• 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 06:21:59

Medical devices to be registered in Malaysia must first undergo conformity assessment with a Conformity Assessment Body, to demonstrate its conformity to the requirements of medical device law. In regards to this, currently there are conformity assessment service with good quality and also comparable to global assessments or test carried out by local laboratories.

• 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 06:15:29

All concerned Industry/Stakeholders were invited to attend the FDA Executive Presentation on New Fee Structure and Modernization scheduled last June 28-29 which was held at the Philippine International Convention Center, Pasay City. Based on the informal talks between Qualtech and PFDA,

• 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 06:12:14

Taiwan Food and Drug Administration(TFDA) is organizing an upcoming seminar in end of July (July 20th, 2018) in Taoyuan (Taiwan), and Qualtech has been invited to share our GCP experience in China. This seminar will discuss the GCP inspection of medical devices in various oversea countries and how to conduct a multicenter clinical trial in various countries.