Tag: ROW Regulatory News

Medical Devices – Europe, Asia and ROW Regulatory News – Aug 2025

Medical Device

AUSTRALIA TGA focuses on the compliance of AI and software-based medical devices The Therapeutic Goods Administration (TGA) is increasing its regulatory focus on software-based medical devices...

AI in medical devices, Asia medical devices, e-labeling, Europe Medical Devices, Fimea AI Act, GMP for medical devices, Health Canada guidance, Latvia e-instructions, Medical Device Regulations, ROW Regulatory News, SFDA standards, Singapore medical device pilot, South Korea biologics, Taiwan AI/ML medical devices, TGA medical devices

Pharma/Biotech – Asia, ROW Regulatory News, Nov. 2023 Vol. 2

Biopharma

ASIA MALAYSIA Revised Guideline for Facilitated Registration Pathway (FRP) Malaysia’s NPRA has updated its Facilitated Registration Pathway (FRP) guideline. The revised framework now includes...

Asia Regulatory News, BioTech, Conditional Approval, Facilitated Registration Pathway, Pharma, Regulatory Updates, ROW Regulatory News, Therapeutic Goods

Medical Devices-Asia and ROW Regulatory News-Nov. 2023

Medical Device

ASIA CHINA NMPA released Guidance Draft for comments on 54 guiding principles for registration review of Class II medical devices including the “Guiding Principles for Registration Review of...

Asia Regulatory News, Clinical Evaluation, Medical Devices, Regulatory News, ROW Regulatory News

Pharma/Biotech – Asia, ROW Regulatory News, Oct. 2023 Vol. 2

Biopharma

ASIA Pakistan DRAP outlines pharma implications of Pakistan’s hazardous waste policy The Drug Regulatory Authority of Pakistan (DRAP) has shared details about how national guidance reports...

Asia Regulatory News, BioTech, Pharma, Regulatory Updates, ROW Regulatory News

Medical Devices-Asia and ROW Regulatory News-Oct. 2023

Medical Device

ASIA INDIA The Indian Regulatory Authority (CDSCO) announced List of medical devices testing laboratory (MDTL) for carry out test or evaluation of medical device on behalf of manufacturer registered...

ANVISA, Asia Regulatory News, Medical Devices, NMPA, Regulatory News, ROW Regulatory News, SaMD, SFDA

Medical Devices-Asia and ROW Regulatory News-Sep. 2023

Medical Device

ASIA INDIA (CDSCO) India puts regulations that facilitate R&D at heart of new policy on pharma and medtech India’s Department of Pharmaceuticals (DoP) has released the National Policy on...

Asia Regulatory News, Medical Devices, Regulatory News, ROW Regulatory News, Software Based Medical Devices