Are You Preparing for the Medical Device Single Audit Program (MDSAP) Audit Process?
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Are You Preparing for the Medical Device Single Audit Program (MDSAP) Audit Process? Read More »
Why IVD Regulation Framework Is Done Separately?
Here is the blog for every IVD manufacturers to know about the IVD regulatory framework to improve the health and safety of patients and users.The utilization of the term \’in vitro\’, which in Latin signifies \’in glass\’, is an impression of the way that most by far of these tests were initially performed in a test tube.
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Ethiopia Medical device registration | Ethiopian Regulation
The ultimate guide for Ethiopia medical device registration by FMHCACA (Food, Medicine, and Health Care Administration and Control Authority). Learn more about the medical device and IVD\’s classification and approval process for Ethiopia.
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State FDA’s Commanded by DCGI on Sugam Portals Update
The Drugs Controller General of India (DCGI) has instructed state drug regulators to take necessary action and direct all the manufacturers on how to upload their manufacturing sites and formulation data on Sugam portal which will strengthen the drug regulatory system by way of improving the transparency, accountability as well as accessibility of the drugs in the country.
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Roles and Responsibilities: QMS and IVDR
One of the new key regions of obligations that should be characterized is the individual or people in charge of regulatory compliance per Article 15. In the event that more than one individual keeps up this job (to enable the maker to meet the openness necessity), the divisions of obligation should be recorded as a hard copy, for example, in sets of expectations, goals,
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Launch Procedure for Medical devices regulation
This regulatory topic has turned out to be progressively relevant, in front of the commencement to the EU\’s new medical device and in-vitro diagnostic rules, set to produce results on May 26, 2020 and 2022, respectively.
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Medical Device Registration In South Africa
For Medical Device Registration In South Africa, the South African government has established a new agency to manage the new medical device and pharmaceutical regulatory systems being produced in the country.
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