Medical Device Regulations in Germany
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Medical Device Registration in Greece
Entering Greece market offers tremendous opportunities by medical device companies, but it is not without challenges.
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New notification by DCGI
Whereas a draft of certain rules further to amend the Medical Devices Rules, 2017 was published as required under sub-section (1) of section 12 and sub-section (1) of section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940) vide notification of the Government of India in the Ministry of Health and Family Welfare (Department of Health and Family Welfare)
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Medical Device Validation Master Plan (VMP)
A validation master plan (VMP) diagrams the standards associated with the capability of an office, characterizing the areas and systems to be approved, and gives a composed program for achieving and keeping up a certified facility.
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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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