Criminal and Administrative Liability under the Penalty Regime

1. Key takeaways

Chapter V of Law No. 12/2025, the penalty regime, establishes a two-tier system of criminal and administrative liability. The criminal tier centres on Article 51, the offence relating to counterfeit medical devices: importing, exporting or supplying a counterfeit medical device, or manufacturing, transporting, storing or displaying one with a view to its import, export or supply, thereby endangering the life of another person or creating a serious danger to another person’s physical integrity, is recommended to be punishable by 1 to 8 years of imprisonment. Companion provisions are Article 52 (offence of disobedience), Article 53 (criminal liability of legal persons and equivalent entities), Article 54 (principal penalties) and Article 55 (supplementary penalties). The administrative tier runs from Article 56 onwards, covering administrative offences, supplementary sanctions, recidivism, admonition, administrative liability of legal persons, payment of fines and compulsory collection, and the destination of fine proceeds.

2. Legal basis

The instruments and provisions constituting the criminal and administrative liability framework are listed below.

3. Expert insights

Insight one: the reach of the counterfeit device offence covers the entire supply chain. The provision lists importing, exporting and supplying, and manufacturing, transporting, storing or displaying for the purpose of import, export or supply. This means that not only the counterfeiter but also transport, warehousing and display operators may fall within the scope of the provision where they act knowingly. Logistics and warehousing service providers need to reassess their own compliance exposure.

Insight two: this is an offence of endangerment, not of actual harm, so the threshold for criminal liability is low. The constituent elements are that the conduct endangers the life of another person or creates a serious danger to another person’s physical integrity — no actual damage needs to have occurred. Creating the danger is enough. This logic differs entirely from the civil logic of product liability, and companies should not reassure themselves during risk assessment with the thought that no accident has happened yet.

Insight three: corporate criminal liability is the real pain point for companies. Article 53 provides for the criminal liability of legal persons and equivalent entities, Article 54 for principal penalties and Article 55 for supplementary penalties. A company is not exonerated on the ground that the decision was made by one individual; conversely, Article 64 addresses employment relations and the allocation of responsibility for employee conduct. This has a direct impact on distributors and manufacturers with a legal presence in Macao.

Insight four: the administrative liability framework is graduated and has a lenient exit. Article 59 establishes a system of admonition — for certain minor administrative offences the regulator may first admonish rather than impose a fine directly. This is a rare element of flexibility in the regime, and companies should make good use of it: self-reporting and prompt correction after discovering a violation help to obtain admonition instead of a sanction. Article 58 on recidivism, by contrast, aggravates.

Insight five: administrative offences and refusal of registration operate independently. Article 16 of the Implementation Rules lists providing false declarations or false information, or using other unlawful means, as a statutory ground for refusing registration. This means a single false submission produces two consequences at once: the application is refused, and criminal or administrative liability may be triggered. The authenticity of submission materials is an absolute red line under the Macao regime.

4. Practical recommendations

• Make material authenticity an inviolable red line: any form of embellishment, exaggeration or signing on another’s behalf may trigger Article 51 or Article 16.
• Run a compliance review across the whole supply chain: transport, warehousing and display service providers are equally within scope.
• Build criminal risk protection at the corporate level: ensure decision-making is documented and an internal reporting mechanism exists.
• Report violations proactively when discovered: seek admonition under Article 59 rather than a fine.
• Watch the Article 43 prohibition-on-supply list: build a compliance verification step before sale.
• Avoid recidivism: repeated occurrence of the same problem triggers aggravation under Article 58.

5. Verification checklist

• □ Management has been briefed on the constituent elements of the Article 51 offence and the 1 to 8 year imprisonment range
• □ Compliance review of each supply-chain link (import, export, transport, storage, display) is complete
• □ Corporate criminal liability risk (Articles 53–55) has been assessed at the corporate governance level
• □ Types of administrative offence (Article 56) and supplementary sanctions (Article 57) have been identified
• □ The possible application of admonition (Article 59) and the path to obtaining it are understood
• □ Aggravation risk from recidivism (Article 58) is tracked within rectification follow-up
• □ A verification mechanism for the authenticity of submission materials is in place
• □ Article 43 prohibition-on-supply situations are checked within the sales process

Legal information verified as of October 29, 2026. The laws, guidelines and effective dates described in this article are limited to the published content of the official sources listed under Legal basis as of that date; where official documents are updated, the most recently published version prevails.

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