Knowledge base
Improving prevention, early detection and treatment of cancer
Allows recognition-based registration and certified import of new oncology medicines and medical devices listed by a Council. Amends the medical device registration regulation (Resolution No. 738), including removal of the ISO 13485-based manufacturing inspection requirement.
- Act type
- Presidential Resolution
- No.
- PP-238
- Adopted
- 24 June 2026
- Section
- Registration and dossier
Official text
Improving prevention, early detection and treatment of cancer
Presidential Resolution · No. PP-238 · 24 June 2026
Related documents
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- Order of the Minister of Health · No. 2 · 14 April 2026Checked against the official sourceProcedure for inspecting the manufacturing conditions of medical devices during state registrationMedical devices and equipmentMedicines
- Cabinet of Ministers Resolution · No. 738 · 24 November 2025Checked against the official sourceState-registration procedures for medicines and medical devicesMedicinesMedical devices and equipment
- Presidential Decree · No. UP-137 · 19 August 2025Checked against the official sourceAdditional measures regulating the circulation of medicines and medical devicesMedicinesMedical devices and equipment