TGA Allows Electronic Submissions of Device Certificates

Australia’s Therapeutic Goods Administration (TGA) has released a new method for device sponsors to apply for certificates of free sale and export electronically. Read More

Attorneys Urge Chinese Regulator to Engage More With Industry

The past year has seen a flurry of activity around China’s medical device regulations and much of the reforms have been focused on encouraging innovation while at the same time beefing up post-market enforcement. But for the reforms to be successful, the regulators should consult more with industry, according to attorneys at Ropes & Gray. Read More

Australian Wheelchair Manufacturer Failed to Report Product Defects

Magic Mobility was called out by the FDA and issued a Form 483 over MDR reporting and complaint handling practices at its Melbourne facility, including a failure to report a serious wheelchair malfunction. Read More

China Simplifies Device Registration Requirements

China’s National Drug Administration is loosening some documentation requirements for registration renewals and clinical trials to simplify compliance. Read More

Philippines FDA: J&J First Aid Kits Include Counterfeit Devices

The Philippines Food and Drug Administration issued a warning that the Johnson & Johnson First Aid To Go Kit includes devices that have not gone through the registration process and are considered counterfeit and unapproved devices. Read More

TGA Offers New Guidance on Electronic Instructions for Use

Australia’s Therapeutic Goods Administration issued new guidelines on electronic instructions for use for medical devices. Read More

South Korea Moves to Deregulate Device Industry

The South Korean government announced some deregulatory measures to accelerate device market access to boost the country’s medical device industry. Read More

FDA Issues Untitled Letter to South Korea’s Ycellbio

South Korean devicemaker Ycellbio got into hot water with the FDA for marketing its Y-PRP kit in the United States without FDA clearance and the agency issued the company an untitled letter. Read More

TGA Rolls Out New Platform for Device Advertising Complaints

Australia’s Therapeutic Goods Administration has introduced a single platform for online complaints relating to medical device advertising. Read More

China Releases New Draft Regulations for Medical Devices

China’s Ministry of Justice is seeking comments on revisions to its medical device regulations that will significantly change the environment for devicemakers. Read More