1. Medtech Insight
  2. >>Policy & Regulation
  3. >>Regulation

China Widens MAH Scheme To Medtech As Consumables Face Price Cuts

 
• By Brian Yang

China is quickly expanding its marketing authorization holder scheme from drugs to devices. It is also vowing to reduce medical costs by using more low-cost, domestic consumables, which will have a significant impact on companies.

EU Chamber of Commerce in China president Jorg Wukket speaks at March 7 press briefing in Beijing, China.
CHINA MANUFACTURING 2025 IS AIMED TO ENCOURAGE MADE IN CHINA MEDICAL PRODUCTS • Source: Medtech Insight

China's marketing authorization holder mechanism is now being expanded to the medtech sector, and from the original four mega cities to 21 provinces, including the major medtech-producing provinces, Jiangsu, Zhejiang and Shandong.

International device makers can also leverage the MAH mechanism, which is a method of contracting manufacturing to local companies, which...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Regulation

New EU Rules Limit Chinese Participation In Medtech Procurement

 
• By Amanda Maxwell

From June 30, new European Commission rules will attempt to redress an imbalance in medtech trade between the EU and the People’s Republic of China.

FDA Regulations ‘Lock Out’ Clinically Proven Neuromodulation Devices

 
• By Natasha Barrow

Flow Neuroscience's neuromodulation headset for the treatment of depression is approved and marketed in the EU. However, two years on, the company is still waiting for US FDA approval despite being assigned breakthrough device designation.

Guidance Details EU Approach On Medtech, AI Regulation Interplay

 
• By Amanda Maxwell

Overlapping clinical testing requirements and decision-making around significant changes to MDAI are among the tricky subjects that the new document explains.

UK MHRA Joins New Global Network For Safe Use Of AI In Healthcare

 
• By Natasha Barrow

The UK's regulatory agency is the first to join a new international network for oversight of AI in healthcare run by a non-profit organization, HealthAI, the global agency for responsible AI in health.

More from Policy & Regulation

UK Trails NHS 10-Year Plan With Launch Imminent

 
• By Ashley Yeo

Healthcare product industries await publication of the NHS 10-Year Plan, due out the coming days, which will focus on health generally not just the NHS, UK health secretary Wes Streeting said during a final prelaunch event on 24 June.

New EU Rules Limit Chinese Participation In Medtech Procurement

 
• By Amanda Maxwell

From June 30, new European Commission rules will attempt to redress an imbalance in medtech trade between the EU and the People’s Republic of China.

Mexico’s New Procurement Rules Aim To Increase Healthcare Investment, But May Face Legal Trouble

 
• By Francesca Bruce

Legal experts warn, however, that new Mexican procurement rules are discriminatory and could be challenged in the courts.