Our monthly NMPA News Roundup covers government announcements, policies, standards, guidelines, QA/recall/AE, and new approvals in medical devices and IVD in China, for the month of June 2021.
Policies
Self-Test Report to be Applicable for Class II and III Devices
The NMPA issued the “Regulations on Self-test of Medical Device Registration (Draft)” on June 2, directing manufacturers on how to self-test and to submit the testing report.
Decree 739 Regulation on Supervision and Management of Medical Devices, announced on March 18, 2021, allows self-test report to replace the report submitted by authorized testing centers. In the Decree 680 issued in 2017, only Class I device can utilize self-test report.
For the outsourcing requirements and the application materials requirements, please click HERE
Guangdong Details Urgent Clinical Use Policy for Greater Bay Area
The Guangdong government published the “Interim Provisions on the Administration of Imported Medicines and Medical Devices in Urgent Clinical Needs in the Guangdong-Hong Kong-Macao Greater Bay Area (draft)” on June 21, proposing a series of first-of-its-kind measures in China for NMPA unapproved devices. Feedback needs to be submitted by July 5, 2021.
Hong Kong or Macao approved, but not-yet-approved in the mainland, drugs and medical devices can be utilized in nine cities in Guangdong province, according to policy dated back to November 25, 2020.
For the scenarios to utilize the unapproved devices in Guangdong and the requirements for hospitals, please click HERE.
NMPA Guideline Proposes All Class III Devices Subject to UDI
Unique Device Identification (UDI) will be implemented on all Class III devices, announced by NMPA at the “Notice on Applying Unique Device Identification System for the Second Group of Devices (draft for feedback)”. The proposed effective date is January 1, 2022.
69 high-risk class III device were included in the UDI application of First Group of Devices, which started from January 1, 2021. Now all the rest of Class III devices will follow suit. Click HERE for more information
NMPA Official Opinions on Class II Active Medical Device Modification Registration
Decree 739 mandates that “if the design, raw materials, production process, scope of application, method of use, etc. of registered Class II and Class III medical devices undergo substantial changes, which may affect the safety and effectiveness of the medical device, the registrant shall apply the registration modification to the original registration department”.
NMPA officials provide the common issues occurred in Class II active device modification process to enable manufacturers better understand the requirements. Click HERE for the full Q&A
Guidelines
Passive Implantable Shelf-life Guideline Pays More Attention on Batch-to-Batch Variability
The NMPA issued the “Guideline of Shelf-life for Passive Implantable Medical Device”. It is the revised version of “Guideline of Shelf-life for Passive Implantable Medical Device” issued in May 2017. Compared with last one, this edition pays more attention on batch-to-batch variability. For the outline of the guideline please click HERE
Fast-Track Approvals
Three Cardio Device Manufacturers Proceed to Innovation Pathway
The CMDE granted four innovative review statuses on June 22, 2021, three of which are cardiovascular-related. Click HERE for the full list
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.
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