Here’s the latest China NMPA regulatory and clinical affairs news roundup for medical device and IVDs pros in May 2022. These updates are presented by China Med Device, LLC, your partner in Chinese market access.
NMPA Roundup May 2022 Policies
Certain Laboratory, Dental, Sterilization Devices Exempted from Clinical Trial
The NMPA agrees that certain devices can choose clinical evaluation exemption pathway, instead of lengthy and costly clinical trial.
The NMPA issued the “Clinical Pathway Recommendations for Certain Categories of Medical Devices” on May 19, 2022. The document suggests manufacturers how to choose clinical evaluation exemption, predicate device comparison or clinical trial. 126 medical devices in the fields of laboratory, dental, sterilization, infusion, protection, and patient carrying are affected. View the list of devices exempted from clinical trial.
Communication Guideline Issued for Hainan RWD Program
National and Hainan provincial NMPA released the “Medical Device Real-world Data Application Communication Procedures”.
The document clarifies the responsibilities of parties and workflow of communication between national and Hainan NMPA and applicants, such like the pre-sub channel in U.S. Our comprehensive review on the guideline.
New Rules on China Human Genetic Resources
“Frequently Asked Questions on Human Genetic Resources Management”, and “Implementation Rules for the Regulations on the Management of Human Genetic Resources (Draft)” were released.
The two documents involve international research & clinical trial approval, information provision or open use filing, data backup, supervision, and penalties of human genetic resources. They also list the circumstances that no longer need HGRAC approval and the requirements on ethical and security review. See more information.
NMPA Re-Classified Certain Analytical, Ortho, Dental Devices
The NMPA reclassified 27 medical devices and modified intended use for some devices.
The biochemical analysis instrument, biochemical immunoassay instrument, nucleic acid amplification analysis instrument, Orthopedic powered surgery equipment, tooth bleaching material, injectable fillers for plastic surgery and ophthalmic laser diagnostic equipment are on the list. Check out more information.
NMPA Roundup May 2022 Fast-Track Approvals
Medtronic and Three Others Obtained NMPA Innovation Approval
The NMPA granted Innovation Approvals to Medtronic and three others in May 2022. The approved devices include transcatheter implantable leadless pacing system, disposable intravascular imaging catheter, thoracic aortic stent system, etc.
The NMPA also issued the list of 160 innovation approvals since the pathway established in 2014. View more information here.
About China Med Device, LLC
China Med Device, LLC (www.ChinaMedDevice.com) provides regulatory and commercialization turnkey solutions for medical device, IVD, CDx and combination products in China. As a qualified NMPA legal agent with offices in Boston, Beijing and Hainan, we can represent manufacturers for the complete product life cycle without their need to create a local entity in China. Our regulatory services include strategy, registration, type testing, product technical requirement (PTR), clinical evaluation report (CER), clinical trial, GMP and post-market surveillance. Our commercialization services include market research, reimbursement, partnership strategy and distribution qualification.