MIC has issued the circular, 10/2023/TT-BTTTT, which postpone application of partial/full implementation of some technical regulations in circular No. 04/2023/TT-BTTTT dated May 31 of 2023. Relevant enterprises are allowed to apply for Certificate of conformity in accordance with 04/2023/TT-BTTTT (with full technical regulations) or 10/2023/TT-BTTTT (without postponed technical regulations). At ..

CPSO has issued a circular, CPSO-070923-11, to clarify the testing and certification requirements for AC adaptors which can deliver more than 100W of power (>100W), under IEC 62368-1 as follows: 1. Requirements for AC Adaptors tested to IEC 62368-1:2018 and earlier a. Clause 6.6. of IEC 62368 (Ed. 3.0 and earlier) only allows for AC adaptors that can deliver >100W to connected equipment if the c..

On July 21 of 2023, the order “The Bolts, Nuts and Fasteners (Quality Control) Order, 2023” has been issued. The scope of the order and applicable standards are as follows: Goods or articles Indian Standard Title of Indian Standard Bots, Nuts and Fasteners 1363 (Part 1):2019 Hexagon Head Bolts, Screws and Nuts of product Garde C Hexagon Head Bolts (Size Ragne M5 to M64) 1363 (Part 2):2018 Hexago..

On August 29, 2023, the Medicines and Healthcare Products Regulatory Agency (MHRA) announced that they had designated three new UK Approved Bodies, almost doubling the UK’s current capacity to certify medical devices. Under the current UK legislation, before a manufacturer can place a UKCA-marked medical device on the market in England, Wales and Scotland, they must secure UKCA marking from a UK..

ANVISA, Brazil's medical device regulator, issued RDC No. 810/2023 to amend Article 60 of RDC No. 751/2022: Declaration and Registration of Medical Devices, the amendment effective August 18, 2023. The revised content allows the import of medical devices and accessories if the manufacturing date is earlier than the date of declaration or registration. Note that the period between the manufacturi..

The Cosmetics Regulation Modernization Act (MoCRA) is important to the chapter VI of the Federal Food, Drugs and Cosmetics Act (FDCA) and adds new information (GMP, safety proof, critical adverse event reporting, facility registration, product registration, additional labeling marks, record keeping, etc.). It also gives the FDA the authority to order compulsory recalls. MoCRA's facility registra..

With the development of information and communication technology, the number of wired and wireless communication medical devices is increasing. As a result, cases of cybersecurity threats such as hacking and information leakage are steadily increasing. For this reason, the application of cybersecurity in medical devices has been strengthened because it can directly harm patient life. Medical dev..

Currently, Taiwan only requires product registration for general cosmetics, and regulations on product registration, product information file (PIF) preparation and preservation, and GMP acquisition will be applied to all items from July 2026. First, the cosmetics classification in Taiwan is as follows. - General cosmetics: basic cosmetics (skin, lotion, essence, cream, etc.), hair products (sham..

The cosmetics market was sluggish during the pandemic, but is now gradually recovering, showing a positive outlook. Brazil has the world's fourth-largest cosmetics market. In order to enter the Brazilian beauty market, registration of cosmetics with Brazil's ANVISA is essential. Brazilian cosmetics are classified into Class I and Class II according to risk of cosmetics. Classification Descriptio..

The Ministry of Food and Drug Safety has established an integrated guideline for authorization, certification, and examination of wound dressing (a guide to civil petitioners). The wound dressing material is manufactured in various forms, such as item shape, sheet shape, liquid shape, powder shape, etc., and is a medical device used to absorb exudate from wounds, bleed or lose body fluid, and pr..