Hong Kong Clarifies Injectable Products Are Regulated as Pharmaceutical Products Under Cap. 138

On April 23, 2026, Hong Kong’s Pharmacy and Poisons (Registration of Pharmaceutical Products and Substances) Committee formally endorsed an update to the Guidance Notes on Classification of Products as “Pharmaceutical Products” under the Pharmacy and Poisons Ordinance (Cap. 138).

While framed as a clarification rather than a change in law, this update has immediate regulatory consequences for companies marketing injectable, borderline, and medical aesthetics products in Hong Kong.

The key message is clear: “Products intended for human parenteral injection are, in general, regarded as pharmaceutical products and are subject to regulation under the Pharmacy and Poisons Ordinance.”

For companies involved in distribution planning or import preparation, this means a prompt review of affected products is essential to ensure compliance and avoid potential regulatory or customs issues.

Snapshot: What the Clarification Means

The clarification strengthens Hong Kong’s regulatory position on injectable product classification. It is especially relevant for overseas manufacturers relying on medical device classifications from other jurisdictions.

• Injectable products are now explicitly regarded as pharmaceutical products by default in Hong Kong
• Overseas medical device classifications, including those from China or the EU, are not automatically recognized
• Many medical aesthetics injectables may fall outside Hong Kong’s medical device regulatory scope.
• Borderline injectables face higher risk of customs delays or non-clearance
• Some products may encounter a regulatory gap with no straightforward pathway to market

In short, injectable products in Hong Kong are now under heightened regulatory scrutiny, and companies should review their portfolios immediately

Background and Guidance: How Hong Kong Classifies Injectable Products

Under the Pharmacy and Poisons Ordinance (Cap. 138), pharmaceutical products must be registered with the Pharmacy and Poisons Board before they can be sold, supplied, or distributed in Hong Kong. Additionally, manufacturing, importation, wholesaling, and retailing activities are subject to licensing requirements.

The April 2026 update clarifies how injectable products are classified, especially those previously in regulatory grey areas. The Committee emphasized that parenteral products are inherently high risk, as they:

• Enter systemic circulation or human tissue directly
• Bypass the body’s natural defence mechanisms
• Pose immediate and potentially life‑threatening risks if sterility, quality, or handling is compromised

The updated Guidance Notes specify that products intended for human parenteral injection are generally classified as pharmaceutical products, unless they clearly fall into another regulatory category, such as medical devices, or are assessed individually on a case-by-case basis.

Key milestones include:

• April 23, 2026 — Pharmacy and Poisons Board endorses the updated “Guidance Notes on Classification of Products as Pharmaceutical Products.”
• April 23, 2026 — Letter to trade issued, signaling immediate effect.

This clarification aligns Hong Kong with regulatory practices in Mainland China, Europe, and the UK, where injectable products are typically subject to strict medicines or device frameworks.

Implications for Manufacturers and Importers

The clarification affects classification, registration, and customs compliance. Companies must reconsider assumptions based on prior practice or foreign approvals

Assume Default Pharmaceutical Status for Injectables

Following the April 2026 update, products intended for injection should be assumed to be pharmaceutical products in Hong Kong unless convincingly justified otherwise. This reflects a clearer and more conservative regulatory interpretation rather than a change to the statutory definition.

Overseas Medical Device Classification Is Not Automatically Accepted

Even if a product is approved as a medical device in China or the EU, that classification does not automatically apply in Hong Kong. Product classification is determined independently based on Cap. 138, local risk considerations, and regulatory interpretation.

Medical Aesthetics Injectables Face Particular Uncertainty

Injectable products with purely cosmetic or aesthetic indications, such as wrinkle correction or anti-aging, may face particular uncertainty in Hong Kong:

• They may not qualify as medical devices due to lack of recognized medical purpose
• They may struggle to meet pharmaceutical registration requirements without a medical indication

In short, injectable aesthetics products may be too high risk to be treated as ordinary cosmetic products, but they may not fit easily into the pharmaceutical or medical device pathway.

Recent cases involving Mainland China–approved injectable biomaterial products illustrate this challenge in practice. In these cases, products were approved overseas as innovative medical devices for injectable aesthetic use, but in Hong Kong:

• Medical device listing was not accepted due to cosmetic‑only indications, and
• Pharmaceutical classification was triggered by the injectable route and active biological components

Following the April 2026 clarification, reliance on informal correspondence or prior device‑listing attempts is increasingly risky, and such products may face customs detention or non‑clearance if classification issues are unresolved.

Product Registration Remains Separate from Clinical Use

Companies should distinguish product-level regulatory requirements from clinical use by medical practitioners. This distinction is important for medical beauty and aesthetics products.

In Hong Kong, injection‑based aesthetic procedures must be performed by registered medical practitioners, and registered pharmaceutical products may, in principle, be used off‑label by doctors in medical beauty settings. This explains how certain registered medicines continue to be used cosmetically in practice.

However, this does not reduce the product‑level regulatory requirements. Injectable products must still be lawfully classified and registered before importation or supply. Where products cannot be accepted as medical devices and cannot meet pharmaceutical registration requirements, they face a real risk of customs detention, enforcement action, or market exclusion, regardless of intended clinical use.

Early classification strategy is therefore critical for Hong Kong market access.

Next Steps for Companies

Foreign manufacturers, overseas applicants, and Hong Kong importers should reassess affected products early. The main priority is to confirm whether a viable regulatory pathway exists before shipment or commercial launch.

Reassess Classification Strategy Early

Companies developing or distributing injectable products should reassess their Hong Kong classification strategy before relying on overseas device precedent or historical practice.

This is particularly important for products approved as medical devices overseas but administered by injection in Hong Kong.

Expect Increased Customs Scrutiny

Borderline or ambiguously classified injectable products may face heightened customs scrutiny following the formal clarification.

Importers should expect greater risk of customs detention, import delays, or non-clearance where classification has not been resolved before shipment.

Prepare for Potential Regulatory Gaps

Some injectable products may not clearly qualify as either medical devices or pharmaceuticals in Hong Kong.

This creates regulatory and commercial uncertainty. Companies should identify these risks early and assess whether evidence, indication wording, product composition, or market positioning affects the available pathway.

Assess Whether Pharmaceutical Registration Is Unavoidable

Where Hong Kong requires pharmaceutical registration despite overseas device status, companies may need to restart their regulatory strategy.

This may include identifying recognized reference countries, preparing pharmaceutical registration documentation, and obtaining a Certificate of Pharmaceutical Product to support registration.

Why the Clarification Matters for Hong Kong Market Access

The April 2026 update significantly reduces ambiguity around injectable product classification in Hong Kong, while simultaneously raising the regulatory bar for market entry. Assumptions based on overseas medical device classifications are increasingly risky, particularly for medical aesthetics and borderline injectables.

For manufacturers and distributors, the challenge now lies in navigating classification risk, registration feasibility, and market continuity in an environment where injectable products sit firmly under heightened regulatory scrutiny.

Cisema supports companies in assessing classification pathways, managing regulatory risk for injectable and borderline products, and developing compliant market entry and registration strategies for Hong Kong.

Contact Cisema to discuss how this update may affect your injectable or medical aesthetics products.

About the Author: Jacky Li

Jacky Li is a Senior Manager at Cisema, based in Hong Kong and Taiwan. He has over a decade of experience in regulatory intelligence and market access, and serves as the lead supporting clients across Hong Kong, Mainland China (including the Greater Bay Area), and Taiwan, with a strong focus on pharmaceutical and medical device regulatory projects.

Further Information

Explore Cisema’s Hong Kong advisory services:

• Hong Kong Drug Registration Advisory Services
• Hong Kong Medical Device Listing Advisory Services

References

Drug Office, Department of Health – “Letter to Trade: Update of ‘Guidance Notes on Classification of Products as Pharmaceutical Product…, April 23, 2026

Drug Office – “Guidance Notes on Classification of Products as Pharmaceutical Products”

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