INDIA: Implementation of IS/ISO 15197: 2013 on Glucometer Test Strips – June 2018

• 2020-02-14 04:13:25

The regulatory standards for the approval of IVD devices keep on changing time to time because of the continuous improvements and modifications made related to their better performance level. There was a revision for “glucometer test strips” in 2013 as mentioned in IS/ISO 15197: 2013.

More

INDIA: Central Drugs Standard Control Organization (CDSCO) arranges a Proposal for Designation of Central Testing Laboratories for Medical Devices and In-Vitro Medical Device – April 2018

• 2020-02-14 07:40:37

In light of the new Medical Device Rules 2017, CDSCO/CLA/SLA shall have updated information of laboratories involved in testing of medical device & in vitro diagnostics with respect to their laboratory reports and decision on performance evaluation of products made by stakeholder/regulator.

More

SINGAPORE: Cybersecurity Labelling Scheme for Medical Devices ( CLS(MD) Sandbox: Latest Updates and Calls for Medical Device Manufacturers

• 2024-06-19 09:35:10

The rise of connected medical devices has revolutionized healthcare, but it has also introduced new cybersecurity challenges. To address these concerns, Singapore has implemented the CLS(MD) scheme, a collaborative effort to enhance medical device cybersecurity.
This article explores the latest updates on the CLS(MD) Sandbox program, its background, key details, and how medical device manufacturers can benefit from participation.

More