Singapore launches new E-FORM for Therapeutic Products(TP)

Health Sciences Authority (HSA) Singapore launches a new online form to enable submission of post-approval documents/data of therapeutic products (TP) registration conditions.

The applicants need to fill up 9 fields in the short form which allows multiple registrations for multiple products. The same form is applicable for multiple products provided all products fulfill the same registration condition.

Registrant may access the online form with a CorpPass credential. The CorpPass credential is the same as when registrants access PRISM to submit applications for TP. HSA protects confidentiality through CorpPass.

All registrants will receive an email reminder pertaining to outstanding registration from 1 May 2020 onwards. Applicants are not required to  reply to the email instead submit documents via the e-form.

The form can be accessed at https://form.gov.sg/#!/5e815490ed9a570011b43a25

Singapore launches new e-form for post-approval Registration Conditions of Therapeutic Products

Health Sciences Authority (HSA) Singapore launches a new online form to enable submission of post-approval documents/data of therapeutic products (TP) registration conditions.

The applicants need to fill up 9 fields in the short form which allows multiple registrations for multiple products. The same form is applicable for multiple products provided all products fulfill the same registration condition.

Registrant may access the online form with a CorpPass credential. The CorpPass credential is the same as when registrants access PRISM to submit applications for TP. HSA will protect the confidentiality of the submitted documents by going through CorpPass.

All registrants receiving e an email reminder pertaining to outstanding registration from 1 May 2020 onwards are not required to reply to the email but instead will have to submit documents via the e-form.

The form can be accessed at https://form.gov.sg/#!/5e815490ed9a570011b43a25

 

Field Safety Corrective Action (FSCA) launched by HSA Singapore

Effective from 6 April 2020, the Health Science Authority(HSA ) of Singapore has launched the new OSCAR system for Field Safety Corrective Action(FSCA).

Reporting and monitoring of FSCA have shifted from email to online system and currently, companies are required to register themselves through the  OSCAR system.

Firstly, for the devices that are manufactured or supplied in Singapore, HSA requires a Notification Report (MDRR1 form ) to be submitted via OSCAR. This is then followed by a Final Report (MDRR2 form) within 21 days.
OSCAR system provides the online content of the forms for users.

On the other hand, for medical devices that are yet to be supplied in Singapore but registered via Special Access Route (SAR), users are required to submit a MDRR3 form within 30 days of initiating an FSCA.

HSA will also issue an acknowledgment of receipt of the FSCA report to the reporting person along with the actions to be taken.

Among the actions include labeling changes, the supply of CIP (correction in progress medical devices), recall and cease of supply.

A 3 months transitional period was provided to dealers to submit the FSCA report via the OSCAR system, however effective from the above date, HSA only accepts online submission.

For more information, please refer to

https://www.hsa.gov.sg/medical-devices/field-safety-corrective-action/how-to-report

 

 

Singapore adds controls to certain mercury-added medical devices under EPMA

Singapore adds certain medical devices to the control list of Mercury-Added Products under the Environmental Protection and Management Act (“EPMA”).

From 1 January 2020 onwards, the manufacturing, import and export of the following mercury-added medical devices will not be allowed:

•                    Barometers
•                    Hygrometers
•                    Manometers
•                    Thermometers
•                    Sphygmomanometers

The exceptions are installed large scale equipment or equipment used for high precision measurements, where there are no non-mercury alternatives available in the market.

The importation and sale of new mercury clinical thermometers for local use in Singapore have not been allowed since 1 July 2009.

More details can be found in the Singapore customs website in this link:

http://www.customs.gov.sg/-/media/cus/files/circulars/ca/2019/nea-pcd-hs-circular-for-mercury-added-products_14112019.pdf

Singapore HSA released registration requirements on Next Generation Sequencing IVDs

Singapore, Health Sciences Authority (HSA) released the final document on Next Generation Sequencing NGS IVDs.

This document focuses on the requirements of NGS IVDs for registrations.

The scope covers both NGS based IVD tests intended to aid in the diagnosis of individuals with suspected germline or somatic mutation-related diseases and NGS based tumor profiling IVD tests.

These guidelines add to the list of the Product-Specific Regulatory Guidelines:

•                    Telehealth Products
•                    FAQ Telehealth Products
•                    Aesthetic-Related Guidelines

The guidelines can be found at https://www.hsa.gov.sg/medical-devices/guidance-documents