Zimmer Holdings, Inc. will soon be training regulators at their facility, “sharing knowledge and expertise in research, development, quality and regulation related to musculoskeletal health.”
According to a November 15, statement from the company, the purpose is to “allow regulators to gain industry knowledge and to understand Zimmer and its products through dialogues and trainings undertaken by its State Inspectors.”
Ok, the regulators are not the FDA and the facility is not in Warsaw, Indiana. The regulators are the Chinese BJDA (Beijing Drug Administration) and the facility is at Montagne, Zimmer’s wholly-owned Chinese subsidiary. In the U.S. such collaboration might be considered a little too cozy between the regulators and the regulated. However, it would be a mistake to think the Chinese don’t take regulation seriously. A previous chief regulator was executed for corruption.
Under terms of a Memorandum of Agreement, which is a first with the Chinese government for Zimmer, BJDA will provide the company with professional training regarding Chinese laws and regulations related to the manufacture and sale of medical devices. Zimmer, in turn, will share experience in areas including research, development, inspection, clinical use and quality systems management. The company already provides professional education training to surgeons through the Zimmer Institute.
Dvorak: “Strengthening Commitment”
“This collaboration with the Beijing Drug Administration marks a new milestone for Zimmer in China. Worldwide, Zimmer is a recognized leader in the development of products, services and professional training that helps patients overcome pain and regain mobility, ” said David Dvorak, president and CEO of Zimmer. “Cooperating with BJDA, we are strengthening our commitment to the Chinese market. The knowledge and expertise Zimmer’s employees and the state regulators will share with one another will help to elevate orthopedic medicine in China.”
Lu: “Achieving 12th Five-Year Plan Goals”
Lu Aili, deputy director general of Beijing Drug Administration, said, “The trainings provide a platform by which both sides will be able to gain from each other’s strengths related to medical devices, especially in the area of orthopedic reconstructive. Overall, BJDA is committed to working with all our partners and industry stakeholders to achieve the goals set forth in the 12th Five-Year Plan of upgrading the healthcare industry and ensuring citizens’ health and quality of life.”
China, according to the company, is among the fast-growing emerging markets for medical devices, with high unmet needs in the treatment of musculoskeletal diseases, including arthritis. Primarily associated with the elderly, arthritis is on the rise as China’s population ages. According to recently released statistics by the China National Committee on Aging, the number of Chinese senior citizens is expected to increase from the current 185 million to 487 million, or 35% of the population, by 2053.
Zimmer, with more than 9, 000 employees, has operations in more than 25 countries and sells products in more than 100 countries. The company’s 2011 sales were approximately $4.5 billion.
