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India’s Ministry of Health and Family Welfare released draft guidance on essential principles for safety and performance of medical devices marketed in India. Read More
Grace Fu Palma, founder and CEO of Boston-based China Med Device, LLC, a firm specializing in commercialization and funding for medtech companies entering China, considers CFDA’s new draft guideline for registration of optical coherence tomography devices used in ophthalmology. Read More
New Zealand’s Ministry of Health released new standards that will ensure all medical devices are properly named and identified for clinical and supply chain purposes in the country. Read More
Grace Fu Palma, founder and CEO of Boston-based China Med Device, LLC, a firm specializing in commercialization and funding for medtech companies entering China, considers CFDA’s proposal for exempting certain IVD reagents from clinical trials.Read More
Grace Fu Palma, founder and CEO of Boston-based China Med Device, a firm specializing in commercialization and funding for U.S. medtech companies entering China, offers an update on CFDA’s clinical trial reform.Read More
The U.S. Trade Representative flagged China and India on its latest priority watch list of countries with lax intellectual property protections and counterfeit products, noting special concern for medical devices. Read More
Grace Fu Palma, founder and CEO of Boston-based China Med Device, a firm specializing in commercialization and funding for U.S. medtech companies entering China, offers some tips for submitting Clinical Evaluation Reports in the CFDA registration process.Read More
Australia’s Therapeutic Goods Administration (TGA) is proposing to review products currently classified as Class I medical devices to see if they should be reclassified as consumer goods. Read More
Grace Fu Palma, founder and CEO of Boston-based China Med Device, LLC, a firm specializing in commercialization and funding for medtech companies entering China, explains how medtech companies can save time and expense for medical device registrations in China.Read More