• 2020-02-14 03:49:35

In the other word, a marketing authorization license of medical devices containing mercury that has an expiry date later than December 31, 2018 will be automatically not valid after that date and the owner of a marketing authorization license must surrender the marketing authorization back to the Ministry of Health of Indonesia cq.

• 2020-02-13 06:24:58

According to rule 19 of the Medical Device Rules 2017, the central government may establish “Central Medical Devices Testing Laboratories” for the purpose of

• 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.),