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China Allows Laboratory Developed Test (LDT) Now with Order 739


IVD CDx questions about China Medical Devices

The new “Regulation for Medical Device Administration and Supervision”, Order 739 LDT was released on Mar 18, 2021. The effective date is June 1, 2021. It will replace Order 680. Order 739 is a long-awaited overarching policy regulating NMPA medical device and IVD, covering 8 chapters and 107 articles for the complete product life cycle. Article 53 allows the development of laboratory developed tests (LDT) in China.

Article 53 states that if there is no product of the same type that has China market approval, the eligible medical institutions can develop their own in vitro diagnostic reagents (IVD) based on the clinical needs of the institutions.  Such in-house developed IVD reagents can be used in the institutions under the guidance of a licensed physician.”This new regulation relaxes the restrictions on LDTs in China—allowing China medical institutions to develop their own IVD reagents under certain conditions:

  1. It is only applicable for IVD reagents which have no NMPA approved predicates.
  2. Medical institutions need to meet certain requirements.
  3. The LDT is to meet the clinical needs of the medical institutions.
  4. The LDT can only be used within the medical institution which develops it.
  5. The LDT need to be used under the guidance of a practicing physicians

Although at this stage, both the development and usage are restricted within the eligible medical institutions, the Independent Clinical Laboratories (ICL) and molecular diagnostic companies can benefit from this new regulation through collaboration with medical institutions in China. The eased restriction will certainly help to accelerate the development in new IVD products.

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