Singapore Medical Device License
Apply for a Medical Device Dealer's Licence
To apply for a medical device dealer's license in Singapore, you'll need to follow these steps:
1. Register your company in Singapore: If you don't have a local company, you'll need to register one with the Accounting and Corporate Regulatory Authority (ACRA).
2. Prepare necessary documents: You'll need to submit the following documents:
Completed application form
Company registration certificate
Proof of office address
Quality Management System (QMS) documentation (ISO 13485 certificate or GDPMDS certificate)
List of medical devices to be dealt with
Other supporting documents as required
3. Submit the application: You can submit your application online through the Medical Devices Information and Communication System (MEDICS).
4. Pay the application fee: The fee for a medical device dealer's license varies depending on the type of devices you'll be dealing with.
5. Await approval: The Health Sciences Authority (HSA) will review your application and may request additional information or documentation. Once your application is approved, you'll receive your license.
Additional tips:
Ensure that your QMS documentation meets the requirements of the HSA.
Be prepared to provide additional information or documentation as requested by the HSA.
Allow sufficient time for the application process.
Types of Licences
There are actually three main types of medical device dealer's licenses in Singapore, not just class-based ones. You've accurately described them:
Importer's License: This allows you to bring medical devices into Singapore.
Wholesaler's License: This allows you to sell medical devices by wholesale (including export), supply them for resale, or provide them as commercial samples. However, it doesn't cover selling to end-users (retail).
Manufacturer's License: This allows you to make, package, and label medical devices before supplying them. Licensed manufacturers don't need a separate Wholesaler's License for their own manufactured devices.
It's important to choose the correct license based on your specific business activities.
Fees and Turn-Around-Time
The fees and turnaround time for obtaining a medical device dealer's license in Singapore can vary depending on several factors, including the type of license you are applying for, the complexity of your application, and the number of devices you plan to deal with.
Here is a general overview of the fees and turnaround time:
Fees:
Class A license: The fee for a Class A license is typically higher than for a Class B license.
Class B license: The fee for a Class B license is lower than for a Class A license.
Importer's license: The fee for an importer's license is typically higher than for a wholesaler's or manufacturer's license.
Wholesaler's license: The fee for a wholesaler's license is typically lower than for an importer's or manufacturer's license.
Manufacturer's license: The fee for a manufacturer's license is typically the highest of all the licenses.
The exact fees can be found on the Health Sciences Authority (HSA) website or by contacting the HSA directly.
Turnaround time:
The turnaround time for obtaining a medical device dealer's license can vary from a few weeks to several months. The exact turnaround time depends on the complexity of your application and the number of devices you plan to deal with.
If you have any questions about the fees or turnaround time for obtaining a medical device dealer's license, you can contact the HSA.
For more information, you can visit the HSA website:
How Bestar can Help
Apply for a Medical Device Dealer's Licence
Bestar, a leading professional services firm in Singapore, offers comprehensive assistance throughout the process of applying for a medical device dealer's license. Our services include:
1. Company Registration and Setup: If you don't have a local company, Bestar can help you incorporate a company in Singapore. We will guide you through the necessary steps and ensure compliance with local regulations.
2. License Application Assistance: Bestar's experts can help you prepare the required documents, understand the application process, and navigate the regulatory requirements. We will ensure that your application is complete and accurate.
3. Quality Management System (QMS) Support: Bestar can assist you in establishing and maintaining a QMS that meets the requirements of the Health Sciences Authority (HSA).
4. Regulatory Compliance: Bestar can provide ongoing support to ensure that your medical device dealership complies with all relevant regulations and standards. We will stay updated on any changes in regulations and advise you accordingly.
By partnering with Bestar, you can streamline the process of applying for a medical device dealer's license and ensure that your business is compliant with all regulatory requirements. Our expertise and experience can help you navigate the complexities of the licensing process and focus on growing your business.
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