The revised Regulation for Supervision and Administration of Medical devices (article 53) that went into effect on June 1 enhances the abilities of some medical facilities to develop and use unregistered IVDs as Laboratory Developed Tests (LDTs) in China. This revision only applies to LTDs where there are no similar IVDs approved in China. This change should lead to increased renovation and use of LDTs. It has also led to more lab testing for human tissues for clinical trials. However, there is still some uncertainty about the new revision and there may be some pitfalls. For example, if a lab comes up with a new LDT and there is a similar IVD that is registered and there is now a shortage of the IVD, the LDT may not be available to the public. Also, only some LDTs are exempted from registration in China.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.