• 2022-06-29 02:30:03

The termination of Thai FDA's "Pre-Submission" resulted in the establishment of a new route to determine product risk classification and medical device grouping via the E-submission system.

• 2022-05-26 13:57:18

PFDA extended the CMDN Requirement of Class B-D Non-Registrable products until March 2023. This will allow continue selling of the affected products in the country using a License to Operate as the requirement. In addition, PFDA shared draft regulations pertaining to the earlier released Abridged Route Evaluation and COVID-19 products using new technologies.

• 2022-04-27 11:34:25

The US FDA is classifying the interoperable automated glycemic controller into class II. Also, the codified language for the interoperable automated glycemic controller is taken as a part of the device to the special control.

• 2022-04-27 11:27:43

In correspondence with the risk-classification implementation for recent period starting from mid-February 2021 onwards, Thailand Food and Drug Administration has ultimately publicized the Guidance on Change Notification for Listing Medical Device, Notified Medical Device and Licensed Medical Device, which has been effective since 1st March 2022.

• 2022-03-25 11:58:47

The US Food and Drug Administration (FDA) has updated several regulations affecting De Novo classification of novel medical devices. The main purpose is to present an objective and balance for the scientific evidence to be the foundation to grant a De Novo request. Also, the De Novo products will serve as future predicate devices for prospective 510(k) registration applications to improve and extend the existing 510(k) database.

• 2022-03-25 11:56:37

Recently, TFDA has announced an update in the Quality Management System (QMS) application required documents for manufacturers in the US, Puerto Rico, or Guam. Considering the establishment inspection timeline, for manufacturers without EIR within 3 years, audit report issued under MDSAP could be provided instead.

• 2022-02-18 09:37:25

The US FDA is planning to issue transition plans for medical devices with Emergency Use Authorizations (EUAs). The EUA measure had previously been implemented in order to increase related necessary medical product supply on the US market.
As the Coronavirus Disease 2019 (COVID-19) pandemic gradually slows down, FDA has published a draft guidance to provide its recommendations to manufacturers, and in order to outline a roadmap for EUA devices to be able to transition after the emergency use declarations are no longer in effect in the future.

• 2022-02-18 09:29:35

Since January 18th, 2022, FDA formally classified the electrocardiograph software for over-the-counter use as class II (special controls).

• 2022-02-18 08:32:17

PFDA released draft document of the updated guidelines for in-vitro diagnostic medical devices (IVD) certification. This new regulation will conform to the risk-based classification of the ASEAN medical device directive (AMDD). A tentative list of registrable IVDs together with a revised set of requirements to register COVID-19 Test Kits was also released on a separate document.

• 2021-12-27 06:18:36

PFDA announced that abridged route for processing of Registration and Notification Applications for Medical Devices will commence starting Nov 25. This aims to increase the efficiency of public access to safe, quality, and effective medical devices