Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros in August 2022. These updates are presented by China Med Device, LLC, your partner in Chinese market access.
Eight Urgent Devices Designated in GBA: Medtronic, bioMerieux, Terumo on the List
While not-yet-approved in the mainland, Hong Kong or Macao approved drugs and medical devices can be utilized in GBA. They can be used only if the significant clinical benefits with urgent needs can be demonstrated.
Eight devices from Medtronic, bioMerieux, Terumo, etc. as the third batch were enrolled to pioneer the clinical use in GBA on July 7, 2022. Read more.
Device Master File System Has Implemented
Device master file in China is a technical document that owner of the file submits to NMPA to authorize the applicant to use in the registration but does not directly disclose the content to the applicant. The purpose of the medical device master file is to protect the technical secrets of the documents’ owner and to avoid the repeated submission of the same technical documents by different parties.
NMPA released the list of medical device manufacturers with master files submitted on August 8, 2022. Overseas manufacturers including Siemens, Takeda, Integra, Danko, Covestro are on the list. Read more.
NMPA “Common Issues” Answered in First Half of 2022
The NMPA issued Q&A for 34 common issues aroused in medical device registration over the half year. Read the list of questions.
Guidelines & Standards
Ten IVD Guidelines Issued in One Day
CMDE published ten draft guidelines for IVD reagents for feedback. They are proposed to direct manufacturers for local type testing and regulatory approval. See the complete list.
Two Imported Devices Obtain NMPA Innovation Approval in August
The NMPA granted Innovation Approvals to two overseas manufacturers, Ethicon and BioFire Diagnostics, in August 2022. Along the approval notice is the list of 176 innovation approvals since the pathway established in 2014. Read more information.