Officials From China’s sFDA Learn About Regulation of Medical Devices at Yale School of Public Health

Building on the success of last year’s program with the China State Food and Drug Administration (sFDA), a second sFDA delegation visited the Yale School of Public Health (YSPH) April 2-6 for training in the regulation of medical devices.

Robert Makuch, professor of epidemiology and public health (biostatistics), led efforts to initiate this new education program. In May, he will welcome back last year’s delegation for a second session of training in food and drug regulation.

The delegates, who are being trained as future leaders of the sFDA, included directors and associate directors of province sFDA offices and senior members from the central Beijing sFDA.

“We’d like to extend a heartfelt welcome to you all,” said Paul Cleary, Yale’s dean of public health, through an electronic translator. “Our mission is to improve health throughout the world. We have a strong relationship with China, and we’re thinking deeply about policy and regulation as a key component of protecting and promoting health all over the world. We are grateful for your visit and hope you will learn from us — though, in truth, we’re probably learning more from you.”

The training program took place in Yale’s Laboratory of Epidemiology and Public Health, with senior members of the U.S. FDA participating for a full day — including Lillian Gill, senior associate director of the Center for Devices and Radiological Health (CDRH); Christy Foreman, deputy director of the Office of Device Evaluation; Bill MacFarland, chief of the cardiac rhythm and electrophysiology branch; and Lily Ng, executive project manager of CDRH.

“This high-level U.S. delegation saw this as an opportunity to reach out to their regulatory colleagues in China,” says Makuch.

A formal delegation dinner was attended by Brian Leaderer, associate dean of YSPH.

As part of this ongoing relationship with China’s sFDA, Makuch was recently invited to give the keynote lecture to last year’s Yale delegation and other senior sFDA officials in Haikou, in China’s Hainan Province.

— By Melissa Pheterson, Yale School of Public Health

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