SQA

FEBRUARY 15, 2023

A new template for the Certificate of a Pharmaceutical Product will be put into use in line with China’s pharmaceutical export practices and the latest World Health Organization (WHO) guidelines. China’s drug MAH system has been implemented nationwide since the revised Drug Administration Law came into force in 2019.

US Department of Health and Human Services 40

US Department of Health and Human Services FDA COVID-19 World Health 40

SQA

OCTOBER 18, 2023

Time frame for Accepting CE Marked Medical Devices in Great Britain Extended, 01 July 2023 The United Kingdom (UK) government has made regulations ( The Medical Devices (Amendment) (Great Britain) Regulations 2023 ) that enable CE marked medical devices to be accepted in Great Britain for defined periods beyond 30 June 2023.

FDA 40

FDA Compliance Licensing World Health 40

SQA

FEBRUARY 26, 2024

This guidance does not intend to elaborate on aspects related to the clinical evaluation or cybersecurity for these products, as those are described in other guidelines ( MDCG 2020-1 on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software; MDCG 2019-16 on Cybersecurity for medical devices).

FDA 52

FDA Compliance COVID-19 Public Health 52