INTRODUCTION With incomes rising among its rapidly aging population of 96.7 million, Vietnam is a booming market for pharmaceuticals. Long one of the least-developed pharmaceutical markets in Asia, with relatively low per capita spending on drugs, Vietnam has tremendous potential. According to... Read More
As previously reported in February, Vietnam’s registration deadline for Class B, C, and D medical devices had been extended to January 1, 2019. Six months later, that deadline has been pushed back another year, until January 1, 2020. According to Nguyen Tuan... Read More
Seeking to quell confusion over which of its regulatory agencies has purview over medical devices that are used in combination with pharmaceuticals, Malaysia’s Medical Device Administration (MDA) has released guidelines for classifying such products. The combination products, known as Medical Device Drug... Read More
Renewing medical device registrations in China just became more simple. Moving to expedite the introduction of important new technologies to market, regulators announced this summer that they will require less documentation on sales data and post-market inspection reports from device makers seeking... Read More
For the first time in a decade, Singapore’s Health Sciences Authority (HSA) is raising the fees it charges to evaluate, register, and license medical devices. The increases, announced in August, are already beginning to take effect. Ranging from $1 to $200 per... Read More
While nearly two dozen medical devices are regulated in India as drugs, they are largely out of government price control, with only five of them subject to specific price caps. Those are cardiac stents, drug-eluting stents, condoms, intra-uterine devices, and, since last... Read More
As the pharmaceutical industry’s expansion into emerging markets meets the desire of Asian governments to speed approval of innovative products, demand for clinical trials is soaring in the Asian region. By 2021, the global market for clinical trials is expected to reach... Read More
This article was originally published on Medtech Intelligence. This article is a continuation of the two-part series on the hospital sector in Asia. Last month’s article focused on China’s hospital growth. This month’s article will expand on the status and prospects of... Read More
Last month, the China National Drug Administration (CNDA), formerly known as the China Food and Drug Administration (CFDA), released a fourth batch of Class II and III medical devices that may be exempted from the requirement to conduct local clinical studies to... Read More
South Korean health authorities are slashing the amount of time required to approve new medical devices before they can be brought to market in the country. The shorter approval period, announced on July 19 by Korea’s Ministry of Food and Drug Safety... Read More