Hansem Global: Your Global Partner in Pharmaceuticals, Biotech, and Healthcare

2026.11.06

The pharmaceuticals, biotechnology, and healthcare industries in Korea hold significant growth potential in the global market. Many companies are expanding into international markets, leveraging Korea’s capabilities in biopharmaceutical research and development. However, effective communication strategies and precise translations are essential for success. Particularly in the pharmaceuticals, biotechnology, and healthcare sectors, where specialized documents are abundant and regulations are complex, accurate and effective translation is crucial.

Medical Device IFU & Labeling for US Market Entry (FDA 510(k))

2026.10.30

For a medical device, the manual itself can hold up market entry. In regulatory terms the user manual is the IFU (Instructions for Use) – a core document tied directly to product clearance, labeling, and usability evaluation, and one of the most common reasons an FDA 510(k) submission stalls. This second installment of our Manuals Under Regulatory Scrutiny series maps the IFU and labeling requirements that medical device manufacturers most often run into when pursuing FDA 510(k), Health Canada, and MDSAP, and explains why regulatory strategy and document production must be managed together.

What Information Does the FDA Expect in Your IFU?

2026.10.30

A Practical Guide to Preparing Instructions for Use (IFU) for U.S. Medical Device Marketing Authorization

How to Market a Medical Device in the U.S. and What You Need to Know

2026.10.23

The U.S. remains one of the most competitive and tightly regulated markets for medical devices. But even with a high-quality product, many companies face costly delays—not because of flaws in technology, but due to gaps in documentation or misunderstanding of regulatory requirements.