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Health Sciences Authority
NEX2US Newsletters

NEX2US FLASH - Issue 01 | May 2016

Audiences

Healthcare professional

Industry member

Product type

Cell, Tissue and Gene Therapy Products

Chinese Proprietary Medicines

Controlled drugs

Cosmetic products

Health supplements

Homeopathic medicines

Medical devices

Psychotropic substances and poisons

Therapeutic Products

Tobacco control

Traditional medicines

1 May 2016

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INFO-BYTE 1

MAY 2016
IMPORT DECLARATION FOR HEALTH PRODUCTS SIMPLIFIED IN TRADENET
Import declaration of health products to TradeNet® is streamlined and simplified to facilitate customs cargo clearance effective 03 May 2016.

INFO-BYTE 2

APRIL 2016
REFINEMENTS TO THE FIELD SAFETY CORRECTIVE ACTIONS (FSCA) PROCESS
We have refined our FSCA notification process to make it more efficient and easy for reporting. The guidance documents for FSCA notification are effective 18 April 2016.

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INFO-BYTE 3

APRIL 2016
ALLOWING THE SALE AND IMPORT OF CHINESE HERBS CONTAINING BERBERINE
Chinese herbs containing berberine are allowed for sale and import effective 01 April 2016.

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INFO-BYTE 4

DECEMBER 2015
SIMPLIFIED CHANGE NOTIFICATION PROCESSES FOR MEDICAL DEVICE
The application of Change Notification for Medical Device has been simplified and enhanced to allow clearer understanding of the timelines and ease in applications.

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INFO-BYTE 5

MAY 2016
LAUNCH OF ONLINE MEDICAL DEVICE CLASSIFICATION TOOL
Determining risk class of your medical device is now as easy as ABC. With just a few clicks, you will be able to find out the risk classification of the medical device that you want to register.

The online tool is also one of the winning entries in the Public Sector Pro-Enterprise Initiative organised by Ministry of Trade and Industry (MTI) for the period September 2015 to February 2016.

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