China Develops Special Regulatory Pathway for Local Innovative Medical Device Products

Global Life Sciences: China Update

As a part of its 12th Five-Year Plan, the Chinese government has announced a number of policies intended to encourage local research and development on medical device products in order to reduce China’s dependence on importation of high-end and high-value device products. In furtherance of these policies, China’s newly restructured food and drug regulatory agency, the China Food and Drug Administration (CFDA), is developing a special pathway for review and approval of innovative medical device products.

In a draft regulation recently published by CFDA, the agency said that it intends to create a dedicated office, a dedicated database, and a dedicated expert panel to review and approve innovative medical device products, and to offer more flexibility in the review process. This special pathway would be more interactive and expedited than that for standard devices.

This pathway, however, will only be available to local device manufacturers and locally patented products; medical devices manufactured outside of China would not be eligible. Under the CFDA draft regulation, to qualify for this special review process, the applicant must be a locally-incorporated medical device manufacturing enterprise and have completed early stage research with a robust and complete traceable database, and the products must be made in China and exhibit fundamental improvements over current devices with significant clinical value. Significantly, the products must be protected by P.R.C. invention patents that are either self-developed or licensed by the applicants.

Sidley China Life Sciences Practice

Sidley has a powerful, fully integrated life sciences practice serving multi-national pharmaceutical, biotechnology, medical device and food companies in every aspect of their business operations in China. Sidley’s Foreign Direct Investment, general Commercial, Corporate, M&A/Joint Venture, Antitrust, FCPA, Licensing, IP, provincial government work, as well our Regulatory practice permits us to serve virtually every legal need of our life sciences clients in China.

Sidley is the first international law firm to establish a stand-alone, comprehensive food and drug regulatory practice in China. As an integral part of our Global Life Sciences practice, we bring our knowledge of industry practices in the U.S. and EU to each project in China and help develop global Standard Operation Procedures (SOPs) and benchmark best practices.

For further information on the China Life Sciences Practice, please contact:

Chen Yang

Partner

+86.10.6505.5359

cyang@sidley.comZhengyu Tang

Partner

+86.21.2322.9318

zytang@sidley.comYuet Ming Tham

Partner

+852.2509.7645

yuetming.tham@sidley.com

Sidley Global Life Sciences Practice

On three continents, Sidley’s Global Life Sciences Practice team offers coordinated cross-border and national advice on Food, Drug and Medical Device Regulatory, Life Sciences Enforcement, Litigation and Compliance, Healthcare Regulatory, Products Liability, Intellectual Property, Corporate and Technology Transactions, Securities and Corporate Finance, International Trade and Arbitration, FCPA/Anti-Corruption, Antitrust/Competition, Environmental/Nanotechnology.

Globally rated as one of the top life sciences practices, our team includes former senior government officials, medical doctors and leaders in various life sciences fields.

For further information on the Global Life Sciences Practice, please contact:

Scott Bass

+1.202.736.8684

+1.212.839.5613

sbass@sidley.comJames C. Stansel

+1.202.736.8092

jstansel@sidley.com Michael W. Davis

+1.312.853.7731

mdavis@sidley.com Paul E. Kalb

+1.202.736.8050

pkalb@sidley.com M. Patricia Thayer

+1.415.772.7469

+1.650.565.7569

pthayer@sidley.com David J. Zampa

+1.312.853.4573

dzampa@sidley.com

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This Sidley Update has been prepared by Sidley Austin LLP for informational purposes only and does not constitute legal advice. This information is not intended to create, and receipt of it does not constitute, a lawyer-client relationship. Readers should not act upon this without seeking advice from professional advisers.

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