
Singapore Product Registration
We specialise in:
Government regulations, registration and approvals for product importation and sale in Singapore
Cosmetic products are defined as products that are applied to the skin, hair, nails, lips or mouth for the purpose of cleaning, protecting, perfuming or enhancing appearance. To be classified as a cosmetic product allowable for import and sale in Singapore, the ingredients of the product would need to comply with the requirements, based on the ASEAN Cosmetic Directive.
The label of the product also needs to comply with the regulations, including information that must be displayed, listing of ingredients and allowable claims.
The cosmetic product must be submitted for notification with the Singapore Health Sciences Authority (HSA) before it can be sold. An online database is available for the public to check on the notification status of cosmetic products in Singapore.
Companies distributing cosmetic products are also required to report on any adverse events related to their products and to follow through with the corrective action, with may include product recalls.
Our Services
We can assist you with your cosmetic product classification, notification, import, warehousing and distribution. This would include checking the ingredients and label of the product and doing the notification. The person doing the notification will also be the responsible person for the product. We can act as your in-country representative to fulfil the role of the responsible person. We can also act as your in-country representative to monitor your products and handle adverse events if they occur.
Devices that are meant for beauty and wellness, meant to support general well-being without specific medical claims, are not considered as medical devices and do not require registration. However, if medical or treatment claims are made or the function of the device goes beyond general well-being, it may be classified as a medical device, which requires distribution licensing and product registration with the Health Sciences Authority (HSA).
In addition, if the product is an electrical device with an AC adaptor and/or 3 pin plug, it will require registration for the Consumer Protection (Safety Requirements) Registration Scheme.
Our Services
We can assist you with your beauty/wellness device classification, registration (if required), import, warehousing and distribution, act as your in-country representative and ensure compliance to the claims, advertisements and promotions regulations.
Whilst personal care products may not be commonly referred to as cosmetics, if the product is applied to the skin, hair, nails, lips or mouth for the purpose of cleaning, protecting, perfuming or enhancing appearance, it is classified as a cosmetic product. This includes products like skincare, shampoo, toothpaste, hand and body wash.
Cosmetic products would require product notification with the Health Sciences Authority (HSA) and must meet the regulations governing cosmetic product, as detailed in the previous category.
Our Services
We can assist you with your personal care product classification, notification, import, warehousing and distribution. This would include checking the ingredients and label of the product and doing the notification. The person doing the notification will also be the responsible person for the product. We can act as your in-country representative to fulfil the role of the responsible person. We can also act as your in-country representative to monitor your products and handle adverse events if they occur.
Health supplements are regulated by the Health Sciences Authority (HSA) and are not subject to prior approvals and licensing for import and sale in Singapore. However, the responsibility lie on the importer and distributor to ensure that their products meet the requirements for health supplements and the safety standards.
For a product to be classified as a health supplement, it needs to be a product that is used to supplement a diet, with benefits beyond those of normal nutrients, and to support or maintain the healthy functions of the human body. If it does not meet this criteria, the product may be classified as a food instead. A food product has different requirements from health supplement in terms of ingredients, presentation, allowable claims and product labelling. The presence of some ingredients and claims may also make the product into a medicine, Chinese proprietary medicine or traditional medicine.
Health supplements need to meet safety and quality standards in the areas of not containing prohibited ingredients, limits on toxic heavy metals, limits on microbes, limits on vitamin and minerals. They also have to adhere to the labelling and claims regulations and perform adverse events reporting when needed.
Our Services
We can assist you with your health supplement classification and to design the label and claims to meet the regulations for health supplements, as opposed to a health food or a medicine. We will evaluate if your product meets the required safety and quality standards, including checks on the ingredients. We can assist with the import, warehousing and distribution, and act as your in-country representative to monitor your products and handle adverse events if they occur.
Health food products are products that are typically consumed as part of a normal diet. Their presentation are in forms such as beverages, grains, loose powders, bars etc, as opposed to health supplements which are usually in forms such as capsules, softgels, tablets and pills.
Health supplements and health foods are managed by different government agencies in Singapore. As the products in the two categories may be in many ways similar, the classification can create confusion as the distinction between the two is sometimes not clear. Sometimes, the presentation and claims on the label may be the only thing separating one from the other.
Health foods and health supplements have different regulations and allowable claims. They are also governed by different legislative Acts. Health foods, regulated by the Singapore Food Agency (SFA), do not require registration for the import and sale in Singapore but they need to comply with the food regulations. Companies importing health food would also need a food import license, as well as a customs account. A locally incorporated company is needed to apply for the food import license and customs account.
Our Services
We can assist you with your health food classification and to design the label and claims to meet the regulations for health foods. We can assist with the application for the food import license and customs account. We can also assist with the import, warehousing and distribution, and act as your in-country representative for your customs account, to monitor your products and handle adverse events if they occur.
All pesticide and repellent products intended for use against the five vectors (i.e. mosquitoes, flies, rodents, cockroaches and rat fleas) in Singapore are required to be registered with the National Environment Agency (NEA). It is an offence under the Control of Vectors and Pesticides Act (CVPA) for any person to advertise, sell or supply vector control pesticides and repellents which are not registered.
Certain pesticides and repellents also require a Hazardous Substances Licence/Permit issued by the Development Control & Licensing Division (National Environment Agency) prior to registration.
Our Services
A Singapore resident and a Singapore incorporated company is required to register pesticides and repellents. We can act as your representative to do the registration and amendments to registration.
Companies that meet certain criteria are required to comply with the Mandatory Packaging Reporting (MPR) regulated by the National Environment Agency (NEA). The criteria are companies that carry on a business of supplying regulated goods in Singapore, have annual turnover of more than S$10 million and import/use specified packaging.
Such companies are also required to submit their 3R (Reduce, Reuse, Recycle) plans.
Our Services
We can assist you with the submission of the required reports and drafting of your 3R plans.
Chinese Proprietary Medicine (CPM) is regulated by the Health Sciences Authority (HSA) and refers to a medicinal product that is in the form of a finished product, such as capsule or tablet, and where all the active ingredients are documented as traditional Chinese medicine. There is a government database of allowable active ingredients in CPM products that needs to be complied with. CPM products do not contain any chemically-defined isolated constituents as an active ingredient. Simply put, they do not contain any ‘Western’ active ingredients.
In order to import and distribute CPM products, a dealer’s license is needed and the products need to be registered. The dealer’s license comprise of the import, wholesale and/or manufacturing licenses.
CPM products need to adhere with the restrictions on prohibited ingredients, limits on naturally occurring substances, toxic heavy metals and microbes, labelling requirements and advertising and promotions regulations.
To apply for the dealer’s license to import and sell CPM products, a locally incorporated company is required. This company will need to submit its storage/warehouse layout plan, Good Distribution Practice standard operating procedure and Good Distribution Practice records. If the company outsource its logistics, then the logistics vendor will need to supply the necessary documents, as well as be subjected to the regular Good Distribution Practice audits by the health authority.
As CPM is considered a medicine, it is subjected to the Medicines Advertisements Regulations. A permit is required prior to any advertisement or sales promotion activities.
Our Services
We can assist you with your CPM classification and registration, dealer license application, set up of Good Distribution Practice, import, warehousing and distribution, act as your in-country registrant and liaison, and ensure compliance to the claims, advertisements and promotions regulations. The person doing the registration will also be the responsible person for the product. We can act as your in-country representative to fulfil the role of the responsible person. We can also act as your in-country representative to monitor your products and handle adverse events if they occur.
Medical devices are regulated by the Health Sciences Authority (HSA) and are devices used to diagnose, alleviate or treat a medical condition. They can also be devices to measure or monitor functions of the body e.g. thermometers, blood pressure monitors.
Companies would need a dealer’s license to import and sell medical devices in Singapore. The dealer’s license includes the importer, wholesaler and manufacturer licenses. To obtain these licenses, an ISO 13485 certificate or a Good Distribution Practice for Medical Devices certificate may be required.
Medical devices may also require registration, depending on their risk level, which range from class A to D. Class A (low risk) medical devices are exempted from registration. Class B, C and D medical devices would require registration. For classes requiring registration, the time needed will depend on the evaluation routes. This can range from immediate upon submission to up to a year for full route evaluation for a high risk product. Quicker evaluation routes can be obtained if the medical devices have received prior approvals from the Singapore government’s overseas reference regulatory agencies, such as US FDA, EU NB, Australia TGA.
Our Services
We can assist you with your medical device classification and registration, dealer license application, set up of Good Distribution Practice, import, warehousing and distribution, act as your in-country registrant and liaison, and ensure compliance to the claims, advertisements and promotions regulations.
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Quick Start
We can help you set up your Singapore company for your product registration and import, or you can skip all that, do away with the bureaucracy, and use our company to act on your behalf.
2
smooth operations
Aside from product registration, we can also assist you with your operations, from importation, to warehousing, to deliveries, to customer service.
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highly competent
We don't just do paperwork. Our consultants have extensive experience in new market business development, have worked in senior management positions in MNCs and have MBA degrees.
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WORK REMOTELY
Business can be done remotely yet efficiently; without the need for costly travel. We can help you expand your business, act as your local representative, while you do everything online.
Singapore Product Registration has helped many companies set up and grow their businesses in Singapore and throughout Asia since 2006. Aside from product approval and registration, our services also include company set up, logistics management and business advisory.