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March 8, 2016
Ameing for Asia

Steady Improvements to Medical Device Quality in China

By Ames Gross

How CFDA enforces new regulations is critical to the future.

Continue reading →

February 8, 2016
Ameing for Asia

Exporting More Internationally? Focus On Asia

By Ames Gross

Targeting this region could expedite your company’s growth.

Continue reading →

January 12, 2016
Ameing for Asia

Booming Chinese Hospital Market an Opportunity for Device Manufacturers

By Ames Gross

Companies will soon be able to capitalize on the government’s push to encourage investment in private healthcare facilities.

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December 15, 2015
Ameing for Asia

Are Clinical Trials Needed to Register Your Device in China?

In lieu of trials, some companies may be able to submit a CER.

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November 9, 2015
Ameing for Asia

Smooth Business Operation in India is No Easy Task

By Ames Gross

Achieving success in India involves patience and a firm grasp on the culture and regulatory environment.

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October 7, 2015
Ameing for Asia

Key Regulatory Issues for Establishing New Green Field Device Factory in China

By Ames Gross

Remember, several basic regulatory approvals are required.

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September 4, 2015
Ameing for Asia

Medical Device Sourcing Trends in Asia

By Ames Gross

With prices jumping in China, Western device manufacturers and suppliers are looking elsewhere.

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August 3, 2015
Ameing for Asia

Finding Reliable Key Opinion Leaders in Asia Is Trickier Than You Think

By Ames Gross

Do your due diligence and make sure you have experienced, native boots on the ground.

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July 10, 2015
Ameing for Asia

Research Before Registration: Conducting Market Research in Asia

By Ames Gross

Before pursuing product registration in Asia, a thorough review of the market is essential.

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June 17, 2015
Ameing for Asia

The Copycat Culture in China’s Medical Device Industry

By Ames Gross

There are several steps you can take to protect your IP and avoid medical device piracy in China.

Continue reading →

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Columns

December 4, 2023
Ameing for Asia

Companion Diagnostics Regulations are Evolving in Asia

By Ames Gross
Ames Gross, Pacific Bridge Medical

Companion diagnostics (CDx) play a pivotal role in personalized medicine—one of the fastest growing areas of medicine. Regulation of CDx is fairly well established in western countries, but the east is not far behind. Here we look at current and on the horizon regulatory guidances and directives for CDx manufacturers seeking to enter the Asian markets.

April 25, 2022
Ameing for Asia

Is China Still A Good Opportunity For Device Manufacturers?

By Ames Gross
Ames Gross, Pacific Bridge Medical

The short answer is yes, but doing your homework in advance is now more important than ever.

January 21, 2022
Ameing for Asia

Medical 3-D Printing Update in Asia

By Ames Gross
Ames Gross, Pacific Bridge Medical

Increasing demand for custom surgical implants and growing investment in R&D will help the sector experience significant growth over the next five years.

November 8, 2021
Ameing for Asia

China:
A Huge Medical Device Market with Prospects and Challenges

By Ames Gross
Ames Gross, Pacific Bridge Medical

China’s medical device market has grown significantly over the last five years, but with that growth comes some pitfalls.

November 1, 2021
Ameing for Asia

Strategies You Cannot Overlook to Achieve Success in Japan’s Medical Device Market

By Ames Gross
Ames Gross, Pacific Bridge Medical

Although opportunities in Japan are still considerable, foreign device companies need to do their homework to be successful.

November 10, 2020
Ameing for Asia

Medical Devices Vulnerable as COVID-19 Deepens Cybersecurity Threats in Asia

By Ames Gross
Ames Gross, Pacific Bridge Medical

Despite the high stakes of data vulnerabilities to the entire healthcare system, governments in Asia lag behind in mandating cybersecurity measures, leaving manufacturers to install and maintain systems to protect against cyber criminals.

October 1, 2020
Ameing for Asia

Diagnostics in High Demand During Pandemic, IVD Industry Expands Footprint in Asia

By Ames Gross
Ames Gross, Pacific Bridge Medical

Fueled by an urgent need for diagnostic testing to respond to COVID-19, the in-vitro diagnostics market is experiencing explosive growth across Asia and around the globe.

September 14, 2020
Ameing for Asia

Asia 2020 Device Regulatory Update

By Ames Gross
Ames Gross, Pacific Bridge Medical

Across Asia, government health and safety authorities have tightened regulations on medical devices this year, as markets continue to experience rapid change, and as the devices themselves gain sophistication and complexity at a blistering pace.

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