Asia/Pacific

Complaint Procedures Lacking at Beijing Polycon

Procedures for submitting medical device reports to the FDA, as well as inadequate CAPA procedures were among the numerous quality system failures uncovered during a Jan. 29 to Feb. 1 inspection of Beijing Polycon Medical Engineering’s plant in Beijing. Read More

TGA Proposes New IVD Device Regulations

Australia’s Therapeutic Goods Administration outlines a proposed new regulatory framework for in vitro diagnostic devices in a new consultation paper. Read More

Australia Rolls Out New Advertising Regulations for Devices

Australia has updated its regulations covering advertising for medical devices and the changes will take effect in January 2019. Read More

India Releases Comprehensive Reference Manual on New Medical Device Rules

India’s Ministry of Health & Family Welfare released a 241-page draft guidance to help devicemakers better understand the country’s new device rules… Read More

South Korea’s Mi Gwang Contact Lens Short-Sighted on Quality

Numerous quality system failures were uncovered at South Korea’s Mi Gwang Contact Lens Company during a March 2018 FDA inspection. Read More

Australia Rolls Out Work Plan to Engage With International Regulators

Australia’s TGA released a new work plan spelling out how it will engage with overseas regulators to increase information sharing and regulatory convergence. Read More

India’s CDSCO Wants J&J’s DePuy to Compensate Patients for Hip Implants

India’s Central Drugs Standard Control Organization is calling on Johnson & Johnson to compensate patients who suffered serious adverse events linked to the company’s ASR hip implants. Read More

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