Entering the health supplement market in East Asia and Southeast Asia/ASEAN presents a lucrative opportunity for businesses. However, the regulatory landscape can be complex and daunting. This is where top-tier regulatory consulting firms, such as MyAssociates, come into play.

Health supplement registration across East Asia and Southeast Asia/ASEAN requires a deep understanding of diverse regulatory frameworks. From Singapore’s stringent Health Sciences Authority (HSA) standards to Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) guidelines, and China’s National Medical Products Administration (NMPA) requirements, compliance is key to successful market entry.

Our consulting services ensure your health supplement products meet all regional and national regulations, providing peace of mind and a clear path to market. We assist with product classification, formulation review, claims substantiation, and preparation of comprehensive dossiers for registration. Our strategic insights and robust network in East Asia and ASEAN streamline the registration process, minimizing delays and maximizing efficiency.

Unlock your business’s full potential with our expert guidance. Contact us today to learn how we can help you succeed in the dynamic health supplement markets of East Asia and ASEAN.

Health Supplement Regulatory Services

Regulatory Compliance and Advisory


Guidance on local regulations and compliance requirements. Interpretation of cosmetic product regulations and standards. Advisory on ingredient regulations and prohibited substances.

Market Entry Strategy

Market research and analysis to identify opportunities and trends. Tailored entry strategies to capture local market dynamics.

Product Registration and Notification

Assistance with product registration and notification processes. Preparation and submission of necessary documentation to regulatory authorities. Handling of regulatory queries and follow-ups.

Safety Compliance

Formulation and ingredient review. Ensuring ingredients meet the safety requirement in the target countries.

Labelling and Claim Compliance

Review and development of compliant product labels. Ensuring labels meet local language requirements and include all necessary information. Verification of claims and compliance with advertising regulations.

Safety and Quality Testing

Coordination of product safety testing and toxicological assessments. Quality control testing to ensure compliance with local standards. Microbiological and stability testing.

Local Representative/ Responsible Person (RP)/License Holding Provision of cosmetic notification holding services. Acting as your local responsible person/regulatory representative.

Post-Market Surveillance and Lifecycle Management

Support for post-marketing activities. Lifecycle management of cosmetic notifications, including variations, updates, and renewals to maintain compliance throughout the product lifecycle.

Regulatory Authority Liaison
Acting as a liaison with local regulatory authorities. Representation in regulatory meetings and discussions. Handling of regulatory inspections and audits.

Recall Assistance and Crisis Management

Advisory and support in case of regulatory enforcement actions. Management of product recalls and market withdrawals. Development of corrective action plans and communication strategies.

Document Translation and Localization
Translation of regulatory documents, labels, and marketing materials. Localization of product information to meet cultural and regulatory requirements.

Training and Workshops Conducting training sessions on regulatory compliance and best practices. Workshops on specific regulatory topics and new market entry. Customized training programs for regulatory affairs teams.