Regulatory Affairs Services in Singapore

We offer an end-to-end regulatory affairs solutions in Singapore to support healthcare product registration and approvals with a clear, strategic approach.

Consulting Services For Regulatory Affairs In Singapore

Singapore has emerged as a key regulatory gateway for healthcare companies targeting Southeast Asia. Singapore’s healthcare market is robust and growing tremendously with a projected revenue of US$13.03 billion by 2029, an annual growth rate of 7.10% from 2025 to 2029.

The Health Sciences Authority (HSA), under the Ministry of Health, plays a central role to regulate therapeutic products, medical devices, health products, and cosmetics. For foreign manufacturers, getting a product approval is more than just submitting paperwork as it requires a local partner and an understanding of the process. Working with the best regulatory affairs company like Artixio can help you navigate the process with confidence.

Regulatory Authorities in Singapore

Authority	Scope
Health Sciences Authority (HSA)	Responsible for evaluation and registration of drugs, devices, biologics, and cosmetics.
Ministry of Health (MoH)	Responsible for healthcare policies, licensing of healthcare institutions and professionals.

Regulatory Affairs Process In Singapore

The product registration regulatory process in Singapore involves the following six key stages. While timelines and formats vary across product categories, the below reflects the general regulatory lifecycle:

Step 1 - Product Classification

Before submission, the applicant must identify the correct product category to determine the documentation required.

Incorrect classification may lead to delays or outright rejection.

Step 2 - Appoint a Local Authorized Representative (LAR)

Foreign companies require a designated Singapore-based Local Authorized Representative (LAR) to manage the product application with HSA. They also hold the marketing authorization and must have a valid import license, where applicable.

Step 3 - Dossier Preparation

Depending on product type, the following dossier formats must be followed:

Documents must be submitted in English.

Step 4 - Application Submission & Evaluation

Submissions are made via HSA’s PRISM portal. Evaluation timelines vary by the regulatory pathway:

Evaluation Route	Eligibility	Timeline
Full Evaluation	No prior approvals	~270 working days
Abridged Evaluation	Approved by 1 reference agency (e.g. USFDA, EMA, PMDA)	~180 working days
Verification Evaluation	Approved by 2+ reference agencies	~60 working days
Immediate Registration	Class A medical devices	~10 working days

Step 5 - Product Approval and Licensing

Once approved, products receive:

Step 6 - Post-Market Obligations

Companies are responsible for:

HSA conducts periodic inspections and may suspend or revoke licenses in case of non-compliance.

Regulatory Services

Are you launching your product in Singapore? Artixio helps you reduce regulatory risks and get your product registered efficiently in Singapore. Our team ensures the regulatory compliance with ASEAN CTD format, facilitating smooth market entry and sustained product success. Talk to our Singapore regulatory affairs consultant today. Let’s plan your successful market entry!