The regulatory standards for the approval of IVD devices keep on changing time to time because of the continuous improvements and modifications made related to their better performance level. There was a revision for “glucometer test strips” in 2013 as mentioned in IS/ISO 15197: 2013.
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MDA has released a new regulatory update, pertaining to Licensing Conditions for All Licensed Establishments under the Medical Device Authority in Malaysia. There have been some critical inclusions to the licensing requirements for all licensed establishments in MDA.
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Outcomes of these consultation sessions have been consolidated and new revisions to the existing guidance documents and issuance of new guidance documents are to be carried out in stages, after this.
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The annual and well-known event is taken place twice a year in Ho Chi Minh City in August and Hanoi City in December, respectively. Vietnam Medi Pharm Expo has been organized for fifteen years in promoting trade activities of the pharmacy and medical equipment, strengthening local and foreign business to business operations.
More Vietnam Ministry of Health released the draft decree mention some points of Medical Device Management under Decree 36/2016/ND-CP. After the detailed analysis, Qualtech has outlined five major differences between the new and previous version of regulations:
More This month’s updates include the "Internet+Medical Health", “the Special Approval Procedure for Innovative Medical Devices”, “the Revision Plan of Medical Device Standards” among others. All information you need to know has been put in a nutshell:
More Administrative Order 2018-117, otherwise known as the “Effectivity of the New Schedule of Fees” was released in the 2nd of April, 2018 to inform all the FDA Stakeholders and the General Public that a new schedule of fees shall be implemented on the 30th of June 2018.
More Health Sciences Authority (HSA) published the list of new fees applicable to health products including Medical devices, on last August 1, 2018.
More Large medical equipment is a special type of medical equipment with complex technology, large capital investment and high operation cost, having a great impact on medical expenses. In order to optimize the allocation of large medical equipment in the hospitals,
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