Medical Devices

China Food and Drug Administration (NMPA) report on registration of medical devices in China.NMPA recently published its Annual Report 2016 on medical device registration. The number of registrations in Class II, III and IVD has increased to 8.653, which is a plus of 14.9 % compared to the previous year. The retracement suffered in 2015 was due to the various regulatory changes dating back to 2014 as well as the increase of application fees in 2015, but the current figures have reached the 2014 level again.A large percentage of applications for the registration of medical devices and IVD comes from abroad. Class II had 3.095 applications from abroad, which is an increase of 2% compared to 2015 and in Class III there were 2.818 applications, an increase of even 15%.The P.R. China continues to promote the import of high-end and high-cost medical devices from abroad. The top five class II and III product groups of foreign origin to be registered in 2016 were:

1. Implanted material and artificial organs (509) – was on place 2 in 2015
2. Medical optical instruments, devices, and endoscopes (406)
3. Medical electronic instruments and devices (285)
4. Medical polymer material and products (249)
5. Devices and instruments for OR, IR, and Doctor’s consulting room (141) – superseded dental care equipment.

According to the NMPA report 2016, top of the list of registrations of foreign class II and III products (including IVD) were the USA followed by Germany, places 3, 4 and 5 were held by Japan, United Kingdom and Korea.Further information concerning this topic can be obtained from:Cisema GmbHTel.: +49 89 4161 7389–00Fax: +49 89 7484 9956info@cisema.dewww.cisema.com

Simplifications of clinical studies for medical devices and pharmaceutical products in China.On 11.05.2017 NMPA (China Food and Drug Administration) issued two announcements – no. 2017-52 and -53 – handling the simplification of clinical studies in China. Medical devices and pharmaceutical products can thus be launched in China much easier.1. Policies about promoting market approval of new and innovative drugs and medical devices:This proposal refers particularly to innovative treatment methods for life-threatening diseases. If such a product turns out to be successful at an early stage of the clinical study, it can be put on the market with reservations even before the clinical study has been finished.2. Policies about administration of clinical trials on the innovation of medical devices and drugs:This is an initiative which allows all hospitals and medical institutions to carry out clinical studies in China, which, up to now, only specially accredited hospitals of the highest category, were allowed to do. In the future, a medical institute only has to register on the NMPA website, in order to be allowed to perform clinical studies.Furthermore, the draft allows clinical studies which were performed abroad to be used for product registration in China, as long as they comply with the “Requirements of the NMPA Drugs and Medical Device Registration”. The only exception are eight Class III high risk medical devices like implantable cardiac pacemakers, blood pump, infusion pump for medicines, stents, artificial organs and orthopedic components (see NMPA Notice 2014/14 ).On 17.05.2017 the draft of the third revised list for medical devices exempted from clinical studies was issued. It contains 22 class II and 6 class III products.These measures will give Chinese patients a faster access to innovative and improved treatments and reduce the launching costs.NMPA has used much effort in the past years to make the registration process more efficient and safe. The number of employees working for registration was increased by 450 in a period between mid-2015 and end of 2016, which means a fourfold increase.In April this year the Supreme People’s Court of the People’s Republic of China announced a new interpretation of the criminal code, according to which persons who forge clinical studies are facing severe punishment. If a drug, which was registered with forged clinical studies and caused injury to a patient’s health, the forger faces a 10 years’ imprisonment – if the patient dies, even a death sentence is possible. Even if the drug in question was not registered and did not cause any harm, the submission of falsified registration documents is punished with a 3 years prison sentence. Should any organizations entrusted with the performance of clinical studies be involved in any fraud, their accreditation will be cancelled.For further information on the above topics, please contact:Cisema GmbHTel.: +49 89 4161 7389 – 00info@cisema.dewww.cisema.com

NMPA has Formulated Confidentiality Measures in Regards to Review and Approval of Drugs and Medical Devices.

In order to protect the rights and interests of the manufacturer of pharmaceuticals and medical devices, NMPA (China Food and Drug Administration) issued a code of confidentiality for all employees involved in the registration process.According to the code, all employees involved in a registration process must sign a confidentiality agreement, whose compliance is strictly monitored. Should an employee be in violation of the agreement, he will be punished. Depending on the severity of the failure, the consequence is a disciplinary punishment which can range from a written warning or dismissal up to legal action against the employee.If the applicant of the registration can prove that the information disclosed by relevant staff or expert leads to losses, he has the right to file a lawsuit.If the NMPA pays a compensation according to the judgment of people's court, they will reclaim part or all of the compensation costs from the violating employee or expert.For further information please contact:Cisema GmbHTel.: +49 89 4161 7389 00Fax: +49 89 7484 9956info@cisema.dewww.cisema.com

NMPA Released a Note about Standardizing the Classification of Medical Devices. On 10.10.2017 the NMPA (China Food and Drug Administration) introduced in its Notice No. 2017/127 a specific work flow for the classification of medical devices, which applies to newly developed medical devices that had not yet been included in the "Medical Device Catalogue". The regulation officially comes into force on 01.08.2018 but experience has shown that it will probably be applied in practice earlier than this.

On 04.11.2018, the new official website of NMPA (National Medical Products Administration) - former NMPA (China Food and Drug Administration) - was activated (https://www.cfda.gov.cn/). There are no significate changes regarding the content and functions of the website.

On 21.11.2018, Premier of the State Council, Li Keqiang, announced the extension of Cross-Border-E-Commerce (CBEC) beyond 31.12.2018. CBEC enables companies to sell certain products (e.g. cosmetics) to customers in China on dedicated online platforms without NMPA (former NMPA) certificate. Moreover, CBEC experimental zones were extended from 15 to 37 cities, such as Beijing, Shenyang, Nanjing, Wuhan, Xi'an and Xiamen. 63 new items were added into the “CBEC retail import list”, containing those products, which are not subject to import tariffs and solely require 70% of the applicable VAT and consumption taxes. Furthermore, the single purchase limit was raised from RMB 2,000 to RMB 5,000 and the annual transaction limit was raised from RMB 20,000 to RMB 26,000 per person per year.

On 12.09.2018, the CMDE (Center for Medical Device Evaluation) announced that they will provide a pre-reviewing service for supplementary documents of medical device starting 08.10.2018 (CMDE No. 08-2018). This service will be available for domestic Class III, as well as imported Class II and III medical devices if it is the first NMPA (China Food and Drug Administration) registration in China. With this service, CMDE aims to ensure that the prepared supplementary files fulfil the requirements as they can only be submitted once after the receipt of the corrective notice.

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.

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.