that stipulates the post marketing requirements of medical devices. The Medical Device Authority (MDA) created this guidance document to assist the healthcare sector and the industry in their efforts to comply to the Medical Device Act's (Act 737) laws and requirements.
More PFDA issued FDA Circular No. 2022-008 that provides a guideline on the abridged process for registration of medical devices among ASEAN member countries.
More The Food and Drug Administration (FDA) announced the effectivity extension of FDA Circular No. 2021-025, a guideline for application of authorization due to extended state of public health emergency.
More During quarter 4 of 2022, Thai FDA has announced the registration certificate renewal protocol and procedures. Medical devices with specific announcements for which CSDT have been practiced under the old policy-based regulation, will expire on 31st December 2022 and shall timely proceed with license renewal accordingly.
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The OMETA/Qualtech Webinar 2022 was held on September 29, featuring updates on regulations in Asia.
More 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).
NMPA decided to start using electronic payment for drug and medical device registration fees.
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