With the COVID-19 pandemic making it unsafe to conduct most on-site inspections, regulatory authorities in Malaysia are permitting remote assessments of some pharmaceutical manufacturing facilities outside the country. Malaysia’s Guidance Document on Foreign GMP Inspection, 7th edition, March 2021, published by Malaysia’s... Read More
On July 1, 2016, Malaysia’s Medical Device Authority (MDA) made it mandatory for all foreign manufacturers to register their medical device products with the MDA. These medical device registrations would be valid for 5 years, which means re-registration is now starting. Although the... Read More
Sales of diagnostic mammography equipment in the Asia-Pacific region is expected to rise significantly over the next eight years, according to two recently published studies. The reports by Globalcan and GlobalData vary in their specific findings. But both project compound annual growth... Read More
Radio Frequency Identification (RFID), a fast-developing technology that uses radio waves to collect and transfer data, is increasingly being adopted in healthcare markets across the Asia Pacific region and around the globe. A study by Precedence Research found sales of the technology,... Read More
This article was originally published on MedTech Intelligence China In China, where the vast medical device market was valued at more than $40 billion in 2019, authorities have moved to secure the safety and efficacy of medical devices while at the same... Read More
Aging populations and increased incidences of chronic diseases across the Asia-Pacific region are spurring rapid growth in demand for in-vitro diagnostic (IVD) testing. That presents major marketing opportunities for the diagnostics industry in China, India, Southeast Asia, Japan, South Korea, and Indonesia. ... Read More
The COVID-19 pandemic is hampering the initiation and progress of clinical trials in Asia and around the world. Few patients are entering studies, and trials of new treatments are on hold. In Korea, the number of new patients enrolling in clinical... Read More
Medical device manufacturers marketing their products in Malaysia will be required to report to government authorities any events related to their use that could negatively impact patient’s health, under a Medical Device Authority regulation that went into effect on July 1. The... Read More
This article was originally published on MedTech Intelligence. With the COVID-19 pandemic shuttering physician offices and walk-in clinics, patients and doctors across Asian markets have turned increasingly to telehealth solutions. The surge is creating a short-term boom—and the likelihood of a long-term... Read More