Asia Pacific

China’s growing market for medtech, estimated at $70bn in 2021, could more than double this decade if the government’s Healthy China 2030 plan stays on track.  

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Forty-three documents have been posted on the tracker since its last update.

Researchers, research offices and ethics committees are being encouraged to familiarize themselves with the new National Statement on Ethical Conduct in Human Research before it becomes applicable on 1 January 2024.

Supreme Court finds presumption against extraterritorial reach of US laws, saying Congress never “affirmatively and unmistakably instructed” Lanham Act provisions apply to foreign conduct. Contracting with manufacturers abroad is potential pitfall for protecting trademarks, along with licensing brands to foreign marketers.

Pakistan’s drug regulator has come up with a strategy to ensure uniformity in how medical device and pharma companies disclose the money they spend on doctors and medical institutes under new ethical marketing rules.

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Fifty documents have been posted on the tracker since its last update.

A bill that will significantly reform the regulation of medicines and medical devices in New Zealand has been passed by parliament and will soon become law, but the pharmaceutical and medtech industries have reservations about some of its provisions.

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Forty-one documents have been posted on the tracker since its last update.

Panelists at DTA’s 2023 Inaugural Summit explored the landscape of DTX regulations across the world.

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Forty-seven documents have been posted on the tracker since its last update.

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 30 documents have been posted on the tracker since its last update.

Given that it is now possible to produce individualized medical devices on a commercial rather than an artisanal scale, new measures are needed to keep up with the changing level of risk to patients.

A series of stories from the Healthcare Information and Management Society's 2023 Global Health Conference.

Only those countries signed up to the International Medical Device Regulators Forum are automatic members of the new global communication system for risky devices and IVDs.

Companies should avoid focusing only on the positive qualities of a therapeutic good or omitting or downplaying the negative qualities such as possible side effects, according to new guidance on therapeutic goods advertising and Australian Securities Exchange announcements.

Digital data capture is rife now in the medtech sector. What needs to be done at an international level to control and optimize its use and that of real-world evidence based on this data? Do initiatives that came up at the International Medical Device Regulators Forum offer solutions to prevent potential global chaos?