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Global Medtech Guidance Tracker: February 2024
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Thirty-six documents have been posted on the tracker since its last update.
Global Medtech Guidance Tracker: January 2024
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.
FDA Revises Guidance On RRAs With Updated Q&As
The FDA has revised draft guidance issued in 2022 on how the agency plans to continue using remote technology to assess regulated facilities. The FDA established remote assessments in early 2021 to keep up its regulatory obligations during the COVID-19 pandemic.
Global Medtech Guidance Tracker: December 2023
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 50 documents have been posted on the tracker since its last update.
FDA Evaluating Safety Of Plastic Syringes From China, May Prevent Their Import To The US
The US FDA is advising the public that certain plastic syringes from China could fail, leak, or break. If necessary, the agency may prevent Chinese syringes from entering the US.
Global Medtech Guidance Tracker: November 2023
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.
FDA Leaves Global Harmonization Working Party, Will Focus International Harmonization Efforts
Three years after joining, the US FDA announced its withdrawal from the Global Harmonization Working Party and intention to focus its work on medical device harmonization through its collaboration with the International Medical Device Regulators Forum.
Global Medtech Guidance Tracker: October 2023
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Forty-five documents have been posted on the tracker since its last update.
Global Medtech Guidance Tracker: September 2023
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.
China: Value-Based Procurement Reshapes Strategies Of Multinational Medtech Firms
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.
Global Medtech Guidance Tracker: August 2023
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.
‘Significant Changes’ To Research Ethics Review Rules In Australia Include New Risk Model
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 Decision Makes Partnerships With International Manufacturers More Crucial For US Firms
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 Acts To Harmonize Disclosure Of Medtech Payments To Doctors
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.
Global Medtech Guidance Tracker: July 2023
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.
New Zealand Passes Bill To Overhaul Drug And Device Regulation
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.
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