Andy Wang

Practice Areas

Andy is a partner of Dentons Shanghai office who specializes in mergers & acquisitions, licensing projects, anti-bribery, data protection, anti-trust, advertisement, and regulatory requirements with a focus on the industries of life sciences and healthcare.

Career

2012 to date: Dentons Shanghai, partner

Sep 2011– June 2012: seconded counsel at Siemens

2007 – 2011: Pinsent Masons LLP, associate

2005 – 2007: Ingersoll Rand, regional counsel for China

2000 – 2005: Allen & John Law Firm, lawyer

Professional Memberships

Member of Shanghai Lawyers Association

Publications

• A series of articles on the topic of new medical device regulations in China (2021)

• “The Legal Pathway for Drug Marketing Authorization Transfer under MAH System”(2021)

• “Inspection Manual for the Update of Clinical Trial Agreement” (2020)

• “Compliance Control of Indirect Third Parties in Pharma and Medical Device Industries”(2020)

• “How to Get Medical Product Quickly Approved for COVID-19 in China?” (2020)

• “A brief Introduction to Compliance Management of RUO Products in China” (2019)

• “Observations on Highlights of China’s New Rule on Human Genetic Resources” (2019)

• “Health Data Protection in China – Part I and II” (2018)

• “2017 Year in Review - Penalty Counting for Pharmaceutical Industry in Shanghai”(2018)

• “China’s New Round of Reform of Accelerating Regulatory Approval on Medical Products” (2017)

• “Kill the Black Swans - Probably a Revolutionary Change in the Antibribery Regime in China” (2017)

• “Revenue-Based Commission - a Risk for CSO” (2017)

• “Summary of Local Policies to Implement Two-invoice System in Healthcare Industry and Our Observation” & “National Version of Two-invoice System” (2017)

• “2016 Year in Review – Penalty Counting for Medical Institutions in Shanghai” (2017)

• “Penalty Counting for Pharmaceutical, Medical Device Companies and Drug Stores in Shanghai” (2017)

• “New Features Introduced by New Medical Device Recall Measures” (2017)

• “Latest Changes in China’s Administration on Internet-based Pharmaceutical Trading” (2017)

• “In-Progress Reform of China’s Approval Regime on Medical Products” (2017)

• “China’s 3-Year-Old Medial Device Regulations Changed” (2017)

• “Where is the Safe Harbour?-Preliminary Analysis of Loyalty Discounts in the Tetra Pak’s Penalty Case” published on CCH in 2016

• “What China Should Learn from GDPR on Protection of Health Data” published on CCH in 2016

• “How Foreign Investors Invest in the Chinese Genetic Diagnosis and Therapy Industries” published on CCH in 2016

• “What Healthcare Players Could Learn from the Anti-Trust Guideline for Automobile Industry (Draft for Comments)” published on CCH in 2016

• “How China Protects Personal Data Concerning Health” published on CCH in 2016

• “How Non-Hong Kong, Macao or Taiwan Foreign Investors Set Up a Medical Institution in the Form of WFOE in China” published on CCH in 2016

• “Red-Letter VAT Invoice A Safe Harbor for Sales Rebates” published on CCH in 2016

• "AppleWatch, Medical Device?" published on CCH and LexisNexis in April 2015

• "The Implications to the Life Science Sectors of 2015 Edition Foreign Investment Industries Catalog" publised on CCH and LexisNexis in March 2015

• "The Three Misreading on China's Regulatory Requirement on Gene Testing Business" published on LexiNexis in Jan 2015

• "What Can We Benefit from the New Medical Device Regulations" (bilingual) published on LegalSutdio in April 2014

Work Highlights

Andy focuses on life science and pharmaceutical industries and advises a number of medical device, pharmaceutical and life science enterprises on their daily operation, contract management for major projects, mergers & acquisitions, competition, anti-bribery, regulatory requirements and dispute resolution etc. As one of his work highlights, he advised on the first proton and heavy ion system project in China, including contract management, radiation issue, clinical trial and registration, claim management, interfacing issues in operation and after-sale services. His professional legal skill, extensive experiences and excellent communication skill impressed his clients. Andy is ranked as one of band 4 lawyers in Healthcare by Chambers & Partners in 2024. Andy speaks Chinese and English fluently.

Industry Sector Expertise

Andy specializes in mergers & acquisitions, licensing projects, clinical study projects, anti-bribery, data protection, anti-trust, advertisement, and regulatory requirements with a focus on the industries of life sciences and healthcare (pharmaceuticals and medical devices).

Expert in these Jurisdictions

Mainland China

Languages Spoken

Mandarin and English

Experience

Projects and Licensing

•Advised Siemens Healthineers on the Shanghai proton & heavy ion project

•Advised ProTom on proton therapy collaboration projects with a Chinese partner

•Advised Danaher on its investments in life sciences and diagnostics sectors in China

•Advised Lima on setting up their medical device businesses in China (structuring, WFOE setup, obtaining operation permit)

•Represented AB Sciex in connection with the joint venture relating to reagents R&D and production with Dian Diagnostics (300244), a China listed company

•Advised AB Sciex on licensing its life sciences devices to some China manufacturers

•Advised Avellino (a Korean and US based DNA testing service provider) on establishing its DNA testing business in China (regulatory affairs, business model adoption, cooperation with labs and distributors, WFOE establishment, trademark registration etc.)

Clinical and HGR

•Advise Danaher on China’s human genetic resource (HGR)

•Advised Beigene on clinical trial dispute matters

•Advised KCI, a 3M subsidiary, on its clinical trial project in China (including HGR filing)

•Advised Sinovant Sciences on China GCP and clinical trial contract

•Advised Sanofi on its daily clinical operation

Advertisement

•Advised Omron on advertisement matters

•Advised Zeiss on advertisement matters

Regulatory

•Advised Virbac on veterinary products

•Advised 3M healthcare business group on regulatory and compliance issues

•Advised MSD on drug related new business models and health data issues

•Advised Arthrex on its daily operation

•Advised Burning Rock Dx on HGR, scientific research and clinical projects and business structures

•Advised Philips on legitimacy and compliance of business models

•Advised Boston Scientific on some new business models

•Advised Siemens Healthcare on legitimacy and compliance of certain proposed new business models

•Provided daily legal support to Beckman Coulter (an American IVD manufacturer) and advised on legitimacy and compliance of promotional plans

•Advised Haemonetics on regulatory compliance programs

•Provided compliance training and advisory services to United Imaging and advised on imaging data collection and transfer issues

•Advised Ortho Clinical Diagnostics (an IVD manufacturer, a business spin-off from Johnson & Johnson) on legitimacy and compliance of certain proposed business models

•Advised DeltaHealth Hospital on its daily operation and large medical device procurement, and legitimacy and compliance of certain promotional plans and patient data protection

•Advised Kavo-Sybron (a dental device manufacturer) on using the business model of ODM

Standardization

•Advised Medtronic on model terms of contract templates

•Provided daily legal support to Danaher (an American corporation investing and managing portfolio businesses mostly in the healthcare industry) and developed model terms of distribution agreement for its business sectors in China

•Advised Leica Microsystems (a microscopes manufacturer) on distribution agreement and daily operation

•Advised Kavo-Kerr (a dental device manufacturer) on its Suzhou plant construction contract

•Advised HOYA (an intraocular lens manufacturer) on its distribution contract in China

•Advised SYSMEX on its distribution contract in China

•Provided compliance training to VIVA, a subsidiary of URGO (a French healthcare group)

Clients

Danaher / Sanofi / Siemens / Beckman Coulter / Sciex / Cepheid / Leica / Radiometer / Mammotome / Omron / Zeiss / Virbac / 3M Healthcare/ Philips / Protom / Medtronic / OcuMension / Ortho Clinical Diagnostics / Lima / Fresenius

Education

Awards