The China Food and Drug Administration (CFDA) released a draft guidance on September 2, 2016 regarding the medical device recall process.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
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
After extreme scrutiny in the global market, the India CDSCO has begun to align India’s regulations with international standards. Previously, drugs and medical devices in India were both regulated under the Drugs and Cosmetics Act of 1940. After failing to amend the... Read More
The CFDA has required many class II and III medical device distributors to self-assess their facilities by July 15, 2016. This policy was previously applied to drug distributors in order to eliminate bad distributors and has now been expanded to include medical... Read More
Several months ago, Singapore’s Heath Science Authority (HSA) approved a revised edition of its corrective action policies for medical devices. It stated that a product may need to undergo field safety corrective action (FSCA) if product complaints and adverse incidents indicate that... Read More
Asia contains some of the world’s largest and fastest growing medical device and pharmaceutical markets in the world. The large and diverse populations found in the Asian countries makes the region an increasingly popular destination for clinical studies. There have been important... Read More