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Medical Devices-Regulatory Updates-Asia Round Up-Jul 2021

Medical Device

Malaysia (MDA) 1. Updated Guidelines for Testing Medical Face Masks by Malaysia’s MDA In response to the COVID-19 pandemic, the Medical Device Authority (MDA) of Malaysia has revised its...

Serotonergic Anti-depressants for Depression in Pregnant Women

Medical Device

New Zealand’s Medicines and Medical Devices Safety Authority (MEDSAFE) has published few takeaways pertaining to the new minimal risk of postpartum haemorrhage with the consumption of certain anti-depressants...

benefits of treating depression for mother, minimal risk of postpartum hemorrhage, new minimal risk of postpartum, Serotonergic Anti-depressants

Adverse Reaction Reporting Guide for New Zealand

Standards

New Zealand maintains one of the highest global reporting rates for adverse reactions to medicines. The Centre for Adverse Reactions Monitoring (CARM) in Dunedin serves as the national repository for...

adverse drug reactions, centre for Adverse Reactions monitoring, guide for adverse reaction reports, pharmacists.

Unique Device Identification System

Medical Device

The FDA’s Unique Device Identification (UDI) system was established to ensure that medical devices distributed in the United States can be accurately identified from manufacturing through distribution...

FDA requires medical device labelers, GUDID, Medical Devices, Medical Devices Labeling, UDI, Unique Device Identification System

Labeling Requirements for Prescription Drugs

Digital Health

Under FDA there are more than 150 labeling resources that are present for labeling prescription drugs. FDA has approved about 50+ guidances to be used while labelling cartons and containers containing...

EU Regulations: Things Still to be known

Medical Device

Medical Device Regulations (EU) 2017/745 is an advancement that would help EU in coping with medical science changes. Manufacturers will regard the new regulations as a benchmark globally as it would...