• 2020-02-13 06:23:56

MDA has released a Circular Letter at the end of May 2018 as a reminder notice on the complete enforcement of requirements for registration of medical device under Section 5 of Medical Device Act 2012 (Act 737), whereby no medical device can be allowed to be imported, exported or marketed in Malaysia unless it has been registered with MDA, according to this Act.

• 2020-02-13 06:22:55

The number of registered medical devices which become obsolete and get discontinued and become orphaned are increasing in Malaysia with no policy in place to control them to meet requirements in accordance with the purposes of this Act.

• 2020-02-13 06:16:25

According to Section 5(1) Act 737, all medical devices to be imported, exported or placed in the market in Malaysia must be registered under this Act. However, considering that export only medical devices do not pose any risks to the public because they do not enter the Malaysian market,

• 2020-02-13 06:14:29

Following the Executive Presentation on the New Fee Structure and Modernization Initiatives held last June 28-29, a draft of the New Schedule of fees has been posted which aims to notify all stakeholders concerning the significant increase in charges associated with medical registration,

• 2020-02-13 06:13:18

Health Sciences Authority announces changes to the regulatory process for medical devices, including faster market access for lower risk devices, clearer regulatory controls for De novo device and high risk device, strengthen Post-market measures. 

• 2020-02-13 06:11:12

In order for clients to understand the key factors affecting the registration situation of medical devices in China in the last three years (2015-2017), Qualtech has provided an overview and analysis of the medical device registration data (as provided in the following sections of this article),

• 2020-02-13 06:08:28

This month’s updates include the"Revision of Regulations on the Supervision and Administration of Medical Devices", “the Principles of Clinical Trial Inspection”, “a New Catalogue of Medical Devices to Be Exempted from Clinical Trials” among others. All information you need to know has been put in a nutshell:

• 2020-02-14 04:21:46

A research conducted by BMI Espicom showed that the scale of the global medical device market is expected to reach US$38.91 billion in 2019, of which Japan has the world’s second largest medical device market, second to United States. Global medical equipment manufacturers in addition to Europe and the United States well-known manufacturers (GE, Medtronic, Johnson & Johnson, etc.),

• 2020-02-14 04:20:17

China National Drug Administration (CNDA) has revised the special approval procedures for innovative medical devices issued in 2014 to respond to current state. Drafts of the revision were released in early May and is currently open for public comments. This revision will be expected to take effect on October 1, 2018.

• 2020-02-14 04:19:20

In accordance with the requirements set forth in the "Standards management of medical equipment" and the "Management standard for revision of medical equipment standard system," the CNDA has initiated the FY 2018 - The Revision Plan of the Medical Device Standards last May 15.