Market Authorization Holder in Singapore
Bringing a healthcare product into Singapore’s tightly regulated market? You’ll need a local entity to legally hold the registration license. That’s where a Marketing Authorization Holder (MAH) comes in and Nyprax Pharma is here to handle that responsibility with precision, speed, and decades of regulatory experience.
What Is a Marketing Authorization Holder (MAH)?
A Marketing Authorization Holder (MAH) is the legal entity responsible for ensuring that a pharmaceutical or medical product complies with the regulations of the country in which it is being marketed. In Singapore, the MAH holds the product registration license with the Health Sciences Authority (HSA).
A foreign entity can collaborate with a locally appointed distributor, who will hold the required license. It is mandatory that the license holder be a local entity. However, by becoming an independent Marketing Authorization Holder (MAH), the manufacturer or principal gains greater flexibility and control, enabling them to implement more effective marketing strategies while working with local importers and distributors.
Why Appoint a Market Authorization Holder in Singapore?
As Singapore is a well-regulated healthcare markets in Asia, any pharmaceutical, biological, or medical device product must be registered under a local entity license holder before it can be imported or sold. For companies without a local presence in Singapore, appointing an experienced MAH like Nyprax Pharma simplifies the regulatory pathway and accelerates your market entry.
Nyprax Pharma: Your Trusted MAH Service Provider in Singapore
With over 30 years of regulatory experience and more than thousands of medical devices registered, Nyprax Pharma is a trusted partner for companies looking to navigate the complex Singaporean regulatory environment.
We act as the legal license holder for your product registrations, ensuring compliance with all HSA regulations while streamlining the approval process.
Whether you’re launching a medical device or pharmaceutical we provide the expert representation needed to bring your product to market.
Explore our Medical Devices Registration!
Our Role as Your Market Authorization Holder
When Nyprax Pharma is appointed as your market authorization holder in Singapore, we:
- Serve as the legal license holder for product registration with HSA
- Submit and manage your product registration dossier
- Coordinate with regulatory authorities for query resolution and variation applications
- If local manufacturer requests our support, we handle the reporting.
- Maintain product dossiers in alignment with HSA compliance requirements
- Ensure timely license renewals and lifecycle management
- Liaise between you and the HSA to provide continuous regulatory updates and guidance
This allows you to focus on core business activities while we handle the process.
Benefits of Appointing Nyprax Pharma as Your MAH
Proven Track Record
We’ve supported over 500 companies in registering and maintaining healthcare products in Singapore and Malaysia.
Fast, Efficient Approvals
Our team knows the regulatory system inside and out. We streamline the submission process to reduce time to market.
Regulatory Peace of Mind
We ensure that your product is always compliant with the latest HSA regulations, minimizing the risk of regulatory issues.
Full Transparency
You maintain ownership and control of your product, while we handle the legal responsibilities and administrative requirements.
Local Presence, Global Reach
We work with international clients who want to enter Singapore without a local subsidiary. With us, you gain a local partner with regional expertise.
Who We Work With?
We provide market authorization holder services to a wide range of companies, including:
- Pharmaceutical companies seeking Singapore market entry
- Startups and established firms with no local legal entity
The Regulatory Import License Process at a Glance
- Initial Consultation & Regulatory Strategy : We assess your product type and determine the best regulatory route.
- Dossier Preparation & Review : We compile, format, and submit the registration dossier to the HSA.
- Submission as MAH :Nyprax Pharma submits the application and acts as the license holder.
- Approval & Post-Market Support:Once approved, we maintain the license and support all post-market obligations.
- Appointment of Importers / Distributors:- Upon manufacturer instructions, we can appoint distributors or remove
Need an MAH in Singapore?
Let’s simplify your product registration and compliance journey.
Contact us for a free consultation today!
Frequently Asked Questions
What is a Marketing Authorization Holder (MAH)?
An MAH is the legal entity responsible for holding the registration license of a healthcare product in Singapore. They ensure the product complies with all HSA regulations from registration through to post-market surveillance.
Who can be a Marketing Authorization Holder?
Only companies with a legal presence in Singapore can act as an MAH. Foreign companies must appoint a locally registered entity like Nyprax Pharma to fulfill this role.
What are the responsibilities of an MAH?
An MAH manages product registration, communicates with the HSA, ensures regulatory compliance, handles post-market surveillance, and maintains documentation throughout the product’s lifecycle.
Can I change my MAH later?
Yes, but the process involves regulatory submission and transfer of responsibility. Nyprax Pharma can assist in seamless MAH transitions with minimal disruption.
How long does product registration take under an MAH?
Timelines vary depending on the product type, but our streamlined approach often accelerates the process. Most medical device applications are processed within 4 to 9 months.
What’s the cost of appointing an MAH?
Costs depend on the type of product and level of regulatory support needed. Contact us for a tailored quote based on your requirements.
Can Nyprax Pharma act as MAH for multiple products or companies?
Absolutely. We represent over 500 companies and can act as MAH for a wide portfolio of products across categories.