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This application is a service of the Singapore Government.

Health Sciences Authority

Import Declaration at Tradenet

The Health Sciences Authority (HSA) has undertaken a review of the import declaration requirements for health products, with the goal to streamline trade documentation of health products imported into Singapore and to facilitate the submission of import permit applications via TradeNet.

With effect from 3 May 2016, key changes, as summarized below, will be implemented:

  1. Merger of the 4 Competent Authorities (CAs) for health products into single unit.
  2. Removal of the need to declare HSA Product Codes for health products that are currently not subject to licensing/approval requirements.
  3. Simplification of HSA Product Codes.

One Single Competent Authority(CA) For All Health Products Controlled by HSA

The current 4 CAs of HSA in TradeNet, i.e. Cosmetic Control Unit (CCU), Medical Device Branch (MDB), Complementary Health Products (CHP), and Health Products Regulation Group (HPR), will be merged into a single CA (i.e. HPR). With this initiative, different categories of health products may be declared within the same TradeNet permit application.

New and Simplified HSA Product Codes

For the following health products that are subject to HSA’s licensing/approval requirements before importation, an importer or dealer is required to submit import declarations using applicable HSA Product Codes and to furnish the relevant licence/approval information:

  Category of Products Main Legislation
1 Therapeutic Products including therapeutic gums
  • Health Products (Therapeutic Products) Regulations 2016
2 Medical Devices
  • Health Products (Medical Devices) Regulations 2010
  • Health Products (Medical Devices)(Amendment) Regulations 2016
3 Chinese Proprietary Medicines
  • Medicines (Traditional Medicines, Homeopathic Medicines and Other Substances (Exemption) Order
4 Medicinal or Therapeutic products used in clinical research
  • Medicines (Medicinal Products as Clinical Research Materials) Regulations 2016
  • Health Products (Therapeutic Products as Clinical Research Materials) Regulations 2016
5 Controlled drugs and Psychotropic substances
  • Misuse of Drugs Regulations 
  • Medicines (Export Licence for Psychotropic Substances) Regulations
  • Health Products (Therapeutic Products) Regulations 2016
6 Oral dental gums
  • Regulation of Imports and Exports (Chewing Gum) Regulations
  • Health Products (Oral Dental Gums) Regulations 2016
7 Substances specified as “Poisons”
  • Poisons Act and Rules

For the import of the above categories of health products, HSA has also reviewed and simplified the HSA Product Codes into 5 Product Codes as tabulated in Table 1 below. The five HSA product codes are to be used from 3 May 2016:


Table 1: HSA Product Codes that will be implemented from 3 May 2016

Product Codes Applicable for Import of:

HSAHP

  • Registered therapeutic products,
  • Registered medical devices,
  • Class A medical devices (non-sterile),
  • Listed Chinese proprietary medicines and
  • Registered oral dental gums;

not containing controlled drugs or psychotropic substances.

HSAIFRSA
  • Medicinal products, 
  • Therapeutic products, 
  • Medical devices and 
  • Chinese proprietary medicines;

not containing controlled drugs or psychotropic substances and imported with special authorisation or approval from HSA on a consignment basis.
E.g. Imports of medicinal or therapeutic products for clinical research, imports of therapeutic products for use by named patients, imports for re-export, imports for supply to ships and aircraft, imports for non-clinical purposes (such as laboratory/stability testing, machine test runs, investigations, destruction/ disposal, static displays in exhibitions, etc.)

HSAPOIS
  • Substances specified in the Poisons Act including raw materials, laboratory reagents and reference standards not including controlled drugs or psychotropic substances

HSACDPSY

  • Substances regulated as controlled drugs under the Misuse of Drugs Act
  • Substances regulated as psychotropic substances under the Medicines (Export Licence for Psychotropic Substances) Regulations
  • Therapeutic products and clinical research materials containing psychotropic substances specified in the Health Products (Therapeutic Products) Regulations 2016
  • All products containing controlled drugs or psychotropic substances.
  • Products containing controlled drugs or psychotropic substances imported for personal use.
HSAIPU
  • Therapeutic products,
  • Medical devices, and 
  • Chinese proprietary medicines;

not containing controlled drugs or psychotropic substances and imported for personal use only.


License/Approval Information To Be Declared Using HSA Product Codes

In addition to the HSA Product Codes in Table 1 above, importers and dealers are also required to furnish all relevant HSA licence/approval information in the CA/SC code 1, 2 and 3 fields, where applicable. Details of the information to be furnished for therapeutic products, medical devices, Chinese proprietary medicines and other types of imports are provided in Tables 2 to 5.
 

Information to be Declared for Health Products Subjected to Licensing/Approval Requirements

The Tables 2 to 5 below provide guidance to importers and dealers on licence information and/or other approval information that needs to be declared and the specific CA/SC Code fields that they should use to provide the information.

Table 2       Therapeutic Products

Table 3       Medical Devices

Table 4       Chinese Proprietary Medicines

Table 5       Other Products regulated by HSA including Poisons, Controlled Drugs, Psychotropic Substances and Oral Dental Gums”

The following health products are currently not subject to HSA’s licensing/approval requirements before importation. Hence, they are no longer required to be declared with HSA’s Product codes in the permit applications submitted via TradeNet.

  1. Cosmetic products
  2. Health supplements
  3. Quasi-medicines
    (E.g. anti-dandruff preparations, medicated soaps, medicated plasters, medicated beverages, vitamin or nutritional preparations from any plant, animal or mineral, medicated toothpaste, medicated cosmetic products for treatment of pimples or acne which are exempted from product registration requirement)
  4. Traditional medicines such as Jamu and Ayurvedic medicines
    (Excluding Chinese proprietary medicine)
  5. Medicated oils and balms
  6. Herbal materials
  7. Homoeopathic medicines

Frequently Asked Questions (FAQs)

Read the list of “Frequently Asked Questions” which will address some of the questions that you may have.

TradeNet declaration process and information for health products

Specific information for different categories of health products to be declared when submitting import permit applications at the TradeNet is available here.

Industry Circular

The circulars sent to the Importers, Traders and Declaring Agents can be read here:

001/2016      Changes to Import Declaration Requirements for Health Products from 3 May 2016

003/2016      Changes to Information to be Declared for Import of Health Products from 1 November 2016

Helplines

For further clarifications, please email to: HSA_TradeNet@hsa.gov.sg or Tel: 6304 5857.
(Office hours Mon-Fri: 8.00 am to 5.00 pm excluding lunch hour: 12.00 pm to 1.00 pm; Weekends and Public Holidays: Closed)