In December 2015, over 50 countries agreed over an amendment to the World Trade Organization’s “Information Technology Agreement”. The amendment was subsequently ratified in China by the Ministry of Finance in September 2016, and allowed China to cut import tariffs on 201... Read More
On September 30, 2016, the China Food and Drug Administration (CFDA) published an update to “Exemption list of Class II and Class III devices for local clinical study”. Following the May 2016 release of the original list, there are now a total... Read More
In India, 90% of clinical trials over the past few years have ended abruptly primarily due to contract research organizations (CROs) and drug companies using Indian patients as “guinea pigs”. Despite this dramatic slowdown in clinical trials, the Indian government is taking... Read More
The China Food and Drug Administration (CFDA) released a draft guidance on September 2, 2016 regarding the medical device recall process. These new measures significantly expand on the current regulations released by the CFDA in 2011. The original regulations defined defective devices as ones that may endanger human health, and focused on... Read More
The China Food and Drug Administration (CFDA) released draft rules in June 2016 proposing a priority review pathway for certain medical devices. In 2014, the CFDA released an expedited pathway for “innovative” devices, which is similar to but different from this “breakthrough” pathway. Applicants with devices... Read More
This article was also published on MedTech Intelligence. 3-D printing has revolutionized product customization and digital manufacturing in various industries. In many instances, it is not only faster and less expensive than alternative manufacturing methods, but also numerous types of material can be... Read More
Recently, the CFDA published a new draft of the Provisions for Drug Registration for public comment. The new provisions updated the document from the 2007 version by changing Market Authorization Holder (MAH) regulations, improving the application approval process, and lessening provincial level... Read More
For many years, India’s clinical trials have been under international scrutiny. India’s global clinical trials have had many problems, such as unethical treatment of subjects, failure to compensate patients for serious adverse events, and lack of adherence to India’s clinical trial regulations... Read More
Vietnam’s National Assembly recently approved a new Pharmacy Law that will be fully implemented in 2017. It will eliminate the country’s current clinical trial requirement for drugs, along with other changes. Currently, Vietnam’s clinical trial requirement has led to a shortage of... Read More
In 2016, the Quality Council of India (QCI) announced the Indian Certification for Medical Devices (ICMED) system, India’s first quality assurance system for medical devices. ICMED will aim to improve patient safety and consumer protection in order to fix the persistent problems... Read More