Registrant and Filer System: Responsible Parties and the Duty List

1. Key takeaways

The Regulations establish a responsibility system, not a registration formality. Once registrant or filer status is obtained, five duties arise under Article 20, paragraph 1.

Three conclusions follow.

• The certificate holder is responsible. Whether or not it manufactures, the registrant answers for safety and effectiveness across development, production, distribution and use (Article 13).
• Overseas registrants have an assistance layer. The appointed Chinese enterprise legal person assists with the Article 20(1) duties and with implementing the corresponding legal liability (Article 20(2); Order No. 47, Article 14(2)).
• Class does not remove duties, only change their intensity. Class I is filed and Classes II and III registered (Article 13), yet a filer carries the same lifecycle responsibility.

The GRZAN view. The usual failure is duties that exist before organisational capability does. Three of the five, post-market study, re-evaluation, and traceability and recall, need cross-departmental processes a registration team cannot close alone. Assign each duty to a post.

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 13 requires the registrant or filer to bear responsibility for safety and effectiveness. Article 20(1) lists the five duties and Article 20(2) makes the appointed Chinese legal person an assistant. Article 21 requires variations for substantial changes. Article 22(1) sets 5-year validity with renewal 6 months ahead; Article 32 sets a 20-working-day licence decision valid 5 years; Article 34 allows self or contract manufacture, with the manufacturer responsible for its production activities; Article 85 penalises false filing information.

Departmental rules. SAMR Order No. 47, promulgated 26 August 2021, effective 1 October 2021: Article 5 gives the NMPA review center technical review of domestic Class III and import Class II and III applications; Article 6 gives provinces domestic Class II review and system inspection; Article 14 requires a capable applicant and a Chinese agent; Article 15 requires a suitable quality system; Article 79 requires name and address changes to be filed within 30 days; Article 107 sets a CNY 10,000 to CNY 30,000 fine for late filing.

SAMR Order No. 53, promulgated 10 March 2022, effective 1 May 2022, requires licences for Classes II and III and filing for Class I (Article 4), a 20-working-day decision with the certificate within 10 working days (Article 13), and inspection within 3 months of Class I filing (Article 22). Former Order No. 6, promulgated 30 July 2014, effective 1 October 2014, requires the agent details in instructions (Article 10(2)) and labels (Article 13(2)) and forbids unauthorised changes to reviewed instructions (Article 16).

Normative documents. The Good Manufacturing Practice, NMPA Announcement No. 107 of 2025, issued 4 November 2025, effective 1 November 2026, has 15 chapters and 132 articles, adds quality assurance, verification and confirmation, and contract manufacturing and outsourcing, and repeals Announcement No. 64 of 2014. Notice No. 50 of 2022, published 29 September 2022, sets four inspection outcomes. Article 15 of the 2019 UDI System Rules requires upload before sale, and Announcement No. 46 of 2025, issued 28 April 2025 and effective 1 October 2025, adds online sales duties.

Practical estimate. No unified official template exists for the working documents behind the duties, such as post-market study plans, re-evaluation procedures and recall drill records; confirm the expected format with the provincial administration before an inspection.

3. Expert insights

Responsibility starts before certification. The quality system duty begins in development, while post-market duties begin at launch and traceability runs to withdrawal. The registration system inspection exists because development-stage records must already exist, and those cannot be recreated later.

Registrant and manufacturer are different roles. The registrant owns design, technical requirements, clinical conclusions and recall decisions, while the contract manufacturer answers for its production activities. A contract cannot shift design defects, inadequate clinical evaluation or a missing post-market study. This explains the new chapter on contract manufacturing: the longer the chain, the heavier the burden of proving control.

Overseas registrants carry an extra link. The agent assists with the five duties and with local implementation of liability, which is not a general commission. Authorisations limited to filing leave no local capacity when a recall arises. The agent details are a filing item under Article 79, with a 30-day window.

Filers carry lighter controls, not immunity. Filing is complete on submission, with no registration system inspection or five-year renewal, but the lifecycle responsibility is identical in source with fewer tools and later intervention. False filing information is handled under Article 85.

Evidence determines the result. Each duty maps to a document set, from the quality manual to recall drill records. Drill records are the most neglected, since a procedure never tested suggests a system that is not operating, and Article 20(1) demands effective operation rather than paper.

Transferring a certificate transfers the duties. The receiver must be an enterprise or research institution able to bear liability, hold a suitable quality system, and inherit the historical post-market study, adverse event and risk evaluation records without a gap; a break undermines later re-evaluation.

4. Practical recommendations

• Assign each duty to a post, naming the accountable role and record custodian.
• Start the quality system during development; design planning, inputs, outputs, transfer, verification and validation records must be complete.
• List the agent duties item by item. Cover adverse event receipt and reporting, recall execution, UDI maintenance, regulatory communication and post-market document transfer.
• Track agent changes on a 30-day log; a name or address change is a filing item under Article 79.
• Run and record a recall drill. A procedure plus a drill record shows execution rather than a document on a shelf.
• Upload UDI data before first sale. Article 15 of the UDI rules makes this part of the release process, controlled at release.
• Fix three non-transferable duties in the contract: design, clinical evaluation, and post-market and recall decisions stay with the registrant.
• Convert system documents before 1 November 2026; the new practice has 15 chapters and 132 articles.

5. Verification checklist

• □ Registrant or filer status meets Article 14(1).
• □ Each of the five duties assigned to a post and a record custodian.
• □ Quality system operating from development, with complete design records.
• □ Post-market study plan issued, with periodic reports and risk file updates.
• □ Adverse event procedure and periodic risk reports traceable.
• □ Traceability and recall systems in place, with a drill record.
• □ Responsibility split for self or contract manufacture written into the agreement.
• □ Contract manufacturer qualification and supervision mechanism established.
• □ Chinese agent appointed, with duties listed in the authorisation.
• □ Agent name and address filed, with a 30-day change log.
• □ Import instructions and labels state the agent details under Order No. 6.
• □ UDI data uploaded before first sale under Article 15.
• □ Certificate renewal tracked at 5 years, filed 6 months ahead.
• □ Production licence renewal tracked separately at 90 to 30 working days before expiry.

Verified as at 29 October 2026 against NMPA, SAMR and State Council publications.

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