Post-Market Duties of the Local Responsible Person in Hong Kong, China

1. Key takeaways

The official overview of the listing process compresses the post-market duties of the Local Responsible Person (LRP) into four items: handling complaints, reporting adverse events, managing product recalls and keeping records for inspection by the Medical Device Division. The party carrying all four is the LRP, not the overseas manufacturer. This is the key difference between MDACS and many other markets: an overseas manufacturer cannot be released from the obligation by arguing that it is not present locally. The only available route is to make the execution chain work through contracts and procedures.

• The four duties are not four parallel obligations of equal weight. Record keeping is the evidential base for the other three, because each of them produces records that must be produced on demand.
• The duty holder is the LRP. Delegation of the work is possible; delegation of the responsibility is not.
• Government statements extend the requirement beyond the LRP to all traders — the LRP, the local manufacturer, the importer and the distributor.
• Records are examined during site inspections, not only on paper. Guidance GN-08 requires records and written procedures to be produced and permits inspection of business premises and related storage or transport facilities.
• Complaint data is itself a compliance asset: it shows whether the process is running, and it is the raw material for signal detection.

2. Legal basis

The four duties are set out in the published overview of the listing process and are reinforced by the code of practice for LRPs, the medical event reporting guideline, the guideline for local manufacturers and a government reply to the Legislative Council. The table records the instruments, their identifiers, publication status and the provisions engaged. Regulatory information was verified as of 29 October 2026; if an official document has been updated since that date, the latest published version prevails.

The instruments operate at different levels: the overview describes the duties in operational terms, COP-01 sets the standard of conduct expected of the LRP, GN-03 supplies the reporting mechanism, and GN-08 addresses the local manufacturer. Reading only one of them produces an incomplete picture of what an inspection will look for.

3. Expert insights

Insight one: among the four duties, record keeping is the evidential foundation for the rest. Complaint handling, adverse event reporting and recall management each generate records. If the record system is weak, the other three duties cannot be shown to have been performed when an inspection takes place. Record keeping is not a fourth duty standing beside the others; it is the support under the first three. A company that treats it as an administrative afterthought will find that a well-run complaint process leaves no trace, and an untraceable process is, for regulatory purposes, indistinguishable from one that never ran.

Insight two: the government reply extends the obligation to all traders. In its reply to a Legislative Council question on 9 July 2025, the government stated that traders, including the LRP, local manufacturer, importer and distributor, must meet the relevant requirements. Those requirements include holding a valid business registration certificate, maintaining a quality management system for the supply of medical devices, and complying with controls after a product is placed on the market, so that they bear responsibility for the safety of medical devices. The practical effect is that the post-market question cannot be confined to the LRP function. An importer that holds stock and a distributor that places a device with a hospital are inside the same accountability perimeter.

Insight three: site inspections examine these records. Paragraph 4.10 of GN-08 requires the provision of records and written procedures, and permits inspection of business premises and the related storage or transport facilities. The point is not only that the records must exist, but that they must be retrievable on site. A record stored in a system that requires a foreign administrator to grant access, or held only in a manufacturer’s global database without a local extract, will not satisfy the practical test of an inspection conducted at the premises.

Insight four: complaint data is itself a compliance asset. The government has stated that since 2019 the Department of Health had received 5 complaints concerning medical devices listed under MDACS, all of them relating to product quality, and that after investigation there was no evidence showing a product quality problem. The figure should be read carefully. A low number of complaints does not mean that no complaints exist; it means that few have reached the regulator. The handling process remains a required capability regardless of volume, and the record of how each complaint was resolved is what demonstrates that capability when the question is asked.

Insight five: the four duties share one information chain. A complaint can become an adverse event report; an adverse event can become a recall; a recall generates records that feed back into complaint trends. Where the four are managed by four separate procedures with no shared identifier, the same case appears four times under four numbers and no single view of the product exists. Where they share one case number and one owner, an inspection can follow the case from the first telephone call to the final closure letter. The design choice is made once, in the quality system, and it determines the cost of every future inspection.

4. Practical recommendations

• Create one procedure document for each of the four duties: complaint handling, adverse event reporting, recall management, and record retention and retrieval. Each should name its owner, its trigger and its output record.
• Set response time limits. State in each procedure the internal response time and the external reporting time for each category of matter, and assign a named person rather than a department.
• Centralise the archive. Store and number the four record types under one scheme so that any case can be produced within a short time during an inspection.
• Run an annual drill. Exercise the recall procedure once a year to test the notification chain and the completeness of the records, and record the result as evidence of a functioning system.
• Put the information chain into the contract. Agree how and how quickly the manufacturer informs the LRP, and how the LRP’s records are made available locally.

5. Verification checklist

• □ Each of the four post-market duties has its own procedure document
• □ Response time limits and named owners are set for each category of matter
• □ Records are centrally archived and can be retrieved quickly during an inspection
• □ The recall procedure has been exercised within the past year
• □ The LRP and manufacturer notification mechanism is written into the contract
• □ The business registration certificate and quality management system remain valid
• □ Importer and distributor obligations are reflected in the supply agreements
• □ Complaint records show the resolution, not only the receipt

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for Hong Kong, China. Our team manages adverse incident reporting and recall coordination with the Department of Health, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com