JD Supra

Overview of Medical Device Regulation in China

How is the manufacturing, marketing, distribution, and sale of medical devices regulated in the People’s Republic of China? This article outlines the regulatory framework and pathways, the ...
JD Supra

China Widens Entry to Medical Device Market to Investment, Innovation While Tightening Regulations on Existing Market Products

As the medical device industry in China continues accelerated growth, investors seek to capitalize on a roughly $65 billion market that is growing at an annual rate of 21 percent. Under recent changes ...
Nasdaq

InnerScope Hearing Technologies (OTC: INND) Completes FDA Class II Medical Device Registration for its Hearing Aid Devices

InnerScope has completed the FDA Medical Device Registration for Class II Hearing Aid, Air Conduction with Wireless Technology, and is preparing for the Launch of its Latest in Direct-to-Consumer ...
HealthTech

MDR Medical Device Regulations: A Safety Net or Too Much Restriction?

The European Union’s Medical Device Regulation (MDR) is a complex regulatory framework created to put in place rules and requirements in how medical devices are designed, manufactured, and marketed.
FierceBiotech

UPDATED: China FDA's new medical device importation regulations shorten review period

Whether China unfairly discriminates against foreign companies is always a subject of controversy and debate. In the case of the medical device industry, the Chinese government has started encouraging ...
Nasdaq

China’s NMPA Approved Starting of Registration Testing of AnPac Bio Class III Medical Device (For Lung Cancer Auxiliary Diagnosis Utility)

SAN JOSE, Calif., Feb. 08, 2021 (GLOBE NEWSWIRE) -- AnPac Bio-Medical Science Co., Ltd. (“AnPac Bio,” the “Company” or “we”) (ANPC), a biotechnology company with operations in China and the United ...