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Health practitioner is a person who has been granted a license to practice medicine by a competent authority of Vietnam. The conditions for eligibility to practice medicine will be different for foreigners or overseas Vietnamese and Vietnamese nationals.

We frequently represent foreigners and overseas Vietnamese doctors, and advise on the conditions and procedures for obtaining Medical Practice License in Vietnam.

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The healthcare system in Vietnam is a mix of public and private service providers, with public hospitals and clinics forming the backbone of the system under the Ministry of Health. These establishments cater to a diverse population with a focus on universal healthcare coverage.

Providing healthcare services is a conditional business activity. One of the conditions is that each healthcare service provider needs to obtain an appropriate license, before commencing any such services. Establishing a health organization involves some complicated areas to cover. We are here for you, whether you need assistance with obtaining the establishment license, supporting your foreign and oversea Vietnamese doctors with medical practice license and immigration documents such as visa/work permit/temporary residence card, registering your medical practitioners, obtaining the medical device license, opening a treatment center, negotiating managed care contractors or something else. You want to make sure that you have an experienced lawyer assisting you with all these matters to ensure that you are starting your business well prepared and protected.

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Acquisitions and sales in the healthcare sector are strategic activities that drive growth, innovation, and market consolidation within the healthcare industry. This process involves the transfer of ownership, assets, or operational control of healthcare entities such as hospitals, clinics, pharmaceutical companies, medical device manufacturers, or wellness centers.

Acquiring or selling a healthcare business is often motivated by various factors. The transactions are heavily influenced by regulatory frameworks, due diligence requirements, and an acute understanding of market dynamics. Key considerations include compliance with health regulations, intellectual property management, patient and data privacy standards, and workforce integration. At TTVN Legal, our team of experienced lawyer assist you with all matters related to deals.

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The regulation of health equipment in Vietnam is governed by a comprehensive legal framework that ensures the safety, quality, and efficacy of medical devices. The Ministry of Health (MOH) is responsible for state management and regulation of health equipment in the country.

We frequently advise and assist our client on the following aspects:

• Registration and Licensing:All medical devices must be registered with the MOH before being marketed or distributed. This process involves submitting technical documentation, clinical evidence, and quality certifications.
• Classification System:Medical devices are categorized based on their level of risk (Class A, B, C, D), with higher classes requiring more stringent compliance measures.
• Import and Distribution:Foreign medical devices must comply with Vietnam’s import regulations, including obtaining import licenses and adhering to labeling requirements in Vietnamese.
• Post-Market Surveillance:Regulations mandate the monitoring of medical devices after they enter the market to ensure continued compliance with safety and performance standards.
• Local Manufacturing Standards:Domestic manufacturers are required to adhere to Good Manufacturing Practices (GMP) and quality assurance systems.

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Intellectual Property (IP) protection plays a crucial role in the healthcare sector. Vietnam has established a comprehensive regulatory framework that aims to foster innovation, ensure market competitiveness, and safeguard the rights of creators and businesses. In healthcare, IP includes patents, trademarks, copyrights, and trade secrets related to pharmaceuticals, medical devices, biotechnology, and health-related digital solutions.

Our lawyer team frequently advises and assists our clients on the following aspects:

• Patent Protection:Pharmaceutical inventions, medical devices, and biotechnological innovations can be patented, granted exclusive rights for up to 20 years. Applicants must demonstrate novelty, inventiveness, and industrial applicability.
• Trademarks:Health companies can register trademarks to protect the branding of their products and services. This ensures consumer trust and market differentiation.
• Data Exclusivity:Vietnam provides data exclusivity protection for clinical trial data submitted for marketing approval, preventing unauthorized use for a specified period.
• Enforcement Mechanisms:The regulatory framework includes provisions for addressing IP infringement through administrative, civil, and criminal actions, to ensure strict IP rights enforcement.

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As a healthcare lawyer, we frequently assist clients in resolving legal disputes that arise within the healthcare industry. Our service involves representing healthcare providers, organizations in court or during settlement negotiations when conflicts or alleged legal violations occur.

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