Form MD108 and Market Surveillance Reporting in Hong Kong, China

1. Key takeaways

Form MD108 is the market surveillance report form designated by the Medical Device Division (MDD). It sits alongside the adverse event reporting forms and belongs to the same post-market surveillance system. The functional division between them is straightforward: adverse event reporting deals with harm or malfunction that has already occurred, while market surveillance reporting deals with compliance and safety signals identified in the market. The ability to identify those signals determines whether a company reports proactively or is found passively, and the two situations carry very different meanings in a regulatory record.

• MD108 is a designated MDD form, not an internal template. Its use is a regulatory act, and the version in circulation must be the current one.
• The two channels are complementary rather than alternative. A single case may require an adverse event report and, separately, a market surveillance view of the same product line.
• The MDD monitors as well as receives. It watches alerts issued by regulators locally, in other jurisdictions and by the World Health Organization, and acts on them.
• Signals reach the regulator from three directions at once: overseas alerts, local complaints and after-sales data. Companies that watch only one of the three will always be late.
• The language arrangement of the forms signals their intended audience, and therefore the channel a company should use for a given audience.

2. Legal basis

The market surveillance channel is established by the designated form, supported by the medical event reporting guideline and the safety alert reporting form, and described in the published overview of the listing process. The government response of January 2024 sets out the monitoring role of the Department of Health. Regulatory information was verified as of 29 October 2026; if an official document has since been updated, the latest published version prevails.

The layout of the legal basis shows a deliberate design. Reporting is not left to a single form. There is a form for events, a form for market surveillance and a separate form for safety alerts, each with its own audience and its own timing. Choosing the wrong form does not remove the information from the system; it simply means the information arrives through a channel that does not fit it, which usually produces a request for clarification and a delay.

3. Expert insights

Insight one: market surveillance runs in both directions, because the MDD is also watching. The government has stated that the Department of Health closely monitors medical device safety alerts issued by the relevant regulatory bodies, including local bodies, bodies in other regions and the World Health Organization, and takes appropriate action according to the circumstances. That action includes contacting local suppliers for follow-up, notifying stakeholders, and publishing summaries of safety alerts and special alerts on its website. A company cannot assume that it alone will report. Where an overseas alert concerns a device listed in Hong Kong, China, the regulator may already know before the local LRP has completed its own assessment.

Insight two: the follow-up action of the MDD follows a fixed pattern. The three actions officially described are contacting the local supplier, notifying stakeholders such as the Hospital Authority, private hospitals and professional medical institutions, and publishing the safety alert. The sequence matters. The first contact is with the supplier, which in practice means the LRP. A single overseas alert can therefore trigger a chain of action in Hong Kong, China, and the LRP will be the first party contacted. The quality of the first response sets the tone for everything that follows: an LRP that can answer with the affected lot numbers, the local distribution and the proposed action within a short time converts a potential enforcement matter into an administrative exchange.

Insight three: the language arrangement of the forms reveals the intended user. The medical device safety alert reporting form is stated to be available in English only. That indicates that it is aimed principally at professional and institutional users, who work in that language and need the technical content without translation delay. MD108, by contrast, is the routine channel for local market surveillance. A company deciding which channel to use should therefore start from the audience and the purpose, not from which form happens to be saved on a shared drive.

Insight four: signal identification can be institutionalised. Bringing three information sources onto a single dashboard — monitoring of overseas regulatory announcements, trends in local complaints, and after-sales repair data — is a workable way to identify signals (practical estimate). The value lies less in the dashboard than in the review rhythm attached to it. A monthly review with a named owner and a recorded conclusion turns scattered observations into a defensible assessment trail; without that rhythm, the same data sits in three systems and produces no decision.

Insight five: the boundary between the two channels must be written down. The most common failure is not the absence of a report but the wrong report. A field correction discussed as a complaint, or a market withdrawal handled as a customer service matter, produces a record that looks complete internally and is visibly incomplete externally. The test is whether the company can state, before an event occurs, which type of occurrence goes to which form. Once that rule exists, the decision at the moment of the event becomes mechanical rather than discretionary.

4. Practical recommendations

• Establish an overseas alert monitoring mechanism. Subscribe to the regulatory announcements of the principal reference jurisdictions and assign a named person to consolidate them weekly.
• Bring after-sales data into the signal sources. Repair rates, return and exchange rates and repeat complaints should be analysed at fixed intervals rather than reviewed only when a customer complains.
• Define the trigger for completing MD108. State in the quality system which situations require MD108, so that it is not confused with adverse event reporting.
• Pre-set the response to an MDD contact. Decide who answers, within what time, and how the answer is confirmed in writing, and record that in the procedure.
• Keep one signal file. Log every signal, its source, its assessment and its outcome in a single register so that a trend can be shown across channels.

5. Verification checklist

• □ The current version of Form MD108 has been obtained
• □ The trigger for completing MD108 is defined in the quality system
• □ A periodic mechanism for monitoring overseas regulatory announcements is in place
• □ After-sales repair and complaint data are included in signal analysis
• □ The response procedure for an MDD contact names an owner and a time limit
• □ The division between adverse event reporting and market surveillance reporting is documented
• □ The safety alert reporting form has been reviewed for its professional audience
• □ A single signal register records source, assessment and outcome

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