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 →
The Bureau of Indian Standards has announced the India BIS website must be included on either the India BIS product label, on the product packaging, or both. India BIS Website... read more →
Please be advised, Mexico Customs is becoming more stringent with Mexico NOM Certificate requirements. The actual importer or distributor as the legal representative on all Mexico NOM Certificates is now... read more →
India’s total medical device market is currently $5.2 Billion USD, and imports are 75% of the total market. India’s medical device market is expected to grow due to increased health... read more →
Supplier's Declaration of Conformity (SDoC) has recently become an optional certification path to the Chinese CCC mark for automotive interior trim parts, door locks and hinges. Previously all CCC approvals... read more →
China CCC has announced the following products originally found in the Fire Product Category will no longer require mandatory China CCC Certification. These products no longer need China CCC Certification,... read more →