Practical guides on medical device registration and international expansion.
Reliance is not one mechanism. In 8 markets a foreign approval is required before you can file at all; in 9 it just makes the filing cheaper. We verified 28 markets — nine of the ones we checked were wrong.
1,639 UK Responsible Persons represent 7,935 foreign manufacturers. Who they are, how concentrated the market really is, and what to ask before you appoint one.
Who can hold your registration, what class you land in, who is already there, what your approvals are worth, and how anyone actually gets paid.
Listing the multinationals captures 87% of the field in Hong Kong and 10% in China. A method that works either way.
Most assessments answer questions nobody asked. What a useful one contains — and how to tell before you commission it.
Your distributor holds your market access. The candidate list, and what each already distributes, is in the registration record.
Brazil is the region, mostly. Costa Rica's register is a manufacturing artefact, not demand. An honest read.
Regulatory due diligence before the contract. Distribution agreements in this region are hard to exit — do this first.
The specific failure modes, and when the manual approach stops working. Honest take.
The standard advice is "start with Singapore." That's not always wrong — but it's not always right either. A decision framework.
Most companies come to us with one of these four questions. Each one is a conversation, not a form.
Talk to us about your expansion plans, and see yourself in our solution.