How to Check Whether a Dermal Filler or Botulinum Toxin Is Approved by China's NMPA (2026 Step-by-Step)

Short answer: In China, a hyaluronic acid (HA) dermal filler is a Class III medical device and botulinum toxin type A is a drug, so you check them in different NMPA databases. Take the number printed on the box (a device number such as 国械注进… or a drug number such as 国药准字S…). Search it on the NMPA data query site (nmpa.gov.cn/datasearch). Then check that the registrant, model/specification, approved scope and expiry date all match the product in front of you.

The rest of this guide covers how to read those numbers, what each database shows, why brand names usually aren't on the certificate, and the red flags that mean a product isn't legally on the Chinese market.

Is a filler checked the same way as botulinum toxin in China?

No. The two product types fall under different laws, carry different kinds of number and sit in different databases.

NMPA Announcement 2022 No. 103 sets out how medical hyaluronic acid products are classified. HA used "as an injectable filler to increase tissue volume" is managed as a Class III device. So is HA injected into the dermis to improve skin condition (the "skin booster" category). HA fillers that contain lidocaine are classed as device-led drug–device combination products, so they still carry a device registration number.

Botulinum toxin type A is approved as a drug. Its approval number follows the drug format in the Drug Registration Regulation (see below).

How do I read an NMPA device registration number?

Article 115 of the Provisions for Medical Device Registration and Filing (SAMR Order No. 47, 2021) defines the format:

×1 械注 ×2 ××××3 ×4 ××5 ××××6

• ×1: approving authority. "国" for domestic Class III devices and for imported Class II and III devices. Domestic Class II devices use the province's abbreviation instead (e.g. 粤, 沪).
• ×2: registration type. 准 = domestic, 进 = imported, 许 = Hong Kong, Macau or Taiwan.
• ××××3: year of first registration.
• ×4: management class (1, 2 or 3).
• ××5: product classification code.
• ××××6: serial number of the first registration.

When a certificate is renewed, the year and serial number stay the same. The number is only reissued if the product's class changes.

Worked example: 国械注进20183130227 (registrant: Q-Med AB)

In the 2017 Medical Device Classification Catalogue, injectable fillers sit under 13 (passive implantable devices) → 09 (plastic and general surgery implants) → 02 (injectable fillers for plastic surgery). That is why so many HA filler numbers contain "313" after the year: class 3, code 13.

Class I devices are not registered. They are filed, and their numbers look different: ×1 械备 + year + serial (Article 116). You should never see a 械备 number on an injectable HA filler.

How do I read a drug approval number for botulinum toxin?

Article 123 of the Drug Registration Regulation (SAMR Order No. 27, 2020) sets three formats:

• Made in mainland China: 国药准字H(Z, S) + 4-digit year + 4-digit serial
• Made in Hong Kong, Macau or Taiwan: 国药准字H(Z, S)C + year + serial
• Made overseas: 国药准字H(Z, S)J + year + serial

H means chemical drug, Z traditional Chinese medicine and S biological product. Botulinum toxin is a biological product, so expect an S, plus a J if it is made overseas. The approval number does not change when post-approval details are varied. Certificates issued before July 2020 used older formats for imported drugs, so you may see those in historical records.

How long is an NMPA registration valid?

• Devices: a registration certificate is valid for 5 years. To renew, the registrant must apply at least 6 months before expiry (Article 22, Regulations on the Supervision and Administration of Medical Devices, State Council Order No. 739). If the renewal is approved before the old certificate expires, the new validity period starts the day after the old expiry date (Order No. 47, Article 84).
• Drugs: a drug registration certificate is also valid for 5 years, and the holder must apply for re-registration 6 months before expiry (Drug Registration Regulation, Articles 12 and 82).

One practical detail: under Order No. 47, Article 112, a "registered device" is one made within the certificate's validity period and consistent with what the certificate approves. Stock made while the certificate was valid is treated differently from stock made after it lapsed.

How do I check a filler or toxin step by step?

1. Get the number from the product itself. Article 39 of Order No. 739 requires the label and instructions of Class II and III devices to show the registration certificate number. Every Chinese-labelled HA filler should therefore carry it. For botulinum toxin, the drug approval number is on the carton and package insert. A supplier's word or a photo of a certificate is not a substitute for the number on the box.

2. Search the NMPA data query site. Go to nmpa.gov.cn/datasearch.

• Fillers: use the medical device section. On the record pages we checked, domestic products are labelled 境内医疗器械（注册） and imported products (including Hong Kong, Macau and Taiwan) 进口医疗器械（注册）.
• Botulinum toxin: use the drug section, under 境内生产药品 (made in China) or 境外生产药品 (made overseas).

Search by the full number. If you don't have the number, search by registrant name or generic name (see the next section). Labels on the site change from time to time, so look for the closest match.

3. Compare the record with the product. A device record shows the registration number, registrant name and address, manufacturing address, agent (for imports), product name, class, models/specifications, structure and composition, scope of application/intended use (适用范围/预期用途), storage and shelf life, approval date, validity date and change history. Check that:

• the registrant and manufacturing address match the label;
• the exact model and specification on the box is listed;
• the scope matches how the product is being used and promoted.

Scope matters commercially. Advertising for a medical device may not go beyond the scope on its registration certificate (SAMR Order No. 21, Article 6). Two certificates in the table below share the generic name 注射用修饰透明质酸钠凝胶 and the same registrant, Q-Med AB, but approve different uses. One covers mid-dermal correction of nasolabial folds. The other also covers nasal dorsum and radix shaping, injected supraperiosteally.

4. Check validity and change history. Look at the "valid until" date and the change log (变更情况). Changes to the registrant name, manufacturing address, models or scope all show up there. If the label doesn't match the current record, find out why before buying.

5. For imported products, note the agent. Imported device records list an agent (代理人), a company in China designated by the overseas registrant. This tells you who is legally responsible locally, which is useful when you assess distributors.

Why can't I find the brand name on the certificate?

Usually it isn't there. Device certificates record the generic name (通用名称), and the brand is often absent. Most HA fillers are registered under one of a handful of generic names: 注射用修饰透明质酸钠凝胶, 注射用交联透明质酸钠凝胶, or a version "含利多卡因" (with lidocaine). One manufacturer may hold several certificates with the same generic name, one for each product in its range.

This is the core practical difficulty. A search for a marketing name often returns nothing, while a search for the generic name returns dozens of records. What works:

1. Find the registrant (the legal manufacturer) from the label or the supplier.
2. Search by registrant name, or by generic name plus registrant.
3. Match the model/specification and the approved scope against the product you have.
4. Confirm with the full registration number on the box.

Some certificates do include a brand in the product name, such as the Belotero and Princess rows in the table below. Many don't. For example, Q-Med AB, the manufacturer of the Restylane range, holds several certificates that list only the generic name. Without the number or the model, you can't tell which certificate covers which product.

What do real HA filler certificates look like?

The table below is a snapshot of the NMPA database taken 19 June 2026. Verify against the live database before relying on any row. Names are shown as recorded on the certificate.

The table shows all three registration types: 进 (imported), 准 (domestic) and 许 (Hong Kong, Macau or Taiwan; this registrant is based in Taiwan). Some first-registration years go back to 2015 and 2017 while the validity dates run to 2028–2029. That is renewal at work: the number stays the same and the validity period rolls forward.

Why you must re-check the live database: the Belotero Balance Lidocaine example. In the 19 June snapshot, certificate 国械注进20213130421 is valid until 20 October 2026, less than two weeks after this article's publication date. That doesn't mean the product is leaving the market. The registrant may have applied for renewal on time. NMPA's own FAQ says renewal details are published only once the renewed certificate takes effect, and a renewal approved in time starts the day after the old expiry. So for a short period the live database may still show the old date. Check the record again after the expiry date, or ask the registrant or its agent in China for the renewal approval.

What are the red flags that a product is not legally approved?

• An injectable HA filler with a 械备 (Class I filing) number or a provincial Class II number. Injectable HA fillers are Class III (NMPA Announcement 2022 No. 103), and Class III numbers start with 国械注. A Class I filing or a number starting with a province abbreviation cannot cover an injectable filler.
• An "injectable" with a cosmetics number (numbers containing 妆). Under Article 3 of the Regulations on the Supervision and Administration of Cosmetics, cosmetics are products applied to the body surface by rubbing, spraying or similar methods. Anything injected is outside that definition. NMPA Announcement 2022 No. 103 separately classes HA injected into the dermis to improve skin condition as a Class III device.
• "Korean original" or "European original" stock with no 国械注进 certificate. Approval by MFDS, the FDA or under a CE mark does not authorise sale in China. Imported Class II and III devices need their own NMPA registration (Order No. 47, Article 8).
• An expired certificate, or a product made after expiry. Check the validity date against the production date on the box.
• A mismatch between registrant, manufacturer, model or scope on the label and in the database record.
• A number that doesn't appear in the database at all, or that belongs to a different product.

What is different about botulinum toxin?

• It is managed as a toxic drug. The former SFDA and the Ministry of Health added botulinum toxin type A and its preparations to toxic-drug management in 2008 (国食药监办〔2008〕405号, Notice on Listing Botulinum Toxin Type A under Toxic Drug Management). Wholesalers may sell it only to medical institutions, and retail pharmacies may not sell it. A 2016 notice (食药监办药化监〔2016〕88号) narrowed this further: sales go through distributors designated by the manufacturer or importer, only to institutions holding a 医疗机构执业许可证 (including medical aesthetics institutions). Since 2023, NMPA and the National Health Commission have also required traceability codes from manufacturer to point of use.
• It is prescribed, not sold over the counter. The 2008 notice requires physicians to prescribe it according to the label, with each prescription limited to two days' dosage.
• It cannot be advertised to the public. Article 15 of the Advertising Law bans advertising of medical toxic drugs and other special drugs. It allows other prescription drugs to be advertised only in medical and pharmacy journals designated by the health and drug authorities. Either way, consumer-facing ads for botulinum toxin are off-limits.
• How to look it up. Search the generic name 注射用A型肉毒毒素 in both drug databases (境内生产药品 and 境外生产药品). Compare the approval number, marketing authorisation holder, manufacturer, strength and validity with the carton. Supplier price lists and online "approved product" lists change; the database is the reference.

Is there a faster way to match a brand name to its certificate?

Matching marketing names to generic-name certificates is the slow part. Medcxy's product lookup page maps brand names to the generic names on NMPA certificates and shows the registration record. It requires a free account. Whatever tool you use, confirm the final answer against the live NMPA record.

Registration data changes as certificates are renewed, varied or cancelled. For purchasing, distribution or advertising decisions, rely on the live NMPA database and the documents issued to the registrant.

Sources

• NMPA data query site: https://www.nmpa.gov.cn/datasearch/home-index.html; data query FAQ (renewal publication timing): https://www.nmpa.gov.cn/datasearch/search-help.html
• 医疗器械注册与备案管理办法 (SAMR Order No. 47, 2021), Articles 8, 84, 112, 115, 116: https://www.gov.cn/gongbao/content/2021/content_5654783.htm
• 医疗器械监督管理条例 (State Council Order No. 739, as amended 2024), Articles 22 and 39: https://www.nmpa.gov.cn/xxgk/fgwj/flxzhfg/20250416172904188.html
• 药品注册管理办法 (SAMR Order No. 27, 2020), Articles 12, 82, 123: https://www.samr.gov.cn/zw/zfxxgk/fdzdgknr/fgs/art/2023/art_3275cb2a929d4c34ac8c0421b2a9c257.html
• NMPA Announcement on the classification of medical hyaluronic acid products (2022 No. 103): https://www.nmpa.gov.cn/xxgk/fgwj/xzhgfxwj/20221114155641144.html
• 医疗器械分类目录 (2017, Announcement No. 104): https://www.nmpa.gov.cn/xxgk/ggtg/ylqxggtg/ylqxqtggtg/20170904150301406.html; catalogue adjustment table (2022 No. 30) showing 13-09-02: https://www.nmpa.gov.cn/directory/web/nmpa/images/1648622768279070699.docx
• 化妆品监督管理条例 (State Council Order No. 727), Article 3: https://www.nmpa.gov.cn/xxgk/fgwj/flxzhfg/20250416144446121.html
• 关于将A型肉毒毒素列入毒性药品管理的通知 (国食药监办〔2008〕405号): http://www.npc.gov.cn/npc/c2/c188/c219/201905/t20190523_168369.html
• 总局办公厅关于加强注射用A型肉毒毒素管理的通知 (食药监办药化监〔2016〕88号): https://www.nmpa.gov.cn/xxgk/fgwj/gzwj/gzwjyp/20160708155201196.html
• Notice on traceability for injectable botulinum toxin type A (药监综药管〔2023〕3号): https://www.nmpa.gov.cn/directory/web/nmpa///xxgk/fgwj/gzwj/gzwjyp/20230119082839119.html
• 中华人民共和国广告法, Article 15: https://www.nmpa.gov.cn/xxgk/fgwj/flxzhfg/20230328161808137.html
• 药品、医疗器械、保健食品、特殊医学用途配方食品广告审查管理暂行办法 (SAMR Order No. 21), Article 6: https://sjfg.samr.gov.cn/law/file/pdf/3235243/1663660163213.pdf

Related reading

• In how many countries is a filler approved? A practical cross-border regulatory comparison (NMPA/FDA/CE/PMDA/MFDS)
• Medical aesthetics ad compliance: 10 high-risk claims to avoid in 2026