Domestic Manufacturer Registration Pathway in China: Classification to Production Licence

1. Key takeaways

A manufacturer established in China works two parallel tracks, product registration and production licensing, at different administrative levels.

• Class I: product filed with the municipal-level medical products administration, production filed with the same authority.
• Class II: product registered with the provincial administration, production licence from the same province.
• Class III: product registered with the National Medical Products Administration (NMPA), production licence still provincial.

Three time anchors frame the work: documents reach technical review within 3 working days of acceptance, a decision follows within 20 working days of the review opinion, and the certificate runs 5 years with renewal filed 6 months before expiry. Three variables need settling first: whether a classification determination is required, whether testing is in house or commissioned, and whether clinical evaluation uses the exemption route, an equivalence comparison or a clinical trial.

The GRZAN view. Schedule loss starts upstream of review, in registration unit division and technical requirements, where one rework cycle costs three to six months.

2. Legal basis

Administrative regulation. Regulations on Supervision and Administration of Medical Devices, State Council Order No. 739, promulgated 9 February 2021, effective 1 June 2021. Article 6 sets three risk classes with their definitions, rules and catalogue; Articles 13 and 14 make Class I a filing and Classes II and III registrations, place lifecycle quality on the registrant and list seven document categories; Articles 15(1) and 16(1) assign Class I to the municipal authority, Class II to the province and Class III to the NMPA. Articles 17(2) and 18(1) fix 3 working days for transfer to technical review and 20 working days for a decision after the review opinion. Article 20(1) lists five registrant duties, from the quality system to traceability and recall; Article 22 gives 5-year validity, renewal 6 months before expiry and three grounds barring renewal. Articles 23(2) and 32 set 20 working days for class confirmation and for the production licence, valid 5 years, and Article 34 permits self-manufacture or contract manufacture.

Departmental rules. SAMR Order No. 47, on registration and filing, promulgated 26 August 2021, effective 1 October 2021: Article 8 sets the filing and review levels; Article 26 limits technical requirements to specifications that can be objectively judged on the finished device; Articles 33 and 34 make clinical evaluation the principle with two exemptions, and Article 36 sets the documents for predicate comparison and trials; Article 41 requires deficiencies in full at one time, supplements within 1 year and refusal otherwise; Article 45 requires trials within 3 years of approval; Article 79 separates variation from 30-day filing; Article 117 gives electronic certificates equal effect; Article 124 repeals Order No. 4 of 30 July 2014.

SAMR Order No. 53, on production, promulgated 10 March 2022, effective 1 May 2022, requires licences for Class II and III and filing for Class I (Article 4); a 20-working-day decision with the certificate within 10 working days, the on-site inspection being combinable with the registration system inspection (Article 13); 5-year validity (Article 14); registered-item changes within 30 working days (Article 16); renewal at 90 to 30 working days before expiry (Article 17); and inspection within 3 months of Class I filing (Article 22). IVD reagents follow SAMR Order No. 48, promulgated 26 August 2021, effective 1 October 2021, read with Article 121 of Order No. 47.

Normative and technical documents. The Good Manufacturing Practice, NMPA Announcement No. 107 of 2025, issued 4 November 2025 and effective 1 November 2026, runs to 15 chapters and 132 articles, adds quality assurance, verification and confirmation and contract manufacturing and outsourcing, and repeals Announcement No. 64 of 2014. NMPA Notice No. 50 of 2022 sets four inspection outcomes; Announcement No. 121 of 2021 covers submission and certificate formats; Announcement No. 126 of 2021 and its 16 September 2025 guideline cover self-testing. The 2025 Clinical Evaluation Exemption Catalogue, Notice No. 19 of 2025, covers 1,047 products, with 28 additions and 25 revised descriptions. Guobanfa No. 53 of 2024 sets 24 measures in five areas and a system suited to innovation by 2027; Announcement No. 63 of 2025 addresses high-end devices.

NMPA fees are CNY 153,600 initial, CNY 50,400 variation, CNY 40,800 renewal and CNY 43,200 for a high-risk trial application, with innovative small and micro enterprises exempt. Practical estimate. Class II fees are set provincially and vary; figures of CNY 40,670 per registration unit appear in some provinces, so confirm the local standard.

3. Expert insights

The registrant system separates certificate from factory, not responsibility. Article 20(1) keeps the quality system, post-market study, adverse event monitoring and traceability with the registrant even when Article 34 permits contract manufacture. The contract manufacturer answers for its production activities and accepts supervision. Even fully outsourced, the registrant needs design transfer records, supplier audits, release procedures and traceability.

The clock has three layers, and that is where schedules break. Variability sits in the middle: under Article 41 deficiencies arrive in full at once, the applicant has 1 year for a single submission, and expiry ends review with a refusal. That year is a hard limit, so a tracker covering document, department, data source and estimated days should be reviewed weekly.

The good manufacturing practice effective 1 November 2026 targets three recurring weaknesses. Quality assurance now guarantees system effectiveness rather than document control. Verification and confirmation puts process, cleaning and software validation beside equipment qualification. Contract manufacturing and outsourcing makes clear that outsourcing still requires proof of control, while Article 6 encourages artificial intelligence, information technology and unique device identification.

Exemption from clinical evaluation is not exemption from documentation. The 2025 catalogue covers 1,047 products with 28 additions. Under Article 36 the equivalence route still needs a predicate comparison, analysis of predicate clinical data, and scientific evidence where differences exist; differences in material, structure, intended use or key performance require non-clinical or clinical support.

Electronic certificates carry equal effect, and three-way consistency is a new inspection entry point. Article 117 confirms parity with paper, while letting authorities compare published company information, certificate entries and the actual label and instructions.

4. Practical recommendations

• Lock the class at initiation. For products outside the catalogue, Article 23 allows a direct Class III application or a class confirmation within 20 working days.
• Divide units on four dimensions: technical principle, structure, performance specifications and intended use.
• Make specifications objectively judgeable. Article 26 requires measurable specifications; vague wording triggers deficiencies.
• Choose the testing route deliberately. Article 32 of Order No. 47 accepts in-house or commissioned reports; self-testing must meet Announcement No. 126 of 2021 and the 2025 guideline.
• Use communication early. Article 22 requires a communication system, so uncertainty belongs before acceptance.
• Combine inspections. Article 13 of Order No. 53 allows the licence inspection to merge with the registration system inspection.
• Manage certificates on a five-year cycle. Registration renewal is due 6 months before expiry, the licence window is 90 to 30 working days; track them separately.

5. Verification checklist

• □ Class confirmed in the classification catalogue.
• □ Receiving authority confirmed: municipal, provincial or NMPA.
• □ Registration unit division fixed across models.
• □ Applicable mandatory standards listed, with justifications for non-application.
• □ Technical requirements objectively judgeable, methods defined.
• □ Test report source settled, sample representativeness justified.
• □ Clinical evaluation route settled, difference evidence prepared.
• □ Quality system documents cover design, purchasing, production, control and release.
• □ Instructions and labels meet Articles 10 and 13 of the Provisions on Device Instructions and Labels, former Order No. 6, promulgated 30 July 2014.
• □ Fee budget calculated on the current NMPA catalogue.
• □ Separate trackers for certificate and licence renewal.
• □ Electronic certificate entries checked against instructions, label and product.

Regulatory information verified as at 29 October 2026 against NMPA, SAMR and State Council publications; content marked as a practical estimate has no legal effect.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the Chinese market. Our team manages National Medical Products Administration (NMPA) registrations, coordinates typetesting at qualified testing institutes, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com