• 2020-02-14 15:20:15

India's central medical device regulator, the Central Drugs Standards Control Organization (CDSCO) published, on November 1, 2017, a revised risk classification of medical devices and IVDs on the basis of their intended use. This is an extremely important development for the medical device and IVD industry because from January 1, 2018 onwards,

• 2020-02-15 06:24:19

The purpose is to amend the clauses in the Supervision and Administration Regulation which are in conflict with the clauses of the Innovation Opinion, and to consummate the relevant regulations.

• 2020-02-15 06:21:59

In order to improve the design of clinical trials of medical devices in the country, the Center for Medical Device Evaluation (CMDE) drafted the guidelines for the design of clinical trials of medical devices, and asked for the public’s opinion.       

• 2020-02-15 06:18:22

On November 1st of 2017, the Medical Device Authority (MDA) released the Draft of a new Guidance Document on the Import and/or Supply of Unregistered Medical Devices for The Purpose Of Demonstration for Marketing or Education. This Guidance Document came just in time to answer foreign manufacturers and local distributors’ concerns on whether unregistered medical devices are allowed to be imported into Malaysia for non-commercial purposes, for a specified timeline.

• 2020-02-15 06:17:38

On October 9, 2017, Medical Device Authority (MDA) Malaysia released a Second Edition of the Guidance Document on Change Notification for Registered Medical Device. This GD serves a great purpose in informing the stakeholders on the categories of changes, notification process and relevant requirements for applying for a change notification in Malaysia.

• 2020-02-15 06:31:28

HSA has finalized the Guidelines for Telehealth Products. Telehealth products refer to "instruments, apparatus, machines or software involved in the provision of healthcare services over physically separate environments via information communication technologies."

• 2020-02-15 06:29:08

Malaysia’s healthcare system consists of two tiers: a state-owned universal healthcare system for national citizens runs alongside a private sector that serves international patients.  Due to projected demographic shifts – chiefly Malaysia’s ageing population, increasing life expectancy and the growth of non-communicable diseases – demand for medical device is expected to grow.

• 2020-02-15 08:19:45

More and more regulatory had been set up and released in ASEAN countries recently.

• 2020-02-15 07:57:54

Association of Southeast Asian Nations (ASEAN) is composed of 10 countries in Southeast Asia. It’s the market with good potential for someone who would like to build a stance in the market of medical devices.

• 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.