This article was originally published on MedTech Intelligence. China has progressively been increasing its focus on medical innovation in recent years. China’s aging population and rise of chronic diseases make innovative medical technology crucial to delivering quality treatment to its population. Innovation... Read More
The Philippines, a Southeast Asian country made up of more than 7,000 islands, has a population of over 100 million people, making it the 12th most populous country in the world. The population grows by approximately 1.5 million people each year. The... Read More
Singapore’s Health Sciences Authority (HSA), which is administered by the Ministry of Health, plans to establish guidelines for telehealth devices. A telehealth device is any instrument, machine, or software that helps provide healthcare services through telecommunications. Under the proposed regulations, telehealth devices... Read More
This article was also published on MedTech Intelligence. Historically, Myanmar (known as Burma until 1989) has been isolated from the rest of the world. Recent political changes have, however, opened Myanmar up to the West, stimulating economic growth. In particular, the medical device... Read More
In late 2016, the Center for Medical Evaluation (CMDE) of the China Food and Drug Administration (CFDA) released the Guidance for the Management of Inquiry on Medical Technical Review. This replaces the previous Guidance for the Management of Technical Inquiry on Registration... Read More
Beginning January 1, 2017, the China Food and Drug Administration (CFDA) will be accepting priority review applications for medical devices. Eligible devices include class III devices manufactured in China and class II and III imported devices. This final decision follows the CFDA’s... Read More
In November 2016, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) reported that it has achieved the fastest median review time for new drug approvals in 2014 and 2015 among five other major regulators (US, Canada, Australia, Europe, Switzerland). In 2015, the median... Read More
The Medical Device Authority Ministry of Health in Malaysia recently released draft guidelines for “drug-medical” and “medical-drug” combination products. Previously, Malaysia lacked standards for combination product registration and regulatory requirement. Despite these draft guidelines, registering combination products in Malaysia will still take... Read More
In December 2015, over 50 countries agreed over an amendment to the World Trade Organization’s “Information Technology Agreement”. The amendment was subsequently ratified in China by the Ministry of Finance in September 2016, and allowed China to cut import tariffs on 201... Read More
In India, 90% of clinical trials over the past few years have ended abruptly primarily due to contract research organizations (CROs) and drug companies using Indian patients as “guinea pigs”. Despite this dramatic slowdown in clinical trials, the Indian government is taking... Read More