A threat is currently hanging over the Swiss medical device industry, which is heavily reliant on trade with the EU. Upcoming changes to the CE marking regime will have the effect of making the mutual recognition agreement (MRA) obsolete. This currently allows Switzerland to enjoy unrestricted access to the medical device market in the 27 member states. Up until now, this bilateral agreement has regulated trade between Switzerland and the EU.
The U.S. Senate Finance Committee held the first of its two hearings on the supply chains for a variety of products vital to the response to the COVID-19 pandemic. While electoral politics were on full display during the hearing, a recurrent theme was the need to bring supply chains back to the Western Hemisphere as a solution to the fraudulent products shipped to the U.S. from Hong Kong and China.
HONG KONG – India has been slowly easing restrictions on the export of its med-tech products, giving hope to domestic manufacturers looking to meet global demand for their output. “We are pleased to share that many of the routine IVD diagnostic kits falling under HSN code 3822 have been removed from export restrictions and a few specific items related to COVID-19 testing retained,” Rajiv Nath, the forum coordinator for the Association of Indian Medical Device Industry (AIMED), told BioWorld recently.
HONG KONG – India has lifted some restrictions on the export of its medical supplies in light of the global battle against the COVID-19 novel coronavirus. Last month, Indian authorities started restricting the export of certain active pharmaceutical ingredients (APIs) and the formulations based on some specific APIs.
HONG KONG and BEIJING – Not just multinational players but domestic Chinese pharmaceutical companies are poised to benefit from China’s promise under a phase one trade deal with the U.S. to better protect intellectual property (IP), even if question marks remain around how the deal will be enforced. The move is in line with China's ambition to strengthen IP rights protection and upgrade the approach to innovation of its pharmaceutical and biotech industries.
Time will tell whether what the Trump administration is calling a “historic” and “landmark” trade agreement with China will better enable drug and device companies to more fairly compete in the Chinese market without having to sacrifice their intellectual property (IP) and technology.
Time will tell whether what the Trump administration is calling a “historic” and “landmark” trade agreement with China will better enable drug and device companies to more fairly compete in the Chinese market without having to sacrifice their intellectual property (IP) and technology.
KARACHI, Pakistan – Hit by international sanctions, medical device manufacturers in Iran now are looking to get their products out to the world with a little help from neighbor and friend Pakistan. This year, Iran’s med-tech makers have taken their first steps toward finding a new route for their products that goes beyond its neighbors.
The U.S. FDA draft guidance for appeals for denial of certificates for export indicated that the scope was limited to devices exported from physical locations in the U.S. This provision appears in the final guidance as well – despite arguments that it flies against the text of the Food and Drug Administration Reauthorization Act of 2017 (FDARA)
BOGOTA, Colombia – During the past few years, the Dominican Republic has become one of the leading medical device suppliers to the U.S. It has positioned itself as the Latin American country with the highest export value of medical and surgical instruments worldwide. This year, it aims to expand its med-tech exports at a 7% rate.
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