Tag Archive for: medical device regulations

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.

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.

India Changes Medical Device Application Processing System

On January 1, 2024, India’s CDSCO released a notice announcing the roll-out of the NSWS.

India’s Class C and D Import License Enforcement Deadline Fast-Approaching

On April 1, 2024, the Central Drugs Standard Control Organization’s (CDSCO) grace period for Non-Regulatory Class C and D medical devices in India comes to a close.

India Issues Draft Notification for Exempting Certain Class A Medical Devices

The Indian Ministry of Health and Family Welfare (Department of Health and Family Welfare) issued the draft Notification G.S.R. 710(E) on 20 September, 2022 that, if formalized, would exempt Class A non-measuring and non-sterile medical devices.

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.

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.

India Issues New Sales License Requirement for Medical Devices

On September 30th, 2022, the Indian Ministry of Health and Family Welfare (MOHFW) issued GSR 754(E) announcing new sales license requirements for entities importing and distributing formerly non-notified medical devices.

India Grants Import License Grace Period for Class A/B Devices

Released on September 30, 2022, the Central Drugs Standard Control Organisation (CDSCO) issued Circular File No. 29/Misc/03/2022-DC (257) providing an Import License grace period to all Non-Regulatory Class A and B medical devices.

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.