Pharmaceutical products cost companies billions of dollars to develop, numerous years of clinical trials and ample red tape to win the approvals of international regulatory bodies. Finalizing the packaging and inserts should take into considering the local requirements for each of the countries it will be sold into.
On November 23rd, 2015, the U.S. Department of Commerce released its Fact Sheet on the 26th U.S.-China Joint Commission on Commerce and Trade. The fact sheet spelled out great news for the Pharmaceutical and Medical Device industries regarding regulatory requirements for entering the Chinese market.
Today, software is ubiquitous. Companies in Life-Science industries have awakened to the benefits of incorporating software into their products to add features, make them configurable or facilitate their use. Since the Medical Device Directive from the European Community, 2007/47/EC, they’ve had to localize their software to be able to sell products in the EU.
Medical Devices take many years to get developed, debugged, perfected and approved by regulatory bodies around the world. Once approved, Medical Device manufacturers and their investors seek to capitalize on their investment by expediently entering as many markets as they can! Meet Simultaneous Releases!