Sanctions
- In accordance with Article 56(1)(1) of Law No. 12/2025 “Supervision and administration regime for medical devices”, supplying medical devices that have not been registered or filed as prescribed by law, or medical devices whose registration or filing has been suspended, revoked, cancelled or invalidated, shall be subject to a fine of MOP10,000 to MOP700,000 in the case of registration, and a fine of MOP1,000 to MOP20,000 in the case of filing.
- In accordance with Article 56(1)(2) of Law No. 12/2025 “Supervision and administration regime for medical devices”, conducting clinical trials of medical devices without prior authorization from the Pharmaceutical Administration Bureau shall be subject to a fine of MOP20,000 to MOP200,000.
- In accordance with Article 56(1)(9) of Law No. 12/2025 “Supervision and administration regime for medical devices”, deleting or altering the batch number or serial number, or the manufacturing date, use-by date or expiry date on the original label or instructions for use of a medical device shall be subject to a fine of MOP10,000 to MOP200,000.
- In accordance with Article 56(2)(1) of Law No. 12/2025 “Supervision and administration regime for medical devices”, failure to comply with an order issued by the Pharmaceutical Administration Bureau to delete, add or change information on the label or instructions for use of a registered or filed medical device, for the purpose of protecting public health and ensuring the rational use of medical devices and avoiding harm to public health, shall be subject to a fine of MOP10,000 to MOP100,000.
- In accordance with Article 56(2)(2) of Law No. 12/2025 “Supervision and administration regime for medical devices”, violation of the obligations of registration holders and filing holders set out in Article 16 of the same Law shall be subject to a fine of MOP10,000 to MOP100,000.
- In accordance with Article 56(2)(3) of Law No. 12/2025 “Supervision and administration regime for medical devices”, failure to notify the Pharmaceutical Administration Bureau in writing 20 working days in advance of changes to the registered information of a medical device, or five working days in advance of changes to the filing, shall be subject to a fine of MOP5,000 to MOP50,000.
- In accordance with Article 56(2)(4) of Law No. 12/2025 “Supervision and administration regime for medical devices”, changing registered information without prior authorization from the Pharmaceutical Administration Bureau shall be subject to a fine of MOP10,000 to MOP100,000.