Medical Devices

From 01.01.2020, every products must have a Marketing Authorization Holder (MAH), which is responsible for the entire supply chain, including the production and distribution of the product.This information is misleading. In China, the MAH is the manufacturer himself. The foreign manufacturer/MAH must authorize a legal representative in China as his NMPA Legal Agent.

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.

On 01.08.2019, the CMDE (Center for Medical Device Evaluation), published a revised “Clinical Trial Exemption List for Medical Devices”. 101 Class II and 41 Class III medical devices were added. The new clinical trial exemption list contains a total of 996 medical devices now. With regards to IVDs, 420 of class II and III IVDs are exempted.

On 03.07.2019, the NMPA initiated the Pilot Work Plan for the “Unique Device Identification” (UDI) (No.56-2019), as announced in February 2018. The UDI mark, is made up of a combination of numbers and barcodes. It carries information about the product (i.e. identifying the license holder, the model specification and packaging) and its production (i.e. production batch number, production date, expiration date). The NMPA will approach applicants, which have to provide UDI applying for approval. During the pilot phase, it will be for high-risk medical devices only (such as heart, craniocerebral implants and prostheses).

On 31.05.2019 and 06.06.2019, the NMPA (National Medical Products Administration) and CMDE (Center for Medical Devic Evaluation) released three announcements regarding the eRPS (NMPA No. 46-2019; CMDE No. 4-2019; CMDE No. 5-2019). The eRPSystem serves the electronic management of medical device registrations. Starting on 01.11.2019, all documents for class II and III registration, change and renewal applications shall be submitted through this system. No hard copy documents will be accepted – except for class I medical devices. In order to log into the eRPS, a CA (Certificate Authority) has to be applied for. Once a CA is received, the applicant is only allowed to use the eRPS for further applications.

On 12.07.2019, the NMPA released a draft for the examination requirements of medical device applications (No. 42-2019). The CMDE of the NMPA is now additionally involved in the approval process by reviewing the application dossier, judging its integrity, compliance and consistency in accordance with the latest requirements.

On 14.05.2019, the NMPA (National Medical Products Administration) updated technical review guidelines on the timeline of active medical devices (No. 23-2019). As part of the medical device registration, applicants have to verify their products’ lifespan. The lifespan describes the period in which the safe use of the product is ensured, the product can be used effectively, and residual risks are still within acceptable limits.

On 07.05.2019, the CMDE (Center for Medical Devic Evaluation), announced the introduction of NMPA’s new eRPS System (Electronic Regulated Product Submission System - https://erps.cmde.org.cn). The system is used for the electronic management of medical device registrations. In future, all documents for NMPA registrations shall be submitted to through this eRPS System. No hard copy documents will be necessary.Since 10.05.2019, it is possible to apply for a CA (Certificate Authority) certificate via the eRPS System. The CA certificate is necessary to be able to log into the electronic submission system. Every registration applicant of domestic medical devices class III has to apply for a CA certificate. Equally, every NMPA Legal Agent of an imported medical device has to apply for a CA certificate on behalf of the NMPA registration applicant, the foreign manufacturer.

On 28.03.2019, the MOA (Ministry of Agriculture), published a notice regarding two administrative licensing items, which were abolished on 27.02.2019. First, the clinical trial approval of new veterinary drugs was changed to filing system. After completion of the laboratory study of the veterinary drug, the clinical trial can be carried out, without waiting for the approval of the authority. Second, the MOFCOM (Ministry of Commerce) no longer issues import licenses for veterinary biological products. It is no longer necessary for the Chinese import agent to provide such a copy when applying for customs clearance.

On 01.04.2019, the NMPA (National Medical Products Administration - former NMPA) announced a change in the clinical trial approval process for medical devices (NMPA No. 2019-26). If the applicant has not received any feedback within 60 working days from the date of clinical trial approval application, clinical trials can be carried out. Instead of an approval notification, the NMPA’s website will display the approval number, the applicant's name and address, as well as the name, the model specification, structure and composition of the medical device.