The regulation of the medical device industry in China has two layers: the product regulatory system and the enterprise regulatory system. The regulations relate to the research and development of medical devices as well as their registration, manufacturing, operation, advertising, usage, monitoring, product recall and the evaluation of adverse events. Since the first amendment of the Regulations on the Supervision and Administration of Medical Devices, (basic regulations that oversee the medical device industry), rules and normative documents have now been successively promulgated. The state is currently upgrading regulations for the medical device industry by introducing reforms and improving standards systems.
The state regulates medical devices into three different types, based on their risk level. The food and drug administration at each level will take regulatory measures on the research and development, manufacture, sale and 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 and unique views on market movements, legislative developments and regulatory tendencies. The firm has a deep understanding of the industry, abundant experience accumulated over many years, a broad client base and 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 and development, registration, manufacturing, commercialization and usage. Our legal service team is composed of lawyers with abundant experience in the industry, and they come from a range of offices and specialty areas. We provide clients with a range of one-stop legal services, such as advising on laws and regulations, mergers and acquisitions, capital markets, private equity/venture capital, intellectual property, labor, compliance and dispute resolution.
We provide legal services regarding the medical device industry to multinational companies, private equity/venture capital firms, medical institutions, listed companies, large and middle-scaled enterprises, and innovative and growth companies in the following areas:
Legal services with respect to the research and development of medical devices, clinical trials, product registration, manufacturing, commercialization, product use and product recall, and the monitoring and re-assessment of adverse events;
Cooperation in the development, research, manufacturing and commercialization of medical devices;
Intellectual property protection and services for intellectual property transactions related to product development and licensing;
Private equity/venture capital, merger and acquisitions and capital markets;
Legal services for day-to-day operations, including services related to product promotion and marketing activities, product supply and distribution arrangements, compliance, labor laws, taxation laws, dispute resolution, patient disputes and risk management; and
Legal services including compliance with laws and regulations for medical devices, compliance with anti-competition laws, compliance with anti-commercial bribery laws and compliance with privacy protection and 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 and reviewed, revised and 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 and overseas closing and post-closing arrangements, and 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.
Lepu Medical’s Issuance of GDR and 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) and 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 and raised a total amount of USD 224 million.
MedBot was listed on the Main Board of the Hong Kong Stock Exchange and 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 and 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 and underwriters of the project and 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 and distribution agreement and a research and development cooperation agreement with Beijing Tinavi
JunHe was counsel to Johnson & Johnson Medical (Shanghai) and provided a full range of legal services for the drafting, negotiation and signing of agreements for the commercial and R&D cooperation project between Johnson & Johnson Medical and Beijing Tinavi. The commercial and R&D cooperation between Johnson & Johnson Medical and Beijing Tinavi will bring new technology to orthopedic surgeons and patients in the Chinese market. This was a milestone in the field of digital surgery for Johnson & Johnson's global orthopedics business unit.