Company: APXIF
Filing Date: 2025-06-13
Form Type: F-4/A
Source: 0001213900-25-054324
Chunk: 385

Company: APx Acquisition Corp. I
Filing Date: 2025-06-13
Form: F-4/A
Chunk 385
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 but generally does not require specific regulatory approval processes as required in the United States and the European Union. The only applicable regulation pertains to laboratories, which might comply with operational standards. In Argentina, LDTs are regulated under general clinical laboratory standards rather than a specific regulatory framework, placing responsibility on laboratories and professionals for quality and reliability. In Mexico, LDTs used solely within laboratory settings are governed by general health regulations without requiring formal approval, while in Paraguay, similar general health regulations apply, with laboratories accountable for quality and compliance. In most countries in Latin America, the ISO 15189:2012 standard is used as a reference for clinical laboratory accreditation; however, compliance with this standard is not mandatory in any of them. To differentiate the value of our LDTs, the objective will be to accredit the tests that we introduce to the market under this standard. While certification is not required in the countries where these products will be marketed, obtaining international accreditation strengthens the validity and quality of their development, even in the absence of a legal framework requiring it. In summary, while LDTs in these countries, as well as in Latin America in general, are not subject to specific regulatory approval processes, laboratories are expected to maintain high standards of practice, ensure the competence of their personnel, and comply with general health regulations. Laboratories within our consortium are required to meet these standards, adhering to rigorous quality practices, maintaining the appropriate legal authorizations, and demonstrating the professional qualifications necessary to deliver reliable LDTs across diverse markets. Our commitment to excellence in LDTs ensures that all our products and services provide the most accurate results, providing our customers with the most precise and relevant information for their healthcare and lifestyle decisions. Telemedicine Services Our telemedicine services will be subject to the regulatory framework within each country where we operate. In Argentina, telemedicine is permitted and regulated under general healthcare standards, and practitioners are required to be licensed and comply with Ministry of Health guidelines to ensure quality and safety in remote consultations. Telemedicine providers in Argentina must adhere to standards of patient confidentiality and data protection, governed by the Personal Data Protection Law, to secure sensitive patient information. In Paraguay, telemedicine practices are less defined by specific regulations, as formal telemedicine standards are still under development. However, the Ministry of Public Health and Social Welfare has endorsed telemedicine as a viable healthcare option, encouraging providers to follow best practices for patient care and data privacy. Our services in Paraguay are aligned with these general standards to ensure quality and compliance with emerging regulatory frameworks