New China FDA Guidance May Speed Up Device Approvals

Law360, New York (June 17, 2015, 10:21 AM EDT) -- On May 19, 2015, the China Food and Drug Administration unveiled the Technical Guideline Governing Medical Device Clinical Evaluation. The long-awaited guideline explains the methodology and principles for clinical evaluation regarding (i) devices exempted from clinical studies and (ii) devices that may be eligible for a clinical study waiver. More importantly, the guideline clarifies that imported devices can waive in-country study under certain circumstances.

Since 2014's revisions to Regulations on the Supervision and Administration of Medical Devices[1] (also known as the Order 650) and the Medical Device Registration Rules[2] (MDRR) became effective, an applicant submitting a device license application must provide...

Stay ahead of the curve

In the legal profession, information is the key to success. You have to know what’s happening with clients, competitors, practice areas, and industries. Law360 provides the intelligence you need to remain an expert and beat the competition.

  • Access to case data within articles (numbers, filings, courts, nature of suit, and more.)
  • Access to attached documents such as briefs, petitions, complaints, decisions, motions, etc.
  • Create custom alerts for specific article and case topics and so much more!


Related Sections

Law Firms


Government Agencies

Hello! I'm Law360's automated support bot.

How can I help you today?

For example, you can type:
  • I forgot my password
  • I took a free trial but didn't get a verification email
  • How do I sign up for a newsletter?
Ask a question!