A device’s risk class still can change once it hits the market. Classification isn’t carved in stone.

Real-world and post-market data tell us how people really use the product and reveal safety signals that have not shown up in the trial phase.

Early clinical evidence may not capture every hazard, especially for innovative devices. Some risks take months or years to surface.

Regulators adjust the rules to keep pace with those surprises.

The EU MDR tightened its risk-based framework. It looks at the intended medical purpose and inherent risks.

Rule 11 of Annex VIII of the EU MDR is a great example. Any software that is used for diagnostic, therapeutic, or monitoring purposes now starts at Class IIa.

Say goodbye to the old myth that “software equals low-risk Class I.”

An interesting case:

Do you know WHOOP watch now offers the Blood Pressure Insights (BPI) feature? Intent matters, as it may land in Class IIb.

Curious what the U.S. FDA said about this “Rolex”? The link is at the end of the article.

Now let’s shift our focus to China.

🍜 NMPA Draft on Adjusting the Risk Class

China’s NMPA has just published a draft update to the “Working Procedure on the Adjustment of the Classification Catalog for Medical Devices”. This is set to replace the 2021 version.

This draft matters for every manufacturer who already holds a China approval or is now preparing a dossier.

The consultation will run in parallel with the new draft classification rules released in April. Check out my previous post for details.

NMPA has mapped out all the possible scenarios of how re-classification will impact your registration when the revised risk class officially kicks in.

So, what are the key changes?

 🍜 New Registrations

The new risk class applies when you submit your application after the adjustment date.

NMPA will mark the new risk class on your new certificate if your initial registration has been reviewed under the old rules.

The transition period will shorten the validity of the new certificate. Your fresh licence may last less than five years.

You need to upgrade your registration within the transition period, not within five years.

🍜 Renewal of Existing Registrations

If your renewal falls after the re-classification date, you must renew under the new class.

When a Class II product drops to Class I, you need to switch to a Class I notification instead of a re-registration.

Good news! Because the notification process takes only one to two months. It takes much less time than renewing Class II or III.

If the risk class shifts higher, a new registration or re-registration is your only option.

A product that moves from Class I to Class II now follows the standard Class II path, and you must withdraw the old Class I filing once the new certificate is granted.

🍜 Registration Changes

If your product was approved before the adjustment of the risk class, you can file the significant changes under the original risk class.

During the transition period, NMPA will add the new class as a remark.

The change itself doesn’t extend the certificate, so plan for renewal under the new class before the transition period ends.

🍜 Dilemma of the Grace Period

A new certificate issued before a risk-class change may look safe, but you still have work to do.

If your licence expires while the transition window is still open, you may renew under the old class.

ONLY IF the device has no serious adverse events or quality incidents.

This may sound good, but the reality is the opposite.

China registration takes so long that the transition period might have ended before you receive a new certificate.

Imagine you face a gap with no valid approval. It impacts your sales, and the customer is panicking.

NMPA lets you renew to reduce that gap. Ironically, the renewed certificate still expires at the end of the grace period.

Double work for twice the cost. It is not fun.

How to avoid it? Plan your renewal or registration timing strategically. Do you need a roadmap to minimize costs? Let’s build one together.

 🍜 The Ultimate Transition Period

Devices with a higher risk class get a longer grace period.

Two years if no clinical study is needed, three years if a trial is required. The timeline is tight.

The same grace period applies to products that only become “medical devices” after the adjustment.

When the shift involves crossing the drug and medical device category, NMPA sets a grace period of at least three years but a maximum of five years.

High-risk products that pose an immediate safety concern won’t have any grace period. The tighter control starts right away. No mercy.

The new draft may be released this year, so prepare earlier!

Wonder how the new risk class will affect you and what to prepare? Book a complimentary strategy call here to find out.

🍜 Bonus Reading

What else is new?

• NMPA published two new standards on building databases, exchanging data, and sharing information for production licences and medical-device filings

• NMPA draft on the regulation registering online drug and medical device information services.

• The US FDA issued WHOOP a warning letter, stating that its band must be cleared as a medical device.

Disclaimer: This content is created solely in my personal interest and does not reflect the views, opinions, or policies of my employer or any other organizations I am affiliated with. Neither I nor my employer is liable for any use of this content. This newsletter 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.