Asia Actual Summit in Indonesia
April 23rd to 27th, 2024, Asia Actual Indonesia hosts Asia Actual USA, Singapore, China, Vietnam, Philippines, and Thailand, for a Summit.
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Medical Device Risk Classification Problems in Vietnam
According to a report published on May 7th, 2024, contractors have been apprehended misrepresenting IVD and Medical Device risk classification to participate in bidding parties.
Innovative Medical Device Registration in Japan
In 2019, Japan’s Ministry of Health, Labor and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA) introduced a innovative device registration designation system, called Sakigake, which is meant to streamline the regulatory pathway for qualifying medical products.
Medical Device Consultation in Japan
Medical device consultation in Japan is a very involved but essential process in registering a medical device. A significant part of the regulatory process in Japan is consultation meetings with the Pharmaceuticals and Medical Devices Agency (PMDA).
Vietnam’s MoH Updates Class C and D Application Requirements
Per Decree 07/2022, the application requirements for new Class C and D applications submitted to the Vietnamese Ministry of Health (MoH) after January 1, 2024 will need to be in ASEAN Common Submission Dossier Template (CSDT) format, with the addition of a Vietnamese IFU.
New Plastic Waste (PWM) Rules Affect Medical Device Importers in India
India’s Pollution Control Board (CPCB) has issued an update on plastic packaging and Plastic Waste Management (PWM) requiring importers quantify the type of plastics being imported through a brief registration process.
Vietnam Extends Validity of Medical Device Import Licenses
On March 3rd, 2023, the Deputy Prime Minister of Vietnam, Tran Hong Ha, signed Decree No. 07/2023/ND-CP (Decree 07/2023), which automatically extended the validity of import licenses to December 31, 2024.
Vietnam’s DMEC Provides Update on Issuance of C/D Licenses
On September 14, 2022, the DMEC held a seminar to update the medical device industry on the issuance of Class C and D MA Licenses.
Vietnam’s MOH Holds Conference on Price Declaration
The conference was held to provide clarity to the Price Declaration process and announce the establishment of a new online portal for license holders to declare prices. This comes as many provincial health services, including Ninh Binh and Dak Nong, have not been able to purchase medical products since January 1, 2022.
Vietnam Requires Resubmission of Many Medical Device Registration Applications
All unapproved Class B, C and D MA License applications have been returned for resubmission for compliance to the new requirements.