Medical Devices

On 4.3.2020, the China-Britain Business Council (CBBC) and Cisema held a webinar together to talk about the market, regulations and standards for overseas medical device products to enter the China market. Our business consultant, Anna King, provided an overview of the approval systems for NMPA registration in China and the recent implementation of urgent measures to expedite the approval procedures for medical and health products due to the CoronaVirus outbreak.Watch the recording of the webinar on Youtube.

On 20.12.2019, the China NMPA (National Medical Products Administration) announced (No.91-2019) that it would add 148 medical devices and 23 in-vitro diagnostic reagents to the clinical trial exemption list, as well as to revise the names and descriptions of 48 medical devices and 4 in-vitro diagnostic reagents. Medical devices and in-vitro diagnostic reagents on the clinical trial exemption list won’t require completion of clinical trials in order to achieve NMPA certification.This new clinical trial exemption list is effective since the date of announcement on 20th December.Feel free to contact us if you would like to know what products were included in the clinical trial exemption list for medical devices, and the clinical trial exemption list for IVDs.

From October 25^th to November 1^st, China SAMR publicly solicited opinions upon its release of the third draft on the measures of advertising review management for health food, FSMP, drug products and medical devices.SAMR had been open to public feedback from March 13^th to April 13^th and June 6^th to June 26^th followed by adjustments made to the first and second draft.As revealed in the previous announcement and drafts, SAMR aims to formulate a major regulatory reference in future by requiring compliance for advertising health food, FSMP, drug products and medical devices including, but not limited to, the following conditions:Content (e.g. name, application scope, composition):

• Must match the details in NMPA registration documents, certificate and IFU
• Must be legal and truthful
• Must not mislead or deceive users

Disclaimers necessary:

• Personal use devices:g. ‘Please read the instructions before using the device’ or ‘Please seek the advice of a healthcare professional when buying and using this device’
• If safety instructions & precautions are mentioned in NMPA certificate, they must be displayed clearly in the advertisement

e.g. ‘Please read carefully the precautions before using the device’Approval number of the advertisement:

• Must be clearly indicated in the advertisement

For further information on the above topic, please contact us.

In accordance with the NMPA (National Medical Products Administration) publication No. 66-2019, the UDI (Unique Identification System) will be mandatory for medical devices in China as of 01.10.2019.There are currently the following two relevant guidelines:• Rules for the Unique Identification System of Medical Devices• YY / T 1630-2018 Fundamental Requirements for UDI The UDI code application has to be submitted to ANCC (Article Numbering Center of China). Starting 01.10.2019, the registered UDI code has to be provided to the NMPA as part of initial registration, renewal or change applications. Prior to exporting to China, all newly registered products must be labeled with the UDI code.