4.”Guidelines for Verification of Virus Inactivation Processes for Allogeneic Implantable Medical Devices (Revised Edition in 2020)”;
5. “Guidelines for Registration and Review of 3D Printing Patient Matching Mandibular Prostheses”;
6. “Guiding Principles for Medical-Industrial Interaction Quality Control Review of Personalized Matching Bone Implants and Tools”;
7. Draft for Comments: “Technical Review Guidelines for Clinical Evaluation of Ultrasonic Soft Tissue Cutting Hemostasis System”;
8. Draft for Comments: “Guidelines for Medical Device Cybersecurity Technical Review Guidelines (Second Edition)”.
UDI Implementation Delayed
In July 2019, the NMPA began piloting their UDI system for medical device. Unfortunately, due to the COVID-19, the official implementation date of the first batch of products has been adjusted from October 1, 2020 to January 1, 2021. Concurrently, NMPA added 5 more products to the first batch of the products subject to UDI implementation. The 5 newly added products are 1) ear prostheses, 2) spinal interbody fixation/replacement systems, 3) absorbable surgical hemostatic materials, 4) penile prostheses, 5) implantable drug infusion devices.
NMPA Published the Summary of the Second Batch of Product Classification Results of 2020
Products with unclear classifications will need to consult with the NMPA prior to submitting their applications. Each year, the NMPA will publish the results of these consultations and recently released the second batch for 2020 (first was published on March 30th).
In this round, there were 321 medical device classification results, 60 products were classified as Class III medical devices, 94 products were classified as Class II, and 49 products were classified as Class I medical devices. The rest were considered combo products, special situations, weren’t standalone medical devices, or not a medical device.
NMPA Issued 34 Medical Device Industrial Standards
On September 27, 2020, NMPA issued 34 Medical Device Industrial Standards which will be implemented after 2021, the 34 medical device industrial standards cover Surgical Implants, Medical Electrical Equipment, Disposables, Software, Imaging Equipment, In-Vitro Diagnostic Reagents etc. Please contact us if you would like a full list.
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