China has a new medical device classification catalog: what you need to know

Grace Fu Palma, China Med Device The China Food and Drug Administration (CFDA) recently unveiled its new “Medical Device Classification Catalogue” – which has significant implications for medical devices registrations or renewals. The new catalog, announced Aug. 31 after a previous draft release and feedback period, goes into effect in less than a year – on Aug. 1, 2018.

China wants to dominate medtech: Here’s how

Under its “Made in China 2025” plan, the Chinese government seeks explosive growth in biomedical and high-end medical device manufacturing. Grace Fu Palma, China Med Device In 2015, the China State Council issued a 10-year manufacturing plan called “Made in China 2025.” The  goal is to elevate the “giant but weak” Chinese manufacturing industry into

China FDA issues draft guidance on clinical evaluation of some IVD reagents

Grace Fu Palma, China Med Device China FDA recently issued a draft guidance document on clinical evaluation basic requirements for clinical exempt IVD reagents, along with a second batch of clinical exempt class II IVD reagents – 130 reagents – to the agency’s directory. Key provisions in the draft, issued May 24, deal with the

Tekni-Plex announces new $15 million China manufacturing facility

Tekni-Plex said today that it has invested $15 million in a new state-of-the-art manufacturing facility near Shanghai, in Suzhou, China. The new facility is meant to meet the growing needs of the Asia-Pacific medical device and pharmaceutical market, according to Wayne, Pa.–based Tekni-Plex. Some production is already underway at the more than 140,000-square-foot facility. Tekni-Plex is

Why U.S. first may be the new medical device development strategy

Increased regulatory hurdles in Europe and China could mean more medical device development focusing on the U.S. market first. That seemed to be a major takeaway from panels on regulation and reimbursement at Healthegy’s Medtech Conference, held last week in Minneapolis. “We’re actually going to be doing more early clinical work with the FDA,” said Stacey Pugh, vice

China regulators formalize procedures for medical device expert panel meetings

By Stewart Eisenhart, Emergo Group Regulators at the China Food and Drug Administration (CFDA) have published formal procedures for expert panel meetings held to discuss medical device registration issues, clarifying the process for Chinese market applicants. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the

China FDA clarifies device recall requirements

By Stewart Eisenhart, Emergo Group Chinese medical device market regulators have made reporting forms necessary for recall management available online. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of or its employees.

Qosina establishes trading company in China

Qosina has established a wholly owned Chinese entity called Qosina Trading Co. Located in Shanghai, the Qosina Trading Co. office provides customers the benefit of delivering goods manufactured in China directly to their operations in China, reducing or eliminating related logistics and customs expenses. Along with local partner for distribution, HNG Medical, Qosina can better serve

China FDA getting rid of medical device testing fees

By Stewart Eisenhart, Emergo Group The China Food and Drug Administration (CFDA) appears to have stopped charging substantial fees for in-country registration testing of medical devices. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of

Jade Group International expands China operations

Jade Group International—a global provider of tooling and manufacturer of plastic parts and components to medical device makers and other industries—has announced an expansion of its China operations in response to growing demand for its products in North America, Canada, and Europe. In December, the company moved its tooling operation into a new 1600-sq-meter leased

Medtec Report: China increases focus on med device development

Regulators in China are looking to promote and increase the localization and development of medical devices in the region and grow the market significantly, according to a report from industry group Medtec. China released its 13th 5-year health strategy plan, drawing a bead on medical devices as a “main breakthrough area” for the country, according to

Ginolis opens first Asia Pacific office in China

Ginolis has opened its first Asia Pacific office in Suzhou, China. As a global provider of assembly automation and high precision liquid handling solutions, Ginolis’ new representative office will offer sales and technical support to customers in the Asia Pacific region. “The opening of our first office in Asia is a great milestone for Ginolis.

Medical robotics has a future in China

A host of medical robotics outfits have emerged in China in recent years as companies seek to take advantage of the country’s growing need to automate medicine, GCiS China Strategic Research analyst Siao Tin Soh writes in Robohub. China’s medical robots market was up more than a third in 2016, to 791 million Chinese yuan