• 2020-11-27 02:14:19

From October 19, 2020 to August 31, 2021, China will have a pilot run of electronic registration certificates issuance for medical devices. It will entail newly approved pre-market domestic Class III, foreign Class II and Class III medical devices.

• 2020-11-27 02:07:10

This announcement applies to all registrants of foreign Class II and Class III medical devices that have been registered in China, through foreign manufacturers established in China.

• 2020-11-26 03:47:29

In 2020, National Public Procurement Agency (in Indonesia known as LKPP) has opened E-katalog registration for domestic medical device products and several medical products for handling Covid-19. Due to the Covid-19 pandemic, there are several stages in the E-katalog registration process which is carried out online, namely verification / clarification process. However, the price negotiation stage is still carried out face to face. There is also a possibility that e-katalog registration for imported medical products will be opened around this year.

• 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.