New year means new requirements!

China has just issued a notice updating the Medical Device Classification Catalogue.

This matters if you have an NMPA product submission in progress, or if you already hold a valid filing or registration.

The update took effect on January 4, 2026.

This week, I’ll break down which products are impacted, what has changed, and what it means for manufacturers.

🍜 Which product categories are affected?

NMPA updated product descriptions, intended uses, device examples, and key terminologies.

These indicate whether the changes in 31 device categories affect the risk class.

If you know the product code (6 digits), let’s see if your product is on the list.

🍜 Non-active surgical instrument

02-06-01 Closure clips

• Change category
  Product description, product examples, sub-type in scope, intended use. Risk class remains identical.

• What changed
  Class III: description expands to allow metal or polymer. It also adds biodegradable magnesium metal closure clips as a product example.

  Class II/I: add that it’s not absorbable by the human body, only short-term retention < 30 days is allowed, or to be removed immediately.

02-12-03 Delivery applicator

• Change category
  Risk class and product example.

• What changed
  Revise the name of the single-use sterile delivery applicator and downclassifies it from Class III to Class II.

🍜 Respiratory, anesthesia and emergency devices

08-06-08 Nasal oxygen cannula

• Change category
  Product description, product example alignment.

• What changed
  Specify that sterile products are Class II. Adds “sterile” to existing product examples. Class I non-sterile variants remain unchanged.

🍜 Physical therapy devices

09-06-02 Ultrasound therapy accessories (isolation and acoustic membranes)

• Change category
  Risk class, product description.

• What changed
  Sterile acoustic isolation membrane is now treated as Class II, while non-sterile versions remain Class I.

🍜 Non-active implantable devices

13-01-02 Absorbable bone fixation devices

• Change category
  Product description.

• What changed
  Class III: clarify that materials can be PLA or absorbable copolymers (and composites).

13-02-01 Sports-medicine soft tissue repair & reconstruction implants

• Change category
  Product description, intended use, and product examples.

• What changed
  Class III: expand product forms to include membrane and patch-type designs, as well as soft-tissue repair. Adds tendon and rotator cuff-related patches as examples.

13-08-02 Middle ear prostheses

• Change category
  Intended use, product examples, risk class split.

• What changed 
  Ossicular chain reconstruction and stapes immobility prostheses remain within the original scope (Class III). Ventilation/drainage tubes are separated and downclassified to Class II.

13-10-03 Collagen scaffold materials

• Change category 
  Intended use, product examples.

• What changed
  To include skin and dermis in the indications. Adds a cartilage-repair scaffold example for Class III.

13-11-05 Intra-articular chitosan-containing fluid

• Change category
  Product description (composition).

• What changed
  Allow chitosan derivatives (not only chitosan) for Class III.

🍜 Infusion, care and protection devices

14-10-14 Collagen patch dressing

• Change category 
  Intended use.

• What changed 
  Expand to cover the wound and skin conditions for collagen patch dressings.

14-15-03 Nasal care devices

• Change category

  Intended use restriction, product examples.

• What changed 
  Narrow the scope by removing nasal secretion cleaning and electric suction from examples.

🍜 Dental devices

17-03-08 Tooth whitening tool & bleaching agent

• Change category
  Intended use restriction.

• What changed
  This is not a substitute for toothpaste for daily cleaning.

17-09-06 Abrasive and polishing materials

• Change category
  Intended use restriction.

• What changed: 
  Intraoral use must be performed by qualified professionals. It cannot be used for daily cleaning like toothpaste.

17-09-11 Dental separating agents

• Change category
  Intended use restriction.

• What changed 
  It is not for intraoral use.

17-10-03 Desensitizers

• Change category
  Intended use restriction, product example naming alignment.

• What changed 
  This is not a substitute for toothpaste for daily cleaning. The product examples are for dental use.

17-10-04 Anti-caries materials

• Change category 
  Intended use restriction, product example naming alignment.

• What changed
  It is not a substitute for toothpaste for daily cleaning. The product examples are for dental use.

17-10-06 Tooth whitening materials

• Change category

  Intended use restriction.

• What changed 
  It is not a substitute for toothpaste for daily cleaning.

 🍜 Assisted reproduction and contraception devices

18-01-07 Vaginal irrigation & medication applicators

• Change category
  Secondary sub-category refinement, new product examples.

• What changed 
  Wording changes from cleaning to irrigation. Adds single-use sterile vaginal irrigator as examples for Class II and non-sterile vaginal irrigator for Class I.

18-01-12 Gynaecological examination pads

• Change category 
  Intended use restriction.

• What changed
  Split between sterile (Class II) and non-sterile (Class I). Class I non-sterile products are not menstrual hygiene products.

18-01-13 Medical gynaecological gels

• Change category 
  Secondary sub-category terminology.

• What changed: 
  Category name changes to “medical gynaecological gels”. The scope, description, and classification remain unchanged.

18-04-01 Gynaecologic physical therapy devices (ultrasound therapy)

• Change category
  Intended use wording refinement.

• What changed
  It is intended for gynaecologic tissues or organs related disease and wound healing without tissue degeneration for Class II ultrasound therapy device.

18-04-01 Gynaecologic physical therapy devices (balloon hemostasis product)

• Change category 
  Product examples

• What changed
  Add balloon uterine stents as a product example for Class II.

18-04-02 Gynaecologic prosthetic devices (uterine pessary)

• Change category
  Intended use, product example.

• What changed: 
  Intended use expands to cover placement sites (vagina, cervix, uterus, fallopian tube) for Class II. Specify duration of use < 30 days. Remove the minimum 24-hour retention time. Adds vaginal stent as a product example.

18-04-02 Gynaecologic prosthetic devices (therapeutic pessary)

• Change category
  Intended use.

• What changed: Specify the duration of use <30 days, instead of >24 hours and <30 days.

18-07-03 Assisted reproduction-related devices

• Change category
  Secondary sub-category refinement, product description.

• What changed
  Wording changes from “micro tools” to “related tools”. Specifies that it is assisted reproduction for human use.

18-07-04 IVF solution

• Change category
  Product description, product examples.

• What changed 
  Add broader wording on the energy source. It includes granulocyte removal solution as a product example.

18-07-05 Assisted reproduction specialized equipment

• Change category 
  Product description alignment.

• What changed 
  Align the description of embryo and time-lapse incubators. The scope and classification (Class II) remain unchanged.

🍜 Rehabilitation devices

19-03-01 Medical wheelchairs

• Change category 
  Risk class split.

• What changed
  Manual wheelchairs are reclassified as Class I. The powered wheelchairs remain as Class II.

🍜 Traditional chinese medicine

20-03-11 Acupoint pressure stimulation devices

• Change category 
  Product description.

• What changed
  The product must be sterile. It must not deliver infrared radiation, magnetic, or similar therapeutic effects. Should not contain ingredients that exert pharmacological, immunological, or metabolic effects.

🍜 Clinical laboratory instruments

22-05-03 Nucleic acid amplification analyzers

• Change category
  Product description, intended use, product examples

• What changed
  The composition can include functional modules, such as a digital PCR chip micro-reaction unit generation, and a nucleic acid amplification module. The Poisson distribution statistical method is used for quantitative analysis of nucleic acid copy number concentration. Add digital PCR systems as an example.

22-10-08 Biochip analyzers

• Change category
  Product description, intended use exclusion, product examples.

• What changed
  Includes software and power supply in addition to the host and photoelectric signal acquisition module as compositions. The semi-quantitative and quantitative analyses compare results against calibration standards. Refine the definition of biomolecular microarrays. It doesn’t consist of components related to gene sequencing and nucleic acid amplification analysis. Add protein microarray reactors and bioarray readers as product examples.

🍜 What does it mean for manufacturers?

Most of the devices in this notice were downclassified or stayed the same. Only one item moved up.

So, which product categories are at risk right now?

Upclassification

Ultrasound therapy accessory (09-06-02) now sits in a higher risk class (Class I → II). This applies to the sterile acoustic isolation membrane.

If your product moves to a higher class, you will need a new Class II registration.

There is also a working draft that may allow renewal under certain conditions before your current certificate expires.

I covered the details in my previous analysis.

Downclassification

Delivery applicator (02-12-03) and middle ear prostheses (13-08-02) now belong to a lower risk class (Class III → II).

Manual wheelchairs (19-03-01) have now become Class I instead of Class II.

It indicates that the device and technology are mature and stable.

This is good news for manufacturers.

It can simplify your future regulatory workload and shorten change and renewal timelines.

But you still need to manage the transition correctly.

Here is what to do, depending on the stages of your registrations.

🍜 Registration is ongoing

If your application has been accepted, but approval has not yet issued, NMPA will continue to review under the original accepted category.

This only applies to initial registrations and renewals already in process.

When the registration is approved, the adjusted category or risk class will appear in the remarks section of the certificate.

You do not need to take action until your next renewal cycle (e.g. 5 years).

Keep reading if your product was already approved before the adjustment took effect.

🍜 Approved products are downclassified

Your current NMPA registration remains valid until it expires, even if the device has been downclassified from Class III to Class II, or Class II to Class I.

When renewal is due, submit the renewal application according to the new risk class within six months before the certificate's expiry date.

The new certificate will show the updated category or classification.

However, an additional step is required for downclassification to Class I.

Your authorized representative must complete a Class I product filing instead of a registration renewal.

The process is fast and takes less than a month.

The Class I filing package is lighter than a registration renewal. There is no administrative fee.

🍜 Registration change for approved products

You should submit a registration change to the original registration authority if you make any significant changes during the certificate validity period.

If your existing certificate has been issued under the old catalogue, NMPA will usually reference the updated risk class in the remarks of the change approval documents.

Check out my previous post for a deeper dive.

It further elaborates specific scenarios for both upclassification and downclassification in the draft.

That’s it for today.

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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.