• 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.

• 2020-02-14 14:48:09

This means that the Marketing Authorization License for Class B, C, and D medical devices will be delayed for one year from the original date set forth under Decree 36. Thus, with the official release of the Dispatch 7165 in Vietnam, some specific interim regulations are as follows:

• 2020-02-14 15:21:19

Head of Indonesia Ministry of Health, Nila Moeloek, said that the Ministry is trying to accelerate medical device and household products licensing by developing Single Submission and Indonesia Single Risk Management (ISRM) system. By using this system, hope the time consumed for licensing process can be accelerated,

• 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,