Recently, in response to the devastating Zika outbreak in Brazil, the Brazilian Health Surveillance Agency Anvisa joined the task force Zika Zero set up by the Federal Government for the National Day of Mobilization. On Saturday Feb 13, 2016, they visited 2.8 million homes in 428 municipalities across the country. The aim was to mobilize the population for the prevention and combating of the Aedes mosquito specie, and identify its breeding sites.
Many people from across the globe have been worried due to the recent news of the Zika outbreak. According to the World Health Organization (WHO), the Zika virus has spread through both Central and South America and it is estimated that in 2016, 3 to 4 million people will be infected.
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!
In July 2013, a new mandatory medical device regulatory system came into effect in Malaysia. Manufacturers of medical devices who are planning to continue or start selling medical products in Malaysia should submit an application for medical device registration before June 30, 2016.
Technical writers and authors produce content for their companies under sever deadlines and often with little regard to the varying needs of other countries. Why take unnecessary risk?
Due to economical constraints and global requirements, more patient recruitment companies managing trials involving participants from a number of foreign countries, requiring data and information to not only be translated correctly but to be medically precise and culturally sensitive.
Mexico is the 4th largest user of Medical Device technology in the Americas. If it is a strategic target market for you, be careful; all medical devices must follow labeling requirement found in NOM-137-SSA1-2008! Labeling and instructions for use must be submitted in Spanish.
The Saudi Food & Drug Authority (SFDA) has issued new guidance on labeling requirements for medical devices approved for sale in the Kingdom of Saudi Arabia (KSA).
With international regulations for medical products becoming more rigorous, medical translation is becoming an essential component of successful product exportation and global system integration.
