Medical Device Regulation in South Africa: What's Next?

Medical Device Regulation in South Africa: What's Next?

By: Angela Gamalski.

As medical device technology expands, so does the need for regulation to assure that patients are protected from malfunctioning devices. South Africa expanded its medical device regulation, modeled on the EU’s medical device directive, just prior to the 2017 Medical Device Regulation. What does this mean for South African technology innovators?

Image credit: https://commons.wikimedia.org/wiki/File:Manual-external-defibrillator-monitor.jpg

Read More

Ending Swiss Secrecy: Switzerland's Lex FIFA

Ending Swiss Secrecy: Switzerland's Lex FIFA

By: Angela Gamalski.

Swiss authorities have traditionally had limited abilities to hold an association or corporation organized as a Swiss legal person legally accountable for bribery or corrupt acts committed by natural persons. In 2016, the Swiss criminal code "Lex FIFA" amendments became effective. Following these new laws, Switzerland should no longer a legal safe haven for associations and other corporate entities to avoid vicarious liability for the actions of that entity’s leadership.

Image credit: https://en.wikipedia.org/wiki/2014_FIFA_World_Cup_bids#/media/File:Joseph_Blatter_-_World_Cup_2014.jpg

Read More

Reforming the Japanese Health Care System

Reforming the Japanese Health Care System

By: Angela Gamalski.

Japanese law requires the government operate its national heatlh care system in a sound manner. However, economists and medical professionals have argued that the Japanese health care system is failing, as the current insurance system will not support Japan's projected demographics. Now is the time for Prime Minister Shinzo Abe to act on campaign promises and implement change.

Image credit: Japan Health Care College, by 禁樹なずな - available on Wikimedia.

Read More