Secure Made‐in‐China Approval by Moving Production to China

The China–United States tariff rally has taken center stage. No one knows when we will see the light at the end of the tunnel. Shifting duties push import‑export costs up and down, adding risk and expense for hospitals and patients.

To stay competitive, China has been rolling out policies that ease local production, which affects the import of medical devices from foreign manufacturers. Don’t tell me that you aren’t affected. Let’s dive in!

Why should foreign manufacturers care about local production?

China’s public hospitals now prioritize “国产优先” (“domestic first”) due to volume-based procurement and “Made-In-China 2025” industrial policy. You are losing market share if your stent or high‑value consumables are still arriving by plane, while your competitor’s products have already reached the hospitals. Let it sink…

The National Medical Products Administration (NMPA) saw the pain points and dropped a new scheme in 2020 to encourage foreign manufacturers to consider establishing their production base in China - the new permanent home.

The NMPA revised the scheme last month to crank the door wider, allowing the sister companies under the holding company to step through, and sweetening the paperwork rules. Okay, what is the catch?

Are you eligible for this pathway?

Not every foreign manufacturer or registrant of medical devices will be entitled, as it is subject to meeting a couple of conditions. You can leverage this scheme if you fulfill all 4 requirements as below. Of course, you also need to have a local production site in China to start with!

• The foreign registrant holds a valid Class II or III China medical device approval certificate ✅

• China’s production entity is invested by a foreign medical device registrant or has the same owner as the foreign registrant ✅

• No change on the product design, raw materials and main manufacturing processes✅

• The QMS of the China manufacturing site is substantially equivalent to the original manufacturing site overseas✅

• You outsource the production to a CMO in China❌

• The original approval certificate has expired or been revoked❌

What are the benefits of doing so?

Transferring your production site to China lets you reuse much of your original NMPA dossier. This will cut down the paperwork efforts. It puts a “Made‑in‑China” badge on the label, so your device can compete head‑to‑head with local brands in price‑sensitive tenders while you save on labour, logistics and other supply‑chain costs. And when the dust settles, NMPA issues a brand‑new domestic approval certificate that opens doors across Chinese hospital procurement. You have more options by owning two certificates - it allows you to choose how you want to present yourself in the market.

What else do you need to consider?

This approach is slightly different from the ordinary registration pathway. New requirements may lead to additional loopholes. Here are the major ditches you need to additionally consider before you file for the transfer:

• Evidence documents on the company ownership, equity distribution, relationship between sister companies, etc.

• China’s production site must be compliant with cGMP

• China’s production site has established a QMS that is strongly aligned and equivalent to the foreign registrant’s system, and its traceability

• Establishment of China's post-market surveillance and registration of Chinese UDI

This scheme is suitable for multinational corporations that want to maintain their competitiveness and value proposition in the Chinese market.

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(Psst… Forward this newsletter to your supply‑chain manager before the next procurement round.)

Disclaimer: This content is created solely in my personal interest and do not reflect the views, opinions, or policies of my employer or any other organizations I am affiliated with. The information provided is for informational purposes and should not be construed as professional advice. Neither I nor my employer is liable for any use of this content. This newsletter is non-commercial and does not compete with my employer’s interests. Any references to regulatory updates or guidance are based on publicly available information and are not intended to infringe upon proprietary or confidential content.