• 2020-02-14 07:32:41

The Council decides to suspend the implementation of Clause 11 of the Medical Device Registration and Management in the Hainan tourism area. In order to support this suspension, CNDA has released a temporary Order, entitled “The Supervision Regulation of Emergency Medical Devices in Hainan International Tourism Area”. The scope of this Order includes all medical devices that are urgently needed for clinical purposes, operation conditions, and a

• 2020-02-14 07:32:02

The new medical device rule “MDR 2017, India” has come into effect from January 2018. In line with that, the CDSCO (Central Drug Standard Control Organization) has recently been releasing guidance documents,

• 2020-02-14 07:43:27

Following a list new regulations and requirements released in March 2018, MDA has issued a new guidance document which specifies requirement on notification for importation and/or supply of medical devices intended solely for the purpose of demonstration for marketing or for the purpose of education.

• 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.

• 2020-02-14 07:49:21

This major announcement was made by the Department’s Halal Hub Division director, Datuk Sirajuddin Suhaimee in early February 2018, who said the certification, drafted together with the Department of Standards Malaysia, was now at the final stage of public feedback.

• 2020-02-14 07:47:14

In order to create favorable conditions for importers, the customs office shall handle the goods release procedures for special-purpose medical equipment and instruments, shall apply 5% VAT on the basis of written commitments and shall take responsibility before the law for the declaration.

• 2020-02-14 07:54:36

On February 6, 2018, Medical Device Authority (MDA) of Malaysia released a Second Edition of the Guidance Document on Requirements for Labelling of Medical Devices. This GD serves a great purpose in informing the stakeholders on the additional requirements and content to be included in medical device labelling which are to be placed in Malaysia market or be exported.

• 2020-02-14 14:54:42

In order to enhance the inspection of imported drugs and medical devices, China Food and Drug Administration (CFDA) has issued “Draft of Regulations for The Administration of Overseas Inspection of Drug and Medical Devices”. It is currently looking for public comments until January 24, 2018.

• 2020-02-14 14:53:03

Malaysian lawmakers take medical device related issues pretty seriously, starting with the introduction of the Medical Device Act 2012 (Act 737) and Medical Device Regulations 2012. A faulty pacemaker or even a leaking catheter are the last things patients need to worry about as they may pose various levels of threat to their lives.

• 2020-02-14 14:50:04

On December 15, 2017 Philippine Food and Drug Administration (FDA) announced some changes in the Application of Variation of Certificate of Product Registration for Medical Devices.