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In a draft guidance released in September 2019, Singapore’s Health Sciences Authority is seeking feedback from medical device industry stakeholders on the development of new regulations on next-generation sequencing (#NGS) #IVD devices. Read more: lnkd.in/e_sndRX

To promote the development of #convergingtechnologies, several months ago, South Korea established a government department to support the development of robotics, biological and artificial intelligence products that combine new technologies. Read more: lnkd.in/eu5wWAu

Moving to make it easier for innovative drug therapies to enter the Chinese market, the country’s National Healthcare Security Administration (NHSA) announced in August 2019 it will make 148 new drugs eligible for insurance reimbursement. Read more: lnkd.in/edMmkRX

Six months after Collategene became the first gene therapeutic drug cleared for use in Japan, the country’s health insurance system announced in September 2019 it would be placed on the list of pharmaceuticals approved for coverage. Read more: lnkd.in/eGDXGne

Stymied by what they say is overzealous regulation, India’s’ drug companies are increasingly lobbying the government to reduce oversight of clinical trials, ease limits on new pharmaceutical ventures, and reduce regulations on new drugs. Read more: lnkd.in/exnUGr6

A new free trade agreement between #Vietnam and the #EU grants foreign pharmaceutical companies the right to import drugs to this fast-growing country. Read more: lnkd.in/eyg6XqY

In Thailand, medical devices are categorized in 1 of 3 classes in accordance with the AMDD. If the applicant wants to check on the product classification, they can determine this via a new medical device classification tool. Read more: lnkd.in/eWCh7cf

Across #Asia, governments and hospitals are purchasing #robotics systems from abroad as well as developing the technologies themselves bit.ly/2CDxZrH #medtech #meddevice PBM

China’s NMPA is seeking public comments on new regulations it is drafting on drug registration, drug distribution, and manufacturing. The new regulations reflect changes made to the Drug Administration Law slated to take effect 12/1. Read more: lnkd.in/eak2VXW

Malaysia’s Medical Device Authority just revised its requirements for the labeling of medical devices. Read more: lnkd.in/eubQYHV

Regulations on in-vitro diagnostic (IVD) medical devices expected to go into effect in 2020 in South Korea will establish a broad set of registration requirements for IVDs as part of a push to improve oversight of their safety and quality. Read more: lnkd.in/eVJA6dJ

One year after Japan tightened its drug pricing system in a bid to make cutting-edge treatments more affordable, the restrictions threaten to slow drug sales to the country, a pharmaceutical industry leader warned last month. Read more: lnkd.in/ekkN_cn

Moving to bring regulatory order to its growing medical device industry and market, the Indian government has begun drafting quality and efficacy standards that would cover all medical devices sold in the country. Read more: lnkd.in/eHGbWMa

New drug therapies to treat serious and life-threatening diseases would be reviewed more quickly under draft regulations under consideration by China’s Center for Drug Evaluation (CDE). Read more: lnkd.in/ecKNZzh

Medical device manufacturers could find doing business in Malaysia more costly if new registration fees currently under consideration by the country’s Medical Device Authority (MDA) are adopted. Read more: lnkd.in/exxEDFc

South Korea is making it simpler for manufacturers to secure government approval of AI-based medical devices. In October, the Ministry of Food and Drug Safety announced that it would ease the guidelines on 154 such devices. Read more: lnkd.in/e66A2s6

Pushing to increase the ability of China’s medical institutions to conduct medical device and drug trials without sacrificing safety, the NMPA added more than 150 medical institutions to the list of those certified to host clinical trials. Read more: lnkd.in/eFb3KG5

Medical device licensing is about to get simpler in Vietnam, with the introduction of a new Ministry of Health system that allows registrants to apply for import and product licenses via a single website. Read more: lnkd.in/exrKbGM

One month after the Philippines health authorities recommended capping retail prices of 120 needed drugs, major pharmaceutical companies are in talks to reduce prices on some drugs voluntarily. Read more: lnkd.in/eFWiuQ5

The coronavirus will affect the medical supply chain coming from China. Various reports indicate that while 50% of Chinese factories are now open, only about half of these are actually producing medical products. Read more: lnkd.in/eBCb6RB