OMC Medical
OMC Medical

 Cosmetics Registration in Singapore

Regulatory Authority:

Health Sciences Authority

Link for RA:

https://www.hsa.gov.sg/

Local regulation:

Health Products Act and its Health Products (Cosmetic Products – ASEAN Cosmetic Directive) Regulations 2007 (the Regulations) 

Who can register : 

  • Manufacturers
  • Importers

Data to be communicated :

  1.  The cosmetic product’s category and name or names, which enable it to be identified.
  2. The person’s name and address in charge of making the product information file accessible.
  3. In the case of imports, the country of origin
  4. In an emergency, the contact information for a physical person to call.
  5. Nanoparticles (substances in the form of nanomaterials) are present.
  6. The name of a material identified as carcinogenic, mutagenic, or hazardous for reproduction, as well as the Chemical Abstracts Service (CAS) or EC number (CMR)
  7. In the event of a problem, the frame formulation allows for rapid and appropriate medical treatment.

Process:  

  Before filing a product notification, 

  • Verify that the ingredients in your cosmetic product meet the standards of the ASEAN Cosmetic Directive’s Annexes.
  • Ensure your product meets the labelling regulations. 

  Submitting a product notification

  • Create a Client Registration and Identification Service (CRIS) account
  • To notify the FDA about a new cosmetic product, use PRISM. 

   Following the submission of a product notification, 

  • Adhere to the company responsibilities
  • Submit an adjustment to alter the applicant’s information, the company’s information, or the manufacturer’s information.
  • After one year, re-notification is required.
  • If you are no longer selling the product, cancel the notice.

Timeframe and fees:

 The same fees apply for both product notification and re-notification.

Product or variants

Annual fee

Single higher risk product

$26

First three variants of higher risk product

$26 per variant

Fourth and subsequent variants of higher risk product

$6 per variant

Single lower risk product

$11

First three variants of lower risk product

$11 per variant

Fourth and subsequent variants of lower risk product

$6 per variant

 

Application type

Fee

Application for Good Manufacturing Practice certificate (valid for 3 years)

$4,120

Application for issuance of additional certificate

$206

 

Additional information: 

Each notification has a one-year expiration date. 

The information on the label must be written in English. If other languages are available, they may be utilized in addition to English and should be identical to the English version.

For products sold locally, Singapore Customs offers a Certificate of Free Sale.