Regulatory News from Across Asia-Pacific
the emergency channel relating to COVID-19 response is no longer open due to the virus situation in China coming under control.
The State Administration of Market Regulation announced that from 01.06.2020 the certification obligation will be introduced in China.
The GB standard about “Strength requirement and test of automobile seats, their anchorages and any head restraints” will be implemented on 01.07.2020.
The China Quality Certification Center (CQC) published further support measures to contain the Covid-19 pandemic. It is also a step to improve efficiency.
The NMPA approved the US firm Allergan’s glaucoma drainage tube, the first imported medical device with the support of real-world data to register in China.
Advantage Austria together with Ms. Anna King from CISEMA inform about the recent regulatory and institutional developments in China.
A recent important change regarding the DMF registration of APIs in China with a new online application system was implemented and a new registration form.
The NMPA (National Medical Products Administration) announced the 2020 project plan and selection process for 86 medical device industry standards.
On 18.03.2020, the NMPA (National Medical Products Administration) issued the 2019 Annual Report for Medical Device Registration.In 2019, the NMPA received a total of 9,104 applications for the initial registration, registration renewals and changes in licensing items of Class III (Domestic and Overseas) and Class II (Overseas) medical devices, an increase of 37.8% from 2018. Amongst the 9,104 applications, the NMPA approved a total of 8,471 applications with an increase of 53.2% as compared to 2018. Also, the NMPA handled a total of 1,383 filing applications of imported Class I medical devices, a decrease of 20.7% as compared to 2018.
Table 1. NMPA - No. of Applications and Approvals for Medical Devices and IVDs
Chart 1. NMPA – No. of Applications and Approvals for Medical Devices and IVDs
Chart 2. Percentage Distribution of Three Types of NMPA Approvals
Chart 3. Percentage Distribution of Approvals for Medical Devices and IVDs
Chart 4. NMPA – No. of New Registrations Approved from January 2013 to December 2019
Chart 5. NMPA – No. of New Registrations Approved from January 2019 to December 2019
In 2019, the NMPA approved 1,726 new registrations in total.The provincial medical product administration (MPAs) authorities approved a total of 17,017 applications of China domestic Class II medical devices, an increase of 53.4% from 2018.The municipal medical product administration (MPAs) authorities handled a total of 16,754 filing applications of China domestic Class I medical devices, decreased by 2.4% as compared to 2018.China continues to focus on the supply of high-end, high-cost medical devices from abroad. The top five class II and III product groups of foreign origin to be registered in 2019 were:1. Medical Imaging Equipment (81 Registrations)2. Dental Instruments (57 Registrations)3. Passive Implants Devices (50 Registrations)4. Clinical Examination Instruments (41 Registrations)5. Neurological and Cardiovascular Surgical Instruments (33 Registrations)
Chart 6. 2019 Top 5 Product Groups - Registration of Overseas Class II and III Medical Devices
The United States of America, Germany, Japan, Korea and Switzerland have the highest number of initial registrations for overseas medical devices, taking up to 75.4% of the total number of initial registrations for overseas medical devices.
Chart 7. 2019 Top 5 Countries - Exporting Medical Devices to China
Special Review Procedures for Innovative Medical DevicesNMPA received a total of 179 applications for special review and approval of innovative medical devices, including 31 applications for priority review. A total of 19 innovative medical devices were approved:Imported1) Micra Transcatheter Leadless Pacemaker systemDomestic2) PET/CT imaging system3) Nucleic acid amplification detection analyzer4) Decellularized corneal implant5) Left atrial appendage occluder system6) Abdominal aorta stent-graft and delivery system7) Bioabsorbable coronary rapamycin-eluting stent system8) Porous tantalum bone filling material9) Patient monitor10) Left atrial appendage closure system11) Intensity-modulated radiotherapy planning system software12) Digital Mammography System13) Transcatheter aortic valve system14) Single-use intravascular imaging catheter15) Non-Invasive Blood Glucose Meter16) Implantable left ventricular assist system17) Coronary angiographic blood flow reserve fraction measurement system18) Disposable invasive pressure sensor19) Positron emission and X-ray computed tomography scanning systemFurther information concerning this topic can be obtained from:Cisema (Hong Kong) LimitedTel.: +852 3462 2483info@andrewb655.sg-host.comwww.cisema.com/en
According to the Guide, the registrant of the medical device is responsible for implementing a suitable QMS for the product realization process.
The NMPA announced new administrative measures designed to increase the post-market surveillance applicable to all registered medical devices sold in China.
The principles describe the manufacturing requirements to ensure the medical device operates safely and performs as intended。
AUSSENWIRTSCHAFT AUSTRIA and Cisema cohost the webinar to talk about the regulatory changes for both medical device and cosmetic industries.
Medical devices approved by the NMPA or the Ministry of Food and Drug Safety of Korea can apply for the MDACS listing in Hong Kong within a trial period
The prevention and control work were deployed as the top priority, and the registration process of some overseas medical products was expedited.
NMPA provides a regulatory pathway for CMDs to meet the special clinical demands for medical institutions in China to treat designated patients.
Cisema will submit a proposal to the NMPA about the draft regulation before the consultation period ends on 31.03.2020. If you are interested to contribute, please provide your input to us
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.
New product certification regulation from organization CCAP for automobile lighting, external plastic parts and break disks
The Israel Export Institute co-hosted a webinar together with Cisema to introduce the China administration bodies, regulations and standards for cosmetics.
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