Company: FTII
Filing Date: 2025-02-14
Form Type: S-4
Source: 0001493152-25-006997
Chunk: 389

Company: FutureTech II Acquisition Corp.
Filing Date: 2025-02-14
Form: S-4
Chunk 389
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 refusals                                                                                                    
 or delays in processing submissions or applications for new products or modifications to existing products; |

| ● | refusal                                           
 to grant export or import approvals for products; |

| ● | withdrawing                                                 
 clearances or approvals that have already been granted; and |

| ● | criminal     
 prosecution. |

European Union

We believe that our LBI-201 Aureva TMPulse product candidate would be regulated in the EU as a medical device. We do not currently plan to place our other product candidates on the EU market.

The EU has adopted specific rules regulating, inter alia, the design, manufacture, clinical investigation, conformity assessment, labeling and adverse event reporting for medical devices.

Until May 25, 2021, medical devices were regulated by Council Directive 93/42/EEC and Council Directive 90/385/EEC (the “EU Medical Devices Directives”), which were repealed and replaced by Regulation (EU) No 2017/745 (the “EU Medical Devices Regulation”) on May 26, 2021. If we want to market our medical devices in the EU, they will notably have to comply and be CE marked in accordance with the EU Medical Devices Regulation.

Medical Devices Regulation

The regulatory landscape related to medical devices in the EU recently evolved. The EU Medical Devices Regulation was adopted with the aim of ensuring better protection of public health and patient safety. The EU Medical Devices Regulation establishes a uniform, transparent, predictable and sustainable regulatory framework across the EU for medical devices and ensure a high level of safety and health while supporting innovation. Unlike the EU Medical Devices Directives, the EU Medical Devices Regulation is directly applicable in the EU member states without the need for the member states to implement into national law. This aims at increasing harmonization across the EU.

| 210 |

The EU Medical Devices Regulation became applicable on May 26, 2021. The new Regulation, among other things:

| ● | strengthens                                                                                                                                   
 the rules on placing devices on the market (e.g., reclassification of certain devices and wider scope than the EU Medical Devices Directives) 
 and reinforces surveillance once they are placed on the market;                                                                               |

| ● | establishes                                                                                                                       
 explicit provisions on manufacturers’ responsibilities for the follow-up of the quality, performance and safety of devices placed 
 on the market;                                                                                                                    |

| ● | establishes                                                                           
 explicit provisions on importers’ and distributors’ obligations and responsibilities; |

| ● | imposes                                                                                                                              
 an obligation to identify a person responsible for regulatory compliance