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Compliance In Focus
Posted by John Lehmann on Fri, Apr 26, 2013

China’s Proposed Regulations on Medical Devices - What Should American Device Companies Know?

March proved to be a busy month for China and the government bodies responsible for regulatingChina%27s Proposed Regulations on Medical Devices food and drug safety.

  • • March 3, 2013: Wall Street Journal article announces China’s plan to create a FDA-like body, combining up to 13 different government agencies that regulate food and drug safety.
  • March 19-21, 2013: China joins the International Medical Device Regulators Forum  (IMDRF), a voluntary group of medical device regulators that aims to accelerate international medical device regulatory harmonization and convergence while coming together to continue the work of the Global Harmonization Task Force (GHTF).
  • March 20, 2013: China Food and Drug Administration releases two proposed medical device regulations for public comment.
  • March 27, 2013: Emergo Group publishes that China’s State Food and Drug Administration (SFDA) renames itself China Food and Drug Administration (CFDA).

Of importance to those medical device companies that do business in China, is the release of two proposed medical device regulations for public comment; Special Review and Approval Process for  Innovative Medical Devices (Interim) (draft) and  Regulation for Simplification of Application Materials Required for Medical Device License Re-registration (Interim) (draft).

Special Review and Approval Process for Innovative Medical Devices

The three differences in this process from the traditional review and approval process are:

  1. Process is managed by a special office within the CFDA
  2. Priority of review given at every stage by every office
  3. Prompt communication and guidance is provided during the process

To increase the innovation of medical device to China’s healthcare consumers, an applicant must meet the following criteria:

  • Clearly owns the intellectual property
  • Function or mechanism must be first of its kind in China and offer a fundamental improvement in safety and performance of similar devices
  • Be complete in the early stages of R & D and have a basic prototype
  • Be a legal entity in China

 This proposal aims to lessen the burden of medical device license re-registration process, by requiring fewer application documents if not changes have occurred to:

  • Model specification
  • Manufacture site address
  • Product standards
  • Functional structure/components
  • Indications for use

Applicants will no longer be required to submit operation manual, product standards or test reports for re-registration.

Do the proposed regulations help or hurt American medical device companies doing business in China? Please provide feedback and other comments regarding China’s FDA below.

Photo Credit: Dainis Matison

Understanding IRBs

Topics: Medical Devices, China, Regulatory


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