Company: APXIF
Filing Date: 2025-03-31
Form Type: F-4/A
Source: 0001213900-25-026339
Chunk: 371

Company: APx Acquisition Corp. I
Filing Date: 2025-03-31
Form: F-4/A
Chunk 371
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 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. 190 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. In Mexico, telemedicine is permitted but not governed by specific regulations; services must comply with general healthcare laws, including patient rights and data protection. We strictly adhere to these regulations, ensuring that licensed healthcare providers conduct all telemedicine consultations in compliance with Mexico’s Federal Law on the Protection of Personal Data Held by Private Parties. All our medical geneticists and nut