Market Entry & Launch
China Market Entry & Launch
From registration to sales — we help turn compliance into commercial success.
BiomenGroup supports international MedTech companies in not only entering China’s regulatory system, but also localizing, listing, and launching their products into the healthcare market. From regulatory approval to tendering, reimbursement, and channel building — we provide an end-to-end market entry strategy tailored to imported medical devices.

How to Localize in China

Why localization matters — and how to do it right.

Localization improves your commercial competitiveness in China, especially when it comes to tendering eligibility, pricing, and hospital procurement access.

Key options for imported devices：
● Become a “domestic brand” via OEM or local manufacturing
● Leverage the China Market Authorization Holder (MAH) system to shift from importer to local registrant
● Compare local production vs direct import paths based on cost, lead time, and strategic control

BiomenGroup provides strategic consulting on localization models, OEM registration, and MAH setup.

Commercial Access

Understanding China’s unique market entry mechanisms

Entering the Chinese market goes beyond regulatory approval. You’ll also need to navigate:

● Provincial and national tendering platforms
● Medical device reimbursement inclusion (where applicable)
● Government procurement processes
● Pricing policies, bidding documentation, and access rules

These systems determine whether your product can be purchased by hospitals.

We support you with pricing strategy, bidding dossier preparation, and local policy compliance.

Distribution & Sales Channels

Sales execution is everything — especially in China’s hospital-driven market.

Why this matters:
● Hospitals rely heavily on approved vendor lists, local relationships, and platform listing
● Foreign companies often struggle to identify reliable distributors or build compliant order systems
● Sales channel readiness affects actual revenue flow — not just approval

BiomenGroup can act as your exclusive China distributor or help you build a regional network with graded management. We assist with listing, ordering, logistics, and sales compliance.

Timeline & Cost

Plan your launch with clear expectations.


We provide transparent estimates on:
● Registration timelines (by product class)
● Budget ranges (regulatory + commercialization)
● Resource requirements (testing, clinical, documentation)

Use our planning tools to evaluate ROI and avoid common delays. Our case studies show how strategic planning can save up to 6–9 months.
View Timeline & Cost Estimates ▸
All
View Timeline & Cost Estimates ▸