• 2020-10-29 05:46:11

Qualtech has started providing regulatory services for medical device manufacturers who aim for the Japanese market. Taking this opportunity, we would like to provide a brief introduction of what Japanese regulation requires for foreign manufacturers to sell their products in its market.

• 2020-10-21 02:06:33

CDSCO has issued draft of new risk-based classification lists for previously non-notified general and IVD medical devices, in order to clarify regulatory pathways and requirements.

• 2020-10-21 01:59:48

Malaysia Medical Device Authority (MDA) published a new circular letter on the policy implementation and enforcement for the refurbishment of medical device and effective immediately. The policy decision to ensure the safety and effectiveness of the refurbished medical devices itself.

• 2020-10-19 09:48:24

Food and Drug Administration has announced sets of documentation required for Licensed Medical Device Manufacturing / Import License Renewal and Notified Medical Device Manufacturing / Import License Renewal that will expire in December 31st, 2020.

• 2020-09-15 08:58:35

Thailand’s Ministry of Public Health has announced the medical devices that are exempted form compliance with certain control measures under Section 6 (18) of the Medical Device Act B.E. 2551.

• 2020-09-15 08:54:58

Ministry of Public Health has made an announcement regarding the Declaration Form for Importer to declare when import all the listed medical device that comply with the standards in 2020.

• 2020-09-15 08:44:25

Thailand’s Ministry of Public Health has announced a set of medical device definition for manufacturers and importers to follow when registering their medical device according to risk-based classification, to gradually endorse the transition of Thailand away from policy-based classification.

• 2020-09-15 06:53:41

Ministry of Public Health has made 2 additional announcements regarding the Standards of Medical Device that manufacturer or importer must comply to in 2020.

• 2020-08-13 09:07:56

Covid-19 pandemic has changed the landscape of the medical device markets drastically. In this article, we explore the shifts in supply and demand and bring up an overview of the key areas that have either been positively or negatively impacted.

• 2020-08-13 02:35:55

TFDA is now collecting comments and suggestions for the drafting of “Regulations Governing Delegation or Commission of Medical Devices Test” (collecting deadline: 2020/09/07). This article presents a closer look of this upcoming regulation.