Myunghoon Paik

Hoon is an associate working in Kennedys’ products law and life science team in London.

Hoon is a dual qualified lawyer in England and Wales (UK) and New York (US). Prior to joining Kennedys, Hoon worked as legal counsel for a global medical device company in London providing strategic advice and practical solutions in Latin America, Europe, APAC, the Middle East and Africa to support business growth and help mitigate corporate and products law risks.

Hoon’s practice focuses on multi-jurisdictional regulatory, commercial, corporate, investigation and sanctions matters in products law and life science.

Hoon actively advises clients in a vast number of fields and in relation to a wide range of products, including medical devices, in-vitro diagnostics, pharmaceuticals, biotechnology, food, chemicals, cosmetics, packaging, toys, tobacco, drone, telecommunication, home appliances, machinery and sports goods. He has been advising clients in respect of the following topics:

• Market entry including business setup, due diligence, product launch and obtaining regulatory authorisations and licences.
• Market access including reimbursement and product marketing.
• Preceptorship and proctorship.
• Clinical investigation of medical devices and clinical trials of medicinal products.
• Product compliance including borderline classification, quality management system, conformity assessment and product marking/labels.
• Post-market surveillance including vigilance, product recall/withdrawal, reporting to authorities, risk assessment and monitoring.
• Investigation including product safety incident, regulatory inquiries from competent authorities and industrial codes of conduct.
• Trade sanctions including UK Office of Financial Sanctions Implementation (OFSI), US Office of Foreign Assets Control (OFAC) and the EU Commission’s sanctions regimes.
• Various types of commercial contracts including sale and distribution agreement, tender agreement, contract manufacturing agreement, logistics agreement (3PL/4PL), clinical investigation/trial agreement and HCP agreement.