Latest procedures for establishing a medical equipment and supplies trading company in Singapore

The medical equipment, medical services, medical equipment and supplies, and raw materials for manufacturing medical equipment in general in Singapore are managed and supervised by the Health Sciences Authority (HSA).

This agency is responsible for managing and promulgating regulations and national legal frameworks for drugs, products, medical supplies and equipment.

To be able to trade in medical devices or start medical-related business activities in Singapore, a company established in Singapore needs to be licensed by the HSA.

HSA requires companies to obtain a license before manufacturing, importing or supplying medical devices. Business research article Procedures for importing medical equipment into Singapore of GLA to understand the work needed to prepare before doing medical equipment business in Singapore. 

According to the Health Sciences Authority (“HSA”), medical devices are defined as medical products that have a physical or mechanical effect when used on the human body. These devices are used to:

• Diagnose, alleviate or treat a health problem, e.g. X-rays, contact lenses, prosthetic knees, etc.
• Measure or monitor body functions, e.g. blood pressure or blood glucose monitors, etc.

Therefore, products used to maintain or support general health without specific medical claims, such as body toning devices, accessories and massagers, would not be considered medical devices.

Understanding the HSA definition will allow businesses to know clearly whether their business activities are truly medical device business or not from the beginning, helping businesses confidently conduct business activities to sell products without having to apply for a license and meet other requirements.

If your business is still wondering whether your business product is a medical device, you can check more carefully through the following link of HSA: Is it a medical device? Or contact GLA today for detailed advice and to check whether your business's product information is a medical device in Singapore or not?

To successfully open a medical device company in Singapore, the Enterprise will also need to consider whether the Enterprise's product is a medical device or not. If so, the Enterprise establishing a medical device business company in Singapore will also need to check what type of medical device product it is in order to apply for the corresponding license.

Generally, medical devices in Singapore will be classified into 4 grades based on risk level – Grade A, B, C and D. Grade A is the lowest risk and Grade D is the highest risk.

In addition, Enterprises also need to consider factors affecting medical device risk classification including:

• Duration of medical device contact with human body (Degree of Invasiveness).
• Does the medical device deliver medicinal products to the user (e.g., infusion)?
• Does the medical device have certain effects on the user (e.g. stinging, itching).
• Other factors.

If the Business is still wondering whether the medical device belongs to the classification, the Business can check more carefully through the following link of the HSA agency: Registration overview of medical devices Or contact GLA today for detailed advice.

Each medical device will need to go through a specific assessment process. The assessment process for your medical device will depend on the following factors:

• Equipment risk classification.
• The number of pre-approvals given by the reference regulatory authorities in foreign countries (Japan, Europe, USA, Canada, Australia, etc.).
• Marketing history for the device.

The device evaluation roadmap will determine the turnaround time (TAT), fees, and documentation required for registration.

The conditions for doing business in medical devices in Singapore will include the following factors:

• Company formation in Singapore: This is a prerequisite before starting a business in Singapore. GLA will support businesses with a complete, reputable and professional service of establishing a company in Singapore.
• Registering medical devices with HSA: Depending on the medical device product, the registration process will be different.
• Registering a business license with HSA: This is especially important if the business is doing business within Singapore. The process of registering a medical device business license depends on the business purpose of the Enterprise, the type of license to register will be different.
• Sign up Goods and Services Tax (GST): if the business has domestic business in Singapore or the business's global turnover is expected to exceed S$1 million.
• Register custom code or import-export license if goods - medical equipment are imported, exported and stored in Singapore.

Once the Enterprise meets the above conditions, the Enterprise will be allowed to start medical equipment business in Singapore.

If the Enterprise only needs to establish a company to import medical equipment for export to other countries, it is not necessary to register the equipment with HSA. However, the Enterprise will need to declare in the form of Special Access Routes with the Singapore authority.

GLA's Singapore company formation service usually takes 3 - 5 days to complete. Depending on the purpose of opening a company and the type of medical device registered, the time for medical device registration and business license registration will vary significantly.

Contact GLA today for detailed advice today.

Opening a medical equipment business in Singapore does not require a minimum charter capital, with only 1 SGD charter capital, a business can establish a company in Singapore.

GLA with a team of professional, experienced consultants and partners of banks in Singapore will advise and support businesses to open a bank account suitable for the business.

• Online bank account: quick account opening procedures and documents;
• Physical bank account: takes time (1-3 months), account opening process is more complicated than online banking.

Medical equipment businesses should note that opening a bank account for a Singapore company trading in medical equipment at traditional Singapore banks is increasingly difficult. Businesses need to find a consulting unit with extensive experience in consulting on payment solutions to advise and accompany.

In addition, it is not easy for medical equipment businesses to open a bank account for a Singapore company trading in medical equipment at online banks because the medical equipment sector is always a sensitive sector, included in the non-priority support policies of online banks because of its large value and easy involvement with sensitive political factors.

Therefore, before opening a bank account for a Singapore company trading in medical equipment, businesses should contact GLA to be assessed for the opportunity to successfully open a bank account in a professional and free manner.

GLA can fully support Enterprises to establish a company in the country that the Enterprise desires such as the US, Hong Kong, Thailand, Japan, UAE, Malaysia, etc. to offshore countries such as BVI, SVI, Seychelles, Belize, etc.

Contact GLA today for detailed advice today.