For manufacturers who are starting to implement the new hazard based IEC 62368-1 standard for their products, they may soon become aware that IEC/EN 62368-3 (an offshoot standard) is emerging... read more →
As everyone is aware, COVID-19 has affected many countries, including India. Due to India’s three-week lockdown, the Bureau of Indian Standards has issued the following temporary measures in response: For... read more →
The Indian health ministry has announced that all medical devices must meet specific safety and quality standards before they are introduced in the Indian market beginning April 1st, 2020. ... read more →
Beginning March 1st, 2020, RoHS certification will be mandatory for certain products to be placed on the market in Russia or countries within the Customs Union including Belarus, Armenia, Kazakhstan... read more →
The Indian government recently published a list of proposed items to be covered under phase IV of "Electronics and IT Goods (Requirement of Compulsory Registration) Order, 2012.” Below is the proposed list... read more →
The European Union Medical Device Regulation (MDR – 2017/745) will be replacing the existing Medical Device Directive (MDD) in May 2020. Compared to the MDD, the MDR has implemented stricter... read more →
It has been roughly a year since MEITY of the Indian government announced that a change to the BIS (CRS) surveillance process was impending. We now have reason to believe... read more →
On October 21st, 2019, Indonesia SDPPI, or the Indonesia Directorate General of Resources and Equipment for Post and Information Technology announced the following: Telecommunication devices with Wavelength Division Multiplexing or... read more →
On October 17, 2019, Chinese government department SAMR published announcement No. 44, 2019, which includes major changes to certification requirements for automotive components. Moving forward, some automotive components remain under... read more →
If the following conditions apply to you: Spend over $100K annually for Regulatory Product Compliance (Homologation for short), and Sell products into four or more markets requiring certification; You need... read more →