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Regulatory Affairs Consulting 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.
Our Regulatory Affairs Consulting Services 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
- Therapeutic Products: New Chemical Entities (NCEs), Generics, Biosimilars
- Medical Devices: Classified as Class A (low risk) to Class D (high risk)
Step 2 - Appoint a Local Authorized Representative (LAR)
Step 3 - Dossier Preparation
- Drugs: ASEAN CTD format is required (Modules 1–5)
- Devices: Common Submission Dossier Template (CSDT)
- Cosmetics: Notification via the ASEAN Cosmetic Directive portal
- Biologics: Additional stability and safety data may be required
Step 4 - Application Submission & Evaluation
| 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
- Certificate of Product Registration (5-year validity for therapeutic goods), subjected to renewal
- Singapore Register of Therapeutic Products (SRTP) or SMDR listing (for medical devices)
Step 6 - Post-Market Obligations
- Reporting adverse events
- Submitting Periodic Safety Update Reports (PSURs)
- Maintaining GMP compliance and renewing licenses before expiry
- Filing variations for any change in formulation, labeling, or manufacturing site
Why Choose Artixio For RA Services In Singapore
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!
FAQs
Does HSA accept US FDA or EMA approvals to simplify the review?
Can a company hold multiple licenses for the same product?
What is the process for renewing marketing authorizations?
Is local clinical data mandatory for new drugs?
Still Have Questions ?
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