• 2023-01-19 05:55:29

Two regulations for medical devices have been implemented in the month of December 2022. One is a common specification for the groups of products without an intended medical purpose, the other are rules regarding reclassification of groups of certain active products without an intended medical purpose.

• 2023-01-19 05:51:33

This guidance is to assist manufacturers to implement the legal requirements related to the Periodic Safety Update Report (PSUR), which has been introduced in Article 86 of the MDR. This guidance provides the detailed information of the PSUR requirements and the related templates.

• 2023-01-19 05:49:15

It is announced that the MDA amended the terms of the establishment license granted under section 15 of Act 737 in accordance with Act 20's provisions. At least 90 days before the license expires, the establishments must submit an application to the Authority for a renewal.

• 2023-01-19 02:06:31

The Singaporean Health Sciences Authority (HSA) has updated the regulatory guidelines for Laboratory Developed Tests (LDTs) based on the feedback from the stakeholders for the draft that was published for consultation last July 12 - August 12, 2022. The finalized version is coded as GL – 08 R1 with the title of “Regulatory Guidelines for Laboratory Developed Tests (LDTs)”and will be effective on March 1, 2023.

• 2023-01-19 01:28:15

As we are easing into the first quarter of 2023, we are thus simultaneously entering into the last phase of Thai FDA grace period regarding the transition to the risk-classification approach. Thus, Thai FDA has published a summary of the medical device categories on their official website instructing medical device registration via Full CSDT submission and Partial 2 Submission route.

• 2022-12-27 10:11:55

A Quality Management System (QMS) is used by a company or manufacturer as a set of policies, procedures, and processes. It provides a constructive handling and coordination of a business by continual improvements in effectiveness and efficiency. In this article, the QMS requirements for medical device manufacturer, company or organization on different countries will be explored.

• 2022-12-27 08:57:20

The Center for Medical Device Evaluation (CMDE) has issued the “List of Mandatory Standards Applicable to Medical Devices” for applicants to determine the mandatory standards which apply to a specific product.

• 2022-12-27 08:46:16

This guidance is written for AR, manufacturers and other economic operators and provides clarification on relevant requirements under the Regulations.

• 2022-12-27 07:40:22

Indonesia Halal Assurance Agency have issued Decree of Head of BPJPH Regulation Number 133 of 2022 concerning Procedures for Requesting Data Amendment on Halal Certificates. This regulation outlines the types of amendment allowed and the procedures for amendment application in Halal certificates.

• 2022-12-27 07:34:59

With the implementation of SATUSEHAT (the Indonesia Health System), the MoH are starting to build a Pharmaceutical and Medical Device Dictionary that will contribute to the interoperability between digital health apps and supply chain information of drugs and medical devices.