Registration Fee Waivers for Innovative Devices of Small and Micro Enterprises

1. Key takeaways

The waiver is complete, not partial, but it applies only where two independent conditions meet. Most projects fail on the patent clock rather than on the fee argument.

• The reduction is a full exemption. The NMPA fee catalogue lists innovative device applications by small and micro enterprises as free.
• Both conditions must hold: the applicant is a small or micro enterprise, and the product is an innovative device. Meeting one alone gives nothing.
• The test for innovative sits in Article 2(1) of the Special Review Procedure for Innovative Medical Devices (Announcement No. 83 of 2018): the applicant holds a Chinese invention patent over the core technology, and the special review application falls within 5 years of grant publication. It is the only quantified constraint.
• The waiver covers the registration application. Whether variations and renewals qualify depends on the current catalogue and the receiving department, and should not be assumed.
• Amounts at stake: domestic Class III first registration CNY 153,600, import Class II CNY 210,900, import Class III CNY 308,800 (article 35). For import Class III the waiver equals twice the domestic Class III first registration fee.
• The signal value exceeds the cost value: the waiver accompanies entry into the innovative channel, which brings earlier review engagement.
• Both statuses must exist at filing. The 5-year window from grant publication has no grace period.

In our assessment, the policy is often misread as a cost-saving clause. What decides the outcome is the timing judgment on the patent window and on small-enterprise status, both objectively verifiable. Making it before filing beats arguing at payment.

2. Legal basis

Medical Device Supervision and Administration Regulations (State Council Order No. 739, promulgated 9 February 2021, effective 1 June 2021)

• Article 6: devices are classified by risk, with Class I under routine control, Class II under strict control and Class III under special measures.

Medical Device Registration and Filing Measures (SAMR Order No. 47, promulgated 26 August 2021, effective 1 October 2021)

• Article 10: NMPA grants special approval to innovative devices and priority approval to clinically urgent devices.
• Article 22: an applicant may communicate with the reviewing body before filing.
• Article 120: fee items and standards follow the finance and pricing authorities under the State Council.

NMPA Catalogue of Administrative Licensing Fees: sets the items and standards, and lists innovative device applications by small and micro enterprises as free.

Special Review Procedure for Innovative Medical Devices (NMPA Announcement No. 83 of 2018, published 2 November 2018, effective 1 December 2018): Article 2(1) requires a lawful Chinese invention patent over the core technology and a special review application within 5 years of grant publication; Article 3 sets the principles of early engagement, a dedicated reviewer and scientific review.

Practical estimate. The device rules do not define small and micro enterprise; the national SME standard applies, using headcount, revenue and assets, varying by industry. Apply the standard in force and attach an explanatory note.

Practical estimate. Whether an overseas applicant may rely on its Chinese entity’s small-enterprise status, and how an overseas entity is measured, is not distinguished. Confirm in writing before filing.

Practical estimate. Coverage of variations, renewals and trial applications follows the items listed in the current catalogue; conclusions here apply only to the expressly listed registration application.

3. Expert insights

Two conditions produce four combinations, and only one is free.

Combination three causes the most argument: the device passed the innovative review but the company exceeds the size threshold. Early engagement, a dedicated reviewer and scientific review under Article 3 still apply, but not the fee relief. Combination two is the mirror image. The policy targets the overlap of small and innovative, not small firms generally.

The five-year patent window is the hardest constraint and the most frequent failure. Article 2(1) has a title element and a timing element.

• Title: the applicant lawfully holds a Chinese invention patent over the core technology. All three qualifiers matter: China, core technology, invention patent. Utility models, designs, foreign patents and peripheral patents outside the core technology all fail.
• Timing: no more than 5 years between the patent grant publication and the special review application.

The clock starts at grant publication, not the filing or priority date, and ends at the special review application date, not the registration filing date; confusing the endpoints causes wrong assessments. Failure typically appears in high-value consumables and large equipment with early patents and long cycles, and in licensed patents where the licence date needs explaining.

The coverage of the exemption should be read narrowly. The catalogue lists the registration application of a small-enterprise innovative device as free; the registration stage otherwise contains four chargeable items.

Limit the waiver to first registration and budget the rest at standard rates; counting renewals and variations as waived creates a funding gap.

Six recurring patterns of ineligibility.

The first four can be avoided through patent planning; the last two need a check before filing.

4. Practical recommendations

• Keep a patent ledger from initiation, recording each Chinese core-technology invention patent, its grant publication date and the resulting 5-year deadline.
• Establish innovation before size. Test against Article 2(1) of Announcement No. 83 first, then check small-enterprise status.
• Count from grant publication, not filing. The start is the patent grant publication date and the end is the special review application date, and the gap must not exceed 5 years.
• Recheck size indicators before filing, using the national SME standard and the latest data.
• Budget on a first-registration basis only. Variations, renewals and trial applications are budgeted at catalogue rates.
• Have overseas applicants confirm in writing how their Chinese entity’s size maps to the threshold, and keep the reply.
• Use the channel’s communication mechanism. Article 22 allows pre-filing discussion, and the early engagement principle in Article 3 of Announcement No. 83 is best used to resolve technical difficulties up front.
• Assess the priority review route in parallel. Products in the Catalogue of High-End Devices for Priority Review (2025 edition) may also be assessed under Announcement No. 63 of 2025, which serves a different purpose.

5. Verification checklist

• □ The free clause for small-enterprise innovative devices still appears in the current catalogue.
• □ Innovation was tested against Article 2(1) of Announcement No. 83: a lawful Chinese invention patent over the core technology.
• □ The review application falls within 5 years of grant publication, with the calculation retained.
• □ The patent is an invention patent, not a utility model or design.
• □ The patent right sits in China, and no foreign patent is the sole basis.
• □ Small-enterprise status was rechecked under the national SME standard using the latest indicators.
• □ Both conditions are met simultaneously, not just one.
• □ The waiver is limited to the registration application; variations, renewals and trial applications are budgeted at standard rates.
• □ For overseas applicants, written confirmation from the receiving department is on file.
• □ Savings are quantified by pathway: domestic Class III CNY 153,600, import Class II CNY 210,900, import Class III CNY 308,800.
• □ Innovation documents, patent certificate and grant publication, and the size statement are archived.
• □ Communication with the reviewing body is scheduled in the plan (Article 22).
• □ Article 120 is cited in the initiation file as the fee basis.

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 acts as the in-China registration agent, coordinates import agent and distributor arrangements, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com