Before undergoing registration application in China, medical devices shall be sent to medical device inspection agencies for examination to ensure that the products meet national standards. CFDA has issued a notice on the examination work to ensure the efficiency of registration of medical devices. The details of the notice are as follows:
More Malaysian lawmakers take medical device related issues pretty seriously, starting with the introduction of the Medical Device Act 2012 (Act 737) and Medical Device Regulations 2012. A faulty pacemaker or even a leaking catheter are the last things patients need to worry about as they may pose various levels of threat to their lives.
More Starting from January 1, 2018, the Malaysian Communications and Multimedia Commission (MCMC) no longer permits any kind of Short Range Devices (SRD) and Radio Frequency Identification Devices (RFID) to operate in the frequency range from 869 MHz to 870 MHz.
More On November 16th of 2017, Philippine Food and Drug Administration (FDA) announced that the importation and exportation of radiation devices that can be ionizing and non-ionizing shall not be allowed to enter the country unless a Clearance for Customs Release (CFCR) has been issued by the Center for Device Regulation,
More On December 15, 2017 Philippine Food and Drug Administration (FDA) announced some changes in the Application of Variation of Certificate of Product Registration for Medical Devices.
More On December 4, 2017, Philippine Food and Drug Administration (PFDA) announced that Philippine Food and Drug Administration (PFDA) Cashier will be accepting cash payments for all applications from 8:00 AM to 5:00 PM, Monday to Friday, at the Food and Drug Action Center (FDAC), Civic Prime Building, Filinvest City, Alabang Muntinlupa City, until further notice.
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This means that the Marketing Authorization License for Class B, C, and D medical devices will be delayed for one year from the original date set forth under Decree 36. Thus, with the official release of the Dispatch 7165 in Vietnam, some specific interim regulations are as follows:
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According to the post-show figures from the organizer, PT. OSI, indicate that medical device should be set for a prosperous year ahead in 2018 of a record-breaking attendance of more than 43,869 and 518 exhibitors from 46 countries. Around 40% of exhibitors were international, with more than 54% from China, 22% from Taiwan and 12% from South Korea.
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On November 14th 2017, Center for Medical Device Evaluation (CMDE) released "The Draft of the Guidance of Accepting the Overseas Clinical Trial Data for Medical Device", which is applicable to medical devices (including in vitro diagnostic reagents, IVDs).
More The Clause 29th of "The Guidance of Registration for In-vitro Diagnostic Reagent” clarifies that for in-vitro diagnostic (IVD) reagents exempt from clinical trial, the applicant is responsible for the evaluation of the clinical performance of the IVD reagents by means of evaluating the clinical samples from the intended use, interference factors, comprehensive literatures and other pre-clinical data.
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