Health Sciences Authority HSA

Import Declaration of Health Products

 

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

 

 

S/N

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 2016

3

Chinese Proprietary Medicines

  • Medicines (Traditional Medicines, Homoeopathic 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

 

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 import permit applications submitted via TradeNet.

a) Cosmetic products;
b) Health supplements;
c) 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)
d) Traditional medicines such as Jamu and Ayurvedic medicines;
    (excluding Chinese Proprietary Medicines)
e) Medicated oil and balm;
f) Herbal materials; and
g) Homoeopathic medicines

 

 

HSA Product Codes

 

Table 1. HSA Product Codes

 

Product Codes

Applicable for Import of:

HSAHP

  • Registered therapeutic products,
  • Registered medical devices,
  • Class A medical devices,
  • Listed Chinese proprietary medicines and
  • Registered oral dental gums;

They should not contain controlled drugs or psychotropic substances.

 

HSAIFRSA

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

They should not contain 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

HSAIPU

  • Therapeutic products,
  • Medical devices, and 
  • Chinese Proprietary Medicines;
They should not contain controlled drugs or psychotropic substances and imported for personal use only. 

 

 

License/Approval Information To Be Declared With 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

When submitting a declaration, please observe the following requirements:

  1. Declare each product on separate item serial number using the applicable HSA Product code.
  2. Product Code Unit of Measurement (UOM) must match the declared HS UOM.
  3. Do not declare more than one item for each item serial number, even if the products share the same HS code.
  4. Declare the full product name as stated on the product label.
  5. Declare the relevant licence/approval information in the CA/SC Code fields. Specific information to be declared is provided in Tables 2 to 5 below.

Tables 2 to 5

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”

 

Frequently Asked Questions (FAQs)