• 2022-09-27 08:40:58

Matters concerning the filing of Class I medical devices (including Class I IVDs) are announced. The relevant documents are attached as well.

• 2022-09-27 08:26:27

MDCG 2022-13 aims to provide guidance to the authorities responsible for notified bodies and joint assessment teams when conducting assessments of conformity assessments bodies and re-assessments of notified bodies.

• 2022-09-27 08:23:11

A pilot run for the new requirement on the procurement of medical devices by the Department of Health will be implemented with effect from 1st October 2022. Under the pilot run, medical devices purchased by the Department of Health should preferably be listed under MDACS.

• 2022-09-27 07:58:07

Effective since 6th July 2022, Indonesia’s Ministry of Health has issued Ministry of Health Decree number HK.01.07/MENKES/1258/2022 concerning Substitution of Imported Medical Devices with Domestic Medical Devices in the Electronic Catalog / e-Katalog of the Health Sector that implement the freeze/ unfreeze mechanisms.

• 2022-09-27 07:47:09

PFDA held a public hearing about updated draft for the In-vitro diagnostic (IVD) medical device regulation and registration in the Philippines including discussion on transition period and implementation timeline.

• 2022-09-27 07:39:04

In order for Thai FDA’s quality control to conquer approval certificate issuance ratio, Thai FDA respectively announced a new E-Submission procedures governing Listing Medical Device, Notified Medical Device, and Licensed Medical Device applications (with exemption of class 1 auto approval), which has been effective since 1st August 2022.

• 2022-09-27 07:17:48

Utilization of Remote Regulatory Assessments (RRA) as a critical examination of an FDA-regulated establishment and/or its records. FDA has published the draft guidance to let more people understand its value and what FDA expectations for RRA are.

• 2022-09-27 07:07:49

The Food and Drug Administration (FDA) established a new regulatory category for over-the-counter (OTC) hearing aids. The new policy will redefine OTC hearing aids and change the current rules as well as modify the obsolete old rules. FDA believes this method will ensure the OTC hearing aids with innovative technology provide reasonable safety and effectiveness, while promoting public health.

• 2022-09-27 06:12:22

The Vietnam Ministry of Health released Circular No. 05/2022/TT-BYT on August 1, 2022, detailing a number of articles of the Government's Decree No. 98/2021/ND-CP dated November 8, 2021, on the management of medical devices.

• 2022-08-31 05:37:18

MDCG 2022-12 provides guidance to Member States and other relevant parties on the application of certain IVDR provisions during the absence of Eudamed. This guidance intends to describe harmonized administrative practices and alternative technical solutions for the exchange of information until Eudamed becomes fully functional.