Recently, the innovative product Single Photon Emission and X-ray Computed Tomography Imaging System of Beijing Novel Medical Equipment Ltd. is approved by China NMPA. This product consists of a single photon emission computed tomography (SPECT) host (including two SPECT detectors), CT host frame, examination bed, PDU server, acquisition client workstation, SPECT acquisition server workstation, CT …
Medical device registration fees in China Medical Device Class Initial Amendment Renewal(every five years) Clinical trial application fee(High-risk medical devices) Domestic class III RMB 153600 RMB 50400 RMB 40800 RMB 43200 Imported class II RMB 210900 RMB 42000 RMB 40800 — Imported class III RMB 308800 RMB 50400 RMB 40800 RMB 43200 For more information, …
On October 23, 2023，NMPA announcement No. 135 [2023], NMPA has decided abolished YY 0569-2011 “Class II Biological Safety Cabinet” and YY/T 0687-2008 “Surgical Instruments – Non-cutting Articulated Instruments – General Technical Conditions” two medical device industry standards.
On September 5, 2023, the China State Food and Drug Administration issued an announcement on 45 medical device industry standards including YY0304-2023 “Plasma Sprayed Hydroxyapatite Coated Titanium Dental Implants” (2023 No. 118). For more information, please contact us by email info@gvmmedical.com.
This article is focus on how to deal with the renewal of existing registrations, the adoption of new and recommended standards, and the modification of product instructions and labels. 1. Renewal of Existing Registrations: If medical devices applying for registration renewal can’t meet the new mandatory standards, the renewal will not be granted. Existing registrations …
NMPA published its mandatory YY standards and recommended YY standards modification plan on May 23, 2023 (Refer to Notification 17-2023). Below are some of the standards: Cardiopulmonary diversion system：Disposable arteriovenous cannula (YY 0948-2015, ISO 18193:2021) Single-use hollow fiber blood filter ( YY 0465-2019, ISO 8637-3:2018 ) Medical Electrical Equipment Part 2-87: Specific requirements for basic …
The guidance document was released on July 26, 2023. It’s the NMPA current thinking about the clinical evaluation of the Powered Laser Surgical Instrument. This guideline applies to powered laser surgical instruments intended to reduce human hair and wrinkles, treat hyperpigmented skin diseases and skin vascular diseases, and treat scars (Product Code 09-03-01, Class III). …
Guidelines – Clinical Evaluation of the Powered Laser Surgical Instrument Read More »
In order to further deepen the reform of the medical device review and approval system, based on the actual development and supervision of the medical device industry, and in accordance with the relevant requirements of the “Regulations on the Supervision and Administration of Medical Devices” and the “Dynamic Adjustment Work Procedures for the Classification of …
Some content adjustments in the “Medical Device Classification Catalogue” Read More »
On July 24, the NMPA issued the catalog of medical devices exempt from clinical evaluation: In order to do a good job in the management of medical device registration, according to the “Measures for the Administration of Medical Device Registration and Filing” (State Administration of Market Regulation No. Circular No. 71 of 2021), which is …
Update! Medical Devices Clinical Evaluation Exemption Catalogue Read More »
First registration period for Class II medical devices Project approval stage Plan, budget, 1 month. Document preparation before acceptance Considering that the average cost of testing is 6 months, it may vary depending on the product situation. Clinical trials cannot be performed in parallel with testing, and the clinical time should be calculated separately, and …
