China’s top administrative authority, the PRC State Council, issued the new regulation of Supervision and Administration of Medical Devices (or State Council Order Number 739) on February 9, 2021.
The Pharmaceutical and Medical Devices Agency (PMDA) is an independent administrative institution responsible for ensuring the safety, efficacy and quality of pharmaceuticals and medical devices in Japan. One of the major functions of this agency is to review marketing applications of medical devices and in vitro diagnostic (IVD) products. In recent years, the PMDA has provided sponsors an annual report on review performance to assist in understanding the predictability and associated timelines for regulatory approval.
TOLEDO, OHIO (BUSINESSWIRE) — January 7, 2019 — NAMSA®, the world’s only Medical Research Organization (MRO) that accelerates medical device development through integrated laboratory testing, clinical research …
In order to implement relevant requirements in the “Opinions on Deepening the Reform of the Examination and Approval System and Encouraging the Innovation of Drug Medical Devices,” the Chinese State Drug Administration issued the “Notice on the Implementation of Electronic Declaration of Medical Device Registration” (No. 46 of 2019) on May 31, 2019. Simultaneously, the … Continued
SHANGHAI, CHINA – (BUSINESS WIRE) – NAMSA, the world’s only Medical Research Organization (MRO) that accelerates medical device development through integrated laboratory, clinical research and regulatory consulting services, is excited to announce the launch of its newly-developed website to serve as a new resource for Asia-Pacific (APAC) medical device sponsors. The introduction of this highly-anticipated website is … Continued
On 31 January 2018, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) released Cabinet Order No. 24 which sets forth changes for medical device and IVD registration user fees. These changes, which include increases from 8 to 15 percent, are effective 01 April 2018. To assist medical device manufacturers in assessing the impact of these changes … Continued
On January 11, 2018, the China Food and Drug Administration (CFDA) issued “Technical Guidelines for the Acceptance of Overseas Clinical Trial Data of Medical Devices.” These guidelines pertain to the acceptance of overseas clinical trial and evaluation data that are submitted by medical device and In Vitro Diagnostics (IVD) registration applicants in China. It is … Continued
On October 31, 2017, the China Food and Drug Administration (CFDA) issued the “Amendments to the Regulations on the Supervision and Administration of Medical Devices” Exposure Draft which aims to strengthen medical device technology reviews and approval systems. This draft guidance also further encourages medical technology innovation in light of the original guidance on “Opinions … Continued
Medical device products throughout the globe are characteristically classified by their specific risk level or category. This is no different in Japan, the world’s third largest medical device marketplace; however, there are important and very different considerations for manufacturers of Class II and III products in this territory than in any other part of the … Continued
At present, China has approximately 77,000 medical device registration certificates and 3.7 million medical equipment records, making the process of obtaining, tracking and managing classification documentation a rather large feat. On September 4, 2017, in an effort to simplify the classification process, the China Food and Drug Administration (CFDA) introduced a new version of the … Continued
As any device manufacturer is aware, medical products throughout the globe are regulated according to each device’s targeted country of distribution. While conventional and/or equivalency products typically have a clearcut regulatory pathway, new or improved medical devices are often comprised of time-intensive and sometimes confusing regulatory approval routes. This is especially true for multinational manufacturers … Continued
July 17, 2017 – TOKYO, JAPAN – (BUSINESS WIRE) – NAMSA, the world’s only Medical Research Organization (MRO) that accelerates medical device development through integrated laboratory, clinical and consulting services is excited to announce the launch of its newly developed Japanese website. The introduction of this highly-anticipated website is a direct result of the increased … Continued
Like several other geographies throughout the globe, the Country of Japan has its own Quality Management System (QMS) Ordinance for medical devices, which subsists of ISO 13485 requirements and additional country-specific standards. All medical products marketed and sold in Japan must be manufactured in accordance with these QMS requirements in mind. It is important to … Continued
On May 19, 2017, China’s State Council issued the “Supervision and Regulation of Medical Devices (No. 680),” just three years following the State Council Decree No. 650, which addressed similar regulations, including how medical devices should be supervised. While there are many parallels between the two regulations, there are three significant areas of change that … Continued