It has obligations such as record keeping, reporting and handling of products through the following four corporations designated as Economic Operators under the European Medical Device Regulations (EU MDR). Manufacturers Importers Distributors Authorized representatives However, manufacturers that are not located in the EU require authorized representatives. As such, MDCG 2019-5 rev.1 outlines t..

The label of the medical device should be marked on the container, exterior, or external packaging. It should be in a location where consumers can easily find it, and should not fall off easily. Medical device labels are mandatory, and each country has its own obligations. We will briefly explain the labeling requirements in Korea, the US and Europe. 1. Korea (1) Trade name and address of manufa..

Medical device quality system certification is called Good Manufacturing Practice (GMP). GMP certification, commonly referred to as ISO 13485 certification, is a process managed by a medical device manufacturer over the life cycle of the medical device, from the development of the device to the post-production stage, including disposal. There are many countries that can be licensed with ISO 1348..

The Ministry of Food and Drug Safety (Medical Device Policy Division) has prepared some amendments to the Enforcement Rules of the Medical Device Act to improve and compensate for some deficiencies in the operation of the current system, such as preparing grounds for reporting first and second-class medical device supply. Please refer to the link below for details on some amendments to the Enfor..

Updated good manufacturing practice (GMP) requirements for medical devices on the Mexican market have taken effect as of June 20, 2023. The latest version of Mexican Official Standard NOM-241-SSA1-2021, Good manufacturing practices for medical devices (hereafter NOM-241), published December 20, 2021, and coming into effect on June 20, 2023, establishes the minimum requirements for medical device..

The purpose of renewing medical device items periodically is to ensure the safety and effectiveness of products. According to the revision of the Medical Device Act, manufacturers and importers must extend the validity period to continue to manufacture and import products after the end of the specified validity period. The Ministry of Food and Drug Safety (Medical Device Safety Evaluation Divisi..

The Swissmedic guidance mandates the inclusion of CH-REP (Swiss Responsible Person) information on the labels of Class I MDR devices starting from 31st July 2023. The inclusion of CH-REP information on the labels of Class I MDR devices is now mandatory as per the guidelines provided by Swissmedic. This regulation aims to ensure transparency and accountability in the Swiss market and strengthen t..

From October 2023 onwards, the mandatory registration of Class C and D medical devices in India will require conformance with the Quality Management System (QMS) requirements, as per the Indian Medical Device Rules (IMDR) 2017. n India, medical device registration and regulations are governed by the Central Drugs Standard Control Organization (CDSCO), which issued the IMDR in 2017. Compliance wi..

Malaysia's MDA will be able to download electronic medical device registration certificates from May 2, 2023. Once the application is completed and the registration fee is paid, it can be downloaded from the MeDC@St2.0+ system. Electronic medical device registration certificates can be used to import medical devices or to launch them in the Malaysian market, The transition period to the former i..

In a virtual meeting held June 19, 2023, the Thai Food and Drug Administration (TFDA) discussed several measures aimed at enhancing the management of medical device registration applications. Optional Screening Process Starting from July 1, 2023, the screening process for medical device registration applications will become optional. Applicants will have the choice to undergo the screening proce..