• 2020-05-06 06:04:19

Thai FDA is highly concerned with the health and the well-being of the people abrupt from the situation of PM.2.5 in Thailand. Respectively, the “Letter of Notification: Registration of Importer Establishment License and Registration of Medical Mask for Special Circumstance” was announced.

• 2020-02-12 14:21:58

Last August, NMPA has issued a draft entitled “Measures for the Supervision and Administration of the Local Authorization Agent for Imported Medical Device” in order to ensure the safety and effectiveness thereof. The draft was also aimed at regulating the behavior of local authorized agents of imported medical devices.

• 2020-02-12 15:04:32

In Medical Device Act 2012 (Act 737) of Malaysia, there is no specific provision for medical devices imported/exported from/to countries without diplomatic ties with Malaysia, such as Israel. Malaysia has not acknowledged Israel as an independent sovereign state.

• 2020-02-12 15:00:06

Slight revision on guidance documents about Singapore Standards and Medical devices for exhibition were added last July 2018.

• 2020-02-12 14:58:58

In order to unify the management of medical device import license, MoH informed and stopped receiving the contents of request for adjustment of import license which has a validity period until Dec 31st, 2017 granted in accordance to Circular No. 30/2015/TT-BYT.

• 2020-02-12 16:03:14

The National Telecommunications Commission of Philippines (NTC) regulates Radio Communication Equipment (RCE) and Customer Premises Equipment (CPE) under Section 1A of the Republic Act No. 3846 as amended. Specific regulations that cover for these devices are hereby summarized:

• 2020-02-12 16:00:39

The list of medical equipment defined with HS codes issued together with this Circular is the basis for organizations and individuals to make customs declarations when exporting or importing medical equipment into Vietnam.

• 2020-02-14 03:56:57

MDCO has revised guidance document related to Importer Listing in Hong Kong, that are GN-07 Guidance Notes for Listing of Importers of Medical Devices, COP-04 Code of Practice for Listed Importers of Medical Devices, and Application for Inclusion on the List of Importers/ Distributors (Form MD-IP+D). This new guidance will be fully implemented start from June 1st 2018.

• 2020-02-13 06:11:12

In order for clients to understand the key factors affecting the registration situation of medical devices in China in the last three years (2015-2017), Qualtech has provided an overview and analysis of the medical device registration data (as provided in the following sections of this article),

• 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.