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Medical Device Branch (MDB)
The Health Products Regulation Group (HPR) is the controlling authority for the importation of:
- Medical devices (including condoms and contact lens solutions);
A. Procedures for the import of Class C and D Medical Devices
- From 01 June 2011 onwards, for the import of
Class C and D medical devices, traders need to provide the following information during TradeNet® declaration.
- A valid Importer’s licence number is to be declared in ‘Licence No.’ field for all imports except medical devices imported for clinical trial and personal use. For medical devices imported for clinical trial and personal use, ‘Licence No.’ is to be left blank
- A valid HS Code controlled by MDB in ‘HS Code’ field (e.g. HS code line 1 is 40141000 for item “natural brand water based condoms”. HS code line 2 is 40141000 for item “Rabbit condoms”)
- A valid Product Code corresponding to the HS Code to be declared in ‘CA/SC Product Code’ field
EITHER
- A valid medical device registration number (SMDR Listing No.) or a Transition List No. to be declared in ‘CA/SC Code 1’ field with ‘CA/SC Code 2’ field left blank
OR
- A valid approval number (for Authorisation Routes, Clinical Trials, Custom-Made, Refurbished or Personal Use Only) is to be declared in ‘CA/SC Code 2’ field with a ‘NA’ declaration in ‘CA/SC Code 1’ field
- Quantity to be imported in ‘HS Quantity’ field.
- HS Quantity Unit of Measurement declared must match that of the Product Code Quantity Unit of Measurement
1. For the import of medical devices that are
subject to TradeNet® controls by another Controlling Agency (CA), traders are to declare in accordance to the requirements of these prevailing CA. For example, medical devices that are also controlled by National Environment Agency – Centre for Radiation Protection and Nuclear Science (NEA-CRPNS), traders are to declare according to NEA-CRPNS requirements via TradeNet®.
2. Additionally, for the import of condoms (HS Code 40141000) intended for supply in Singapore, the following information is to be submitted to MDB upon TradeNet® declaration approval, via fax at 6478 9028.
- TradeNet® Declaration Form or Cargo Clearance Permit (containing the Importer’s name)
- Invoice
- Packing List containing Brand Names, quantity of each consignment and batch numbers
3. Additionally, for the import of contact lens solutions (HS Code 33079020) intended for supply in Singapore, the following information is to be submitted to MDB upon TradeNet® declaration approval, via fax at 6478 9028:
- TradeNet® Declaration Form or Cargo Clearance Permit (containing the Importer’s name)
- Invoice
- Packing List containing Brand Names, quantity of each consignment and batch numbers
- Product owner’s Certificate of Analysis (COA) containing information on particulate matter content and product sterility for each Brand name and batch number.
B. Procedures for the import of Class A and B Medical Devices
a. For the import of Class A and B medical devices:- From 01 Jun 2011 to 31 Dec 2011
- For HS codes that are controlled by MDB, traders are to declare ‘MISC’ in ‘CA/SC Product Code’ field with both “CA/SC Code 1” and ‘CA/SC Code 2’ fields left blank
- For HS codes that are NOT controlled by MDB, traders are to declare in accordance to other applicable Controlling Agency’s requirements.
b. From 01 Jan 2012, Class A and B medical devices will be declared under their relevant HS Codes and Product Codes.
Refer to link for HSA (MDB) product codes
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