In December 2022, NMPA approved 339 medical devices, including 37 Class III imported products, 25 Class II imported products, and 273 Class III domestic products. A total of 2,500 medical device products were approved by NMPA in 2022.
NMPA is encouraging China end uses for more domestic products in latest years. Thus, more and more overseas manufacturers are planning localization in China.
Below is a list of approved Class III and Class II imported products in December, 2022.
Medical Device/IVD
Manufacturer
Category
Emprint™ Ablation System with Thermosphere™ Technology
Covidien llc
Class III
Single Photon Emission Computed Tomography System
Spectrum Dynamics Medical Ltd.
Class III
Insulin Pump
SOOIL Development Co., Ltd
Class III
HIV Ag/Ab Combo (CHIV) Assay
Siemens Healthcare Diagnostics Inc.
Class III
Anesthesia System
MAQUET CRITICAL CARE AB
Class III
Phacomeulsification/Vitrectomy system and accessories
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
NMPA issued a notice on the deferment of payment of registration review fees for drugs and medical device products (No. 81 of 2022) on September 29, 2022.
The main contents are as follows:
Registration applicants who submit applications for registration of drugs and medical devices products and are accepted during the October 1 to December 31, 2022, the registration fee is suspended for one quarter from the date it is due, without late payment fees.
Payment of review fees can be made by individuals using the payment code online transfer, but it needs to be handled in the bank that has opened the “non-tax payment” item.
Recently, because of the Covid-19, the average acceptance review time will be increased by 2 working days on top of the original 5 working days.
NMPA Encouraging Enterprises to Lead Standard Drafting
According to the work deployment of the NMPA, the Center for Medical Device Standardization Administration NMPA has drafted the “Enterprise Led Drafting of Recommended Industry Standards for Medical Devices (Trial)” under the framework of the “Medical Device Standardization and Revision Management” to regulate the drafting of recommended industry standards for medical devices by enterprises. With the approval of the NMPA, the draft for comment is now available for public comment as required.
This is the description of the new and old standard system given by the National Standards Commission when the group standard came out in 2018, that is, the recommended industry standard should be dominated by the government.
NMPA Collects Public Comments On Guidelines for Registration Review of Implantable Medical Device Battery
In order to standardize the requirements for technical review and guide the registration and application of enterprises, CMDE has organized the drafting of the Guidelines for Registration Review of Implantable Medical Device Battery (Draft for Comments), which will solicit comments from now on.
Scope Of Application
These guidelines apply to implantable medical device batteries, for other medical device batteries also have some reference significance, including but not limited to lithium-ion batteries, nickel-metal hydride batteries, nickel-cadmium batteries, lead batteries, dry cells and other chemical batteries, photovoltaic batteries and other physical batteries, flexible batteries and other new batteries.
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