top of page
Search


Vietnam: MOH has issued Circulars 05/2022/TT-BYT on new update for Class C and D Applications
Vietnam MOH has issued Circulars 05/2022/TT-BYT which is a detail guides of some articles in Decree 98. We would like to update to you...

ARQon
Aug 4, 20221 min read


Singapore: New Dental laboratory requirements in Singapore (No QMS certification required for Class
Local dental laboratories have experience with manufacturing custom-made dental MDs Locally manufactured custom-made dental MDs - have...

ARQon
Jul 15, 20221 min read


Singapore: Provisional authorization pathway open to devices for single-use respirators
With the outbreak of the COVID-19 pandemic, there has been a high demand and critical shortage of respirators all around the world....

ARQon
Jul 15, 20223 min read


Singapore: Revision of GN-21 on impact related to CE marking
There have been some changes in the Singapore Health Science Authority (HSA) regulations to promote quicker access to the registration of...

ARQon
Jul 15, 20222 min read


Vietnam: Declaration of Pricing for medical devices (effective 1 April 2022)
“After a very active period of implementation, the Ministry of Health has built an electronic portal to declare and publicize prices for...

ARQon
Jul 15, 20221 min read


Philippines: Requirement of CMDR and CMDN start period amended from 1 April 2022 to 1 April 2023
Section V (1) of FC No. 2021-002-A is hereby amended as follows: The date when all Class B, C, and D medical devices that are already in...

ARQon
Jul 15, 20221 min read


Philippines: FDA publishes new draft for IVD regulators (Jan 2022)
In January 2022, the Philippines FDA published a new draft regulation on IVD market authorization. The draft was open for public review...

ARQon
Jul 15, 20221 min read


Malaysia: Guideline Re-registration of registered medical device
Section 5 (1) of Medical Device Act 2012 (Act 737) requires a medical device to be certified under the Act before it can be ferried,...

ARQon
Jun 24, 20222 min read


Singapore: HSA provides risk classification tool as guidance on MD grouping
Effective from 2022, HSA would no longer accept service request from manufacturers requiring affirmation of their classification and...

ARQon
Jun 24, 20221 min read


India: More medical device testing facilities have been added to DCGI
Providing better assistance in obtaining medical device or in vitro diagnostic device (IVD) testing to be done in an easier and smoother...

ARQon
Jun 24, 20222 min read


US: FDA has launched a Voluntary Improvement Program to improve medical device quality
On May 5, 2022, US FDA has published and issued a draft guidance, “Promoting Improvements in Medical Devices: Involvement in FDA...

ARQon
Jun 24, 20222 min read


Brazil: ANVISA repeals coronavirus-related medical device laws
With the decreasing numbers of infections in the Public Health Emergency (PHE), the Brazilian Medical Device Market Regulator ANVISA...

ARQon
Jun 24, 20221 min read


Thailand: Updated Medical Device Application Review Timeline
The review timeline for the submission of medical device applications through e-submission portal has been newly revised and released by...

ARQon
Jun 24, 20221 min read


Taiwan: FDA launched online submission of application
The Taiwan Food and Drug Administration (FDA) launched the Premarket E-Submission Portal on 21 January 2022 to simplify the submission...

ARQon
Jun 24, 20221 min read


Malaysia: New Guidelines for Registration of Covid 19 IVD Covid Test Kits
The Medical Device Centralized Online Application System (MeDc@St.2.0) will be used for submission of all registration applications....

ARQon
Jun 24, 20221 min read


Singapore: HSA review fees to be raised in July 2022
Singapore Health Science Authority (HSA) has announced to increase fees averaging 3%, with a minimum increase of $1 and capped at $200...

ARQon
Jun 24, 20221 min read


China: Implementation of Electrical Safety Standards for Medical Devices
In February of 2020, China released a new update on all the medical electrical equipment with new safety standards in China-specific that...

ARQon
Jun 24, 20222 min read


China: Notice on the matters of Implementing the Good Clinical Trials Practice for Medical Devices
The Medical Device Good Clinical Practice (GCP) has been newly revised and announced by the National Medical Products Administration...

ARQon
Jun 24, 20223 min read


China: Public Announcement on adjusting part content of the Classification Catalogue of Medical Devi
In March of 2022, China’s National Medical Products Administration (NMPA) released an announcement that there will be an adjustment to...

ARQon
May 6, 20222 min read


India: Import License for Custom Clearance
The Central Drugs Standard Control Organisation (CDSCO) under Directorate General of Health Services, Ministry of Health & Family...

ARQon
May 6, 20222 min read
bottom of page
.png)