Tag Archives: China

Ameing for Asia

Hopes and Hurdles for Medical Device Companies in China in the Year of the Ram

By Ames Gross

There are great opportunities for foreign medical device companies in China as the people want better healthcare, the government is increasing access to healthcare, and the market is growing between 15 and 20 percent per year. But access to the marketplace is harder than ever. Why?

There are great opportunities for foreign medical device companies in China as the people want better healthcare, the government is increasing access to healthcare, and the market is growing between 15 and 20 percent per year. But access to the marketplace is harder than ever. Why?

Continue reading

New User Fees Set for Foreign Medical Device Manufacturers in China

Chinese medical device market regulator China Food and Drug Administration (CFDA) has published a draft table of user fees for medical device registrants, and is expected to begin enforcing fee requirements in March 2015.

Chinese medical device market regulator China Food and Drug Administration (CFDA) has published a draft table of user fees for medical device registrants, and is expected to begin enforcing fee requirements in March 2015.

Continue reading

The Key to Successfully Selling Medical Devices in China and Japan – Good Distributors

By Ames Gross

One of the best ways for small and mid sized Western device firms to take advantage of these growing markets is to conclude agreements with reputable, trustworthy, and well connected medical device distributors located there.

One of the best ways for small and mid sized Western device firms to take advantage of these growing markets is to conclude agreements with reputable, trustworthy, and well connected medical device distributors located there.

Continue reading

Worldwide Medical Device Regulatory Updates

By Stewart Eisenhart

As medical device quality assurance and regulatory affairs professionals, it can be challenging to stay on top of changes happening in our industry. Below are some updates of recent regulatory changes in the medical device and IVD industry from around the world, compiled by The Emergo Group.

As medical device quality assurance and regulatory affairs professionals, it can be challenging to stay on top of changes happening in our industry. Below are some updates of recent regulatory changes in the medical device and IVD industry from around the world, compiled by The Emergo Group.

Continue reading