Medical Devices

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.

On 13.03.2019, the SAMR (State Administration for Market Regulation) released new review measures for advertisements for pharmaceuticals, medical devices, health foods, and food for special medical purpose. The draft is open to public comments.

In the article A fortunate opportunity? Navigating Chinese regulation challenges to ensure success Anna Fischer from Cisema Hong Kong sets out the key challenges that foreign manufacturers of medical devices face in obtaining approval for and access to the Chinese market. Read the article on MedTech ENGINE.

On 14.08.2018, the SAMR defined the 8th batch of Drug - Medical Device Combination Products in their announcement No. 218-2018. When applicants are unsure, whether a product is categorized as a medical device or drug, a classification application can be submitted to the SAMR for verification.

On 01.08.2018, the SDA published the interpretation for the new Medical Device catalogue, which contains some changes regarding classifications. Some Class II products have been upgraded to Class III and some Class III products shall be considered as Class II.

As mentioned in our March/April news: On 13.03.2018, during the 13th National People's Congress, China’s cabinet decided for the SAMR (State Administration for Market Regulation) to supervise the - NMPA (China Food and Drug Administration), - AQSIQ (General Administration of Quality Supervision, Inspection and Quarantine), and- SAIC (State Administration for Industry and Commerce).The “3 stipulation scheme” published in August by the State Council details the staffing, administrative structure and functions of the SAMR.

On 27.09.2018, the NMPA published two Medical Device Regulation Indices (1998-2013) (NMPA WeChat announcement Nr.37. 2018). The first Index includes 114 still valid regulatory documents, covering classifications of specific devices, regulations for non-medical devices, technical guidelines, industry standards, GMPs and post-market penalties. The second Index includes 119 regulatory documents, which are no longer valid.