Vietnam

Warning letters to SuXiang Medical Instrument in China and Yahon Enterprise in Vietnam among recent warnings FDAS sent to OTC drug and supplement manufacturers, including a Florida firm, White Label Leaf, warned about selling gummies containing delta-8 THC, and other OTC skin care product firms.

Rising Leader Jing Lim is part of the team getting 3D implant and bone regenerating innovator Osteopore better known outside its founding base in Singapore. The company stands on the cusp of accelerated growth on the back of an expanding portfolio and its best practice approach to business building.

Vietnam’s medtech industry breathed more easily when the new decree, 98/2021, became the regulatory instrument for the sector on 1 January. While its practical approach to industry’s needs was welcomed, new price and profit declaration demands will be harder for companies to swallow.

Novartis has expanded its efforts to help low- and lower-middle-income countries “mitigate the impact of the pandemic and support healthcare systems,” after signing a memorandum of understanding with Vietnam’s Ministry of Health providing various treatments for COVID-19 at-cost.

The US FDA says it’s “investigating certain imported medical gloves that appear to have been reprocessed, cleaned, or recycled and sold as new.” The 270 firms in question are listed on an import alert that says their gloves are subject to Detention without Physical Examination.

Here’s the complete list of foreign firms that were included on an import alert because gloves they made or sold may have been “reprocessed, cleaned, or recycled and sold as new,” the US FDA says.

The latest Asian Regulatory Discussions heard about Malaysia’s five-year device certificate renewal concerns, Vietnam industry’s suggestion for device fast-task approval routes, and the Philippines industry’s transition needs as the country’s new AMDD-based regulatory system gets up and running. Also: device news from Singapore and Thailand.

Vietnam’s pharma market has seen constant growth over the last decade, driven by rising incomes and an aging population. Spending on drugs is expected to rise by more than 10% in 2021.

Survey of more than 5,000 Asia-Pacific consumers finds 56% use technology tools such as nutrition apps to support healthy living, suggesting opportunity to connect with consumers.

RAAS Nutritionals tells FDA “it proceeded without an IND because it believed that if it was legally able to sell its nutritional supplements ... it should be able to test and observe the effects of those supplements without an IND.”