China set to relax regulations for medical device and IVD products

2019-09-11T15:29:40-04:00

On June 25, 2018, the Chinese Ministry of Justice announced amendments to the Supervision and Administration of Medical Devices Regulations (the Regulation) and called for public comment. The proposal is being celebrated by a variety of stakeholders across the medical device and IVD industry following years of lobbying to have the Regulation amended. However, some apprehension regarding the implementation of the proposed Regulation remains. Download the PDF

China set to relax regulations for medical device and IVD products2019-09-11T15:29:40-04:00

Regulatory Approvals of LDTs

2019-09-11T15:36:23-04:00

The Diagnostic Accuracy and Innovation Act (DAIA), introduced last year in the House of Representatives, would allow the Food and Drug Administration (FDA) to regulate laboratory developed tests with a new category of in vitro clinical tests (IVCTs).

Regulatory Approvals of LDTs2019-09-11T15:36:23-04:00

Digital Health Expands in Germany

2019-09-11T15:40:33-04:00

Germany has introduced two different approaches to increase digital health access for patients, providers, and health insurance companies, the Electronic Health Card Network and the Patient Accessible Electronic Health Records.

Digital Health Expands in Germany2019-09-11T15:40:33-04:00

Health Policy Insights: Germany

2019-09-11T15:41:49-04:00

Our in-market experts provide an overview of the most recent policy changes in Germany, including the government's move towards digital healthcare, revisions to evidence requirements for new medical devices, and laboratory reform.

Health Policy Insights: Germany2019-09-11T15:41:49-04:00

Policy Update: China

2019-09-11T15:43:38-04:00

On 10 July 2018, the China Drug Administration (CFDA) released a new guiding principle to allow companies to use overseas clinical trial data in their applications for new drug approvals

Policy Update: China2019-09-11T15:43:38-04:00

Policy Update: Brazil

2019-09-11T15:46:12-04:00

Introducing a new health technology or drug into Brazil’s healthcare system is a complex and interactive process involving many stakeholders, demanding in-country expertise.

Policy Update: Brazil2019-09-11T15:46:12-04:00