- within International Law topic(s)
Recent regulatory developments in the medical devices sector point to a shift from procedural compliance toward enforcement-driven market discipline, coupled with a gradual restructuring of technical service governance.
A major inflection point in this trajectory was the entry into force of Law No. 7557 in July 2025, which introduced Additional Article 20 to the Basic Law on Health Services. This provision significantly expanded the administrative sanctions framework applicable to medical devices, particularly targeting counterfeit products, unauthorised sales channels, and unlicensed technical service activities.
By introducing high-value administrative fines and extending liability beyond formally authorised actors, the legislator effectively closed a long-standing enforcement gap. Under the new framework, both authorised and unauthorised persons or entities may be held accountable for placing counterfeit devices on the market, engaging in sales or promotional activities outside permitted channels, or providing technical services without proper authorisation. The inclusion of recidivism-based penalty escalation further signals an intention to enhance deterrence and discourage systemic non-compliance.
From a governance perspective, this development marks a transition toward a more robust market surveillance model, where financial sanctions are positioned as a central tool for safeguarding patient safety, protecting intellectual property, and ensuring fair competition.
On the other hand, the Regulation on Technical Services for Medical Devices Used in Healthcare Services introduced a comprehensive framework governing the authorisation, qualifications, training, and supervision of technical service providers. While the regulation itself entered into force its upon publication, the deadline for full compliance with its technical service requirements has been extended. Through an amendment to the transitional provisions, the deadline for ensuring conformity of technical service activities with the regulation has been postponed from 1 January 2026 to 1 July 2027.
This extension will allow the structural and operational adjustments required across the sector, particularly in relation to personnel qualifications and certification processes.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
[View Source]
