Company: NIVFW
Filing Date: 2025-09-18
Form Type: F-1
Source: 0001213900-25-088927
Chunk: 82

Company: NewGenIvf Group Ltd
Filing Date: 2025-09-18
Form: F-1
Chunk 82
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 assumptions underlying the market data is later found to be incorrect, actual
results may differ from the projections based on these assumptions.

Risks Related to Government Regulation

NewGenIvf operates in a highly regulated industry and must comply with a significant number of complex and evolving requirements. Any lack of requisite approvals, licenses, or permits applicable to NewGenIvf’s business may have a material and adverse impact on NewGenIvf’s business, financial condition, and results of operations.

The operations of NewGenIvf
are subject to various laws, rules and regulations at the national, regional and local levels in Thailand, Cambodia, Kyrgyzstan, Hong
Kong, United Arab Emirates, United States of America and other applicable jurisdictions. Such laws and regulations mainly relate to (i) the
licensing of local and foreign medical professionals, nursing professionals, medical technology professionals, pharmaceutical professions
and other applicable licensing; (ii) the licensing, registration, and accreditation of medical facilities, laboratories, including
but not limited to the licensing, registration, and accreditation of persons performing related activities; (iii) the privacy and
security of confidential patient medical records; (iv) the corporate practice of medicine; (v) healthcare fraud and abuse laws;
(vi) the donation and transplantation of human cells, tissues and organs; (vii) potential prohibition on surrogacy or providing
intermediary assistance in surrogacy; and (viii) licensing and approval of the accommodation provided as parts of the services.

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NewGenIvf has attempted
to structure its operations to comply with laws, regulations and other requirements applicable to it directly and to its clients and
vendors, but there can be no assurance that its operations will not be challenged or impacted by regulatory authorities or
enforcement initiatives, or that the relevant authorities in each jurisdiction could impose higher standards or requirements, which
NewGenIvf may have difficulty to adhere to, e.g. Medical Facilities Act B.E. 2541 (1998) and Protection of a Child Born by
Medically Assisted Reproductive Technology Act B.E. 2558 (2015) for Thailand jurisdiction, Law on Reproduction Rights and on
Guarantees of Their Realization of July 4, 2015 No. 148, Law on status of medical worker of May 28, 2013 No. 81 and Temporary
Regulation on Procedure of Licensing Private Medical Activity approved by the resolution of government of