Medical Devices
The regulation of the medical device industry in China has two layers: the product regulatory system m88 casino the enterprise regulatory system. The regulations relate to the research m88 casino development of medical devices as well as their registration, manufacturing, operation, advertising, usage, monitoring, product recall m88 casino the evaluation of adverse events. Since the first amendment of the Regulations on the Supervision m88 casino Administration of Medical Devices, (basic regulations that oversee the medical device industry), rules m88 casino normative documents have now been successively promulgated. The state is currently upgrading regulations for the medical device industry by introducing reforms m88 casino improving stm88 casinoards systems.
The state regulates medical devices into three different types, based on their risk level. The food m88 casino drug administration at each level will take regulatory measures on the research m88 casino development, manufacture, sale m88 casino application of medical devices, depending on their category.
With many years of legal experience in the medical device industry, JunHe is equipped with sensitive insight m88 casino unique views on market movements, legislative developments m88 casino regulatory tendencies. The firm has a deep understm88 casinoing of the industry, abundant experience accumulated over many years, a broad client base m88 casino a good working relationship with the regulatory authorities. We provide clients with a full range of legal services covering the entire life cycle of medical devices including research m88 casino development, registration, manufacturing, commercialization m88 casino usage. Our legal service team is composed of lawyers with abundant experience in the industry, m88 casino they come from a range of offices m88 casino specialty areas. We provide clients with a range of one-stop legal services, such as advising on laws m88 casino regulations, mergers m88 casino acquisitions, capital markets, private equity/venture capital, intellectual property, labor, compliance m88 casino dispute resolution.
We provide legal services regarding the medical device industry to multinational companies, private equity/venture capital firms, medical institutions, listed companies, large m88 casino middle-scaled enterprises, m88 casino innovative m88 casino growth companies in the following areas:
Legal services with respect to the research m88 casino development of medical devices, clinical trials, product registration, manufacturing, commercialization, product use m88 casino product recall, m88 casino the monitoring m88 casino re-assessment of adverse events;
Cooperation in the development, research, manufacturing m88 casino commercialization of medical devices;
Intellectual property protection m88 casino services for intellectual property transactions related to product development m88 casino licensing;
Private equity/venture capital, merger m88 casino acquisitions m88 casino capital markets;
Legal services for day-to-day operations, including services related to product promotion m88 casino marketing activities, product supply m88 casino distribution arrangements, compliance, labor laws, taxation laws, dispute resolution, patient disputes m88 casino risk management; m88 casino
Legal services including compliance with laws m88 casino regulations for medical devices, compliance with anti-competition laws, compliance with anti-commercial bribery laws m88 casino compliance with privacy protection m88 casino data security.
Recent Representative Cases
SSI Diagnostica A/S Acquisition of BGB’s Vitro Diagnostic Reagent Business
As the PRC legal advisor to SSI, we conducted legal due diligence on BGB, participated in the design of the transaction structure m88 casino reviewed, revised m88 casino negotiated the full set of transaction documents. JunHe’s team provided legal advice on major issues of concern to the acquirer, assisted the client to complete the signing of the full set of transaction documents, simultaneous domestic m88 casino overseas closing m88 casino post-closing arrangements, m88 casino provided professional legal advice on various government approvals/recordings. JunHe also provided advice on the settlement of the registered capital for the payment of the equity transfer price.
Integra’s acquisition of the assets of Johnson & Johnson
While preparing the transaction documents for the Chinese party, JunHe’s deal team worked closely with Johnson & Johnson’s global team to balance the global terms m88 casino conditions with the local regulations m88 casino practice in China. JunHe has abundant experience in the healthcare industry m88 casino assisted the client in reviewing m88 casino finalizing the transitional service agreement. The transfer of the employment relations was a challenge in this transaction m88 casino JunHe provided practical m88 casino effective suggestions on how Johnson & Johnson could control its legal risks under Chinese labor laws.
Lepu Medical’s Issuance of GDR m88 casino listing on the Swiss Exchange
JunHe as the domestic legal counsel to the underwriter participated in the entire process of the issuance of global depository receipts (GDR) m88 casino listing on the Swiss Exchange by Lepu Medical on September 21, 2022. Lepu is the first A-share listed company in the pharmaceutical manufacturing industry to issue GDR m88 casino raised a total amount of USD 224 million.
MedBot was listed on the Main Board of the Hong Kong Stock Exchange m88 casino became the first surgical robot stock in the Hong Kong capital market
JunHe was the PRC legal advisor to the joint sponsor of the project m88 casino was involved in the listing of MedBot on the Main Board of the Hong Kong Stock Exchange on November 2, 2021, which raised approximately HK$ 1457 million.
China's first early cancer screening stock: New Horizon Health’s listing on the Hong Kong Stock Exchange
JunHe was the PRC legal advisor to the joint sponsors m88 casino underwriters of the project m88 casino was involved in the listing of New Horizon Health Limited ("New Horizon Health") on the Main Board of the Hong Kong Stock Exchange on 18 February 2021, which raised over HK$ 2 billion.
Johnson & Johnson Medical (Shanghai) signed a joint marketing, promotion m88 casino distribution agreement m88 casino a research m88 casino development cooperation agreement with Beijing Tinavi
JunHe was counsel to Johnson & Johnson Medical (Shanghai) m88 casino provided a full range of legal services for the drafting, negotiation m88 casino signing of agreements for the commercial m88 casino R&D cooperation project between Johnson & Johnson Medical m88 casino Beijing Tinavi. The commercial m88 casino R&D cooperation between Johnson & Johnson Medical m88 casino Beijing Tinavi will bring new technology to orthopedic surgeons m88 casino patients in the Chinese market. This was a milestone in the field of digital surgery for Johnson & Johnson's global orthopedics business unit
