Falls Church, VA (PRWEB) August 28, 2017
China is the future for devicemakers. It'sa wide-open market of 1.4 billion souls with a red-hot economy growing at nearly 6.7% a year.
It behooves manufacturers to play by the rules. China’s rules.
And they are changing fast. In recent months, China’s FDA (CFDA) has taken the following actions:
- Proposed a new medical device classification catalogue
- Set forth priority and expedited pathways for devices to serve unmet clinical needs
- Issued regulations on device clinical trials, procedures and positive lists for applying for exemptions from the in-country clinical trial requirement
- Made moves affecting post-marketing surveillance, including new recall regulations and proposals for new adverse event regulations
- And much more.
It’s time to see a lawyer. Specifically, a China specialist who spends every day working with Chinese device regulation on behalf of clients.
Mark the calendar for Wednesday, Sept. 13, and a webinar with lawyer, John Balzano Esq. of Covington & Burling’s New York office.
Over 90 information-packed minutes, Mr. Balzano will spell out the opportunities and guide manufucturers through China’s regulatory maze, including changes to GMPs, self-inspections, foreign inspections, and enforcement actions and campaigns.
Meet the Presenter:
John Balzano is special counsel in the New York office of Covington and Burling LLP, representing clients in the drug, biologics, device (including in vitro diagnostics), cosmetic and food spaces. He specializes in compliance with China Food and Drug Administration (CFDA) and the National Health and Family Planning Commission (NHFPC) regulation, and advises clients on developing strategies to bring products to market in China.
Who Will Benefit:
- Executive management
- Strategic planning and business development
- Engineering/design controls
- Manufacturing directors and supervisors
- Compliance officers
- Regulatory affairs
- Risk management specialists
- Personnel new to the industry
- Legal counsel
- Consultants/service providers
China’s Medical Device Regulations:
Keys to Selling More in a Hot Market
**An FDAnews Webinar**
Sept. 13, 2017 — 1:30 p.m. – 3:00 p.m. ET
$287 per site
Easy Ways to Register:
By phone: 888-838-5578 or 703-538-7600
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.