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Additional Steps Announced by FDA to Modernize Clinical Trials

The U.S. Food and Drug Administration has made draft guidance available with updated recommendations for good clinical practices (GCPs), which are intended to modernize the clinical trial design and conduct while maintaining data integrity and […]

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Accreditation and Registration Numbers for Foreign Manufacturers Publication by PMDA 

This article deals In accordance with the Pharmaceuticals and Medical Devices Act (PMD Act) of Japan, foreign businesses that wish to produce pharmaceuticals, quackery products, active pharmaceutical ingredients (APIs), or medical devices abroad and import […]

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BSI New Certification to Mitigate Antimicrobial Resistance Risk in Antibiotic Manufacturing

BSI, the business improvement and standards company, has developed a new certification to mitigate the risk of antimicrobial resistance (AMR) in antibiotic manufacturing. The certification, called the Minimized Risk of Antimicrobial Resistance (AMR) certification, will […]

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TUV SUD Inspects IVD Medical Devices’ Cyber Security

The growing digital connectivity of medical infrastructure is resulting in complicated systems with a plethora of diverse interfaces that are potentially vulnerable to assault. The IVD requires producers to provide proof of cyber security before […]

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TGA Supports MHRA’s New Regulations

The TGA made a commitment to support the MHRA‘s new Regulations worldwide recognition framework for pharmaceuticals. Following the UK’s exit from the European Union, a new international recognition framework for medicines has been developed specifically […]

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Medical Devices with Extended CE Certification Are Now Accepted On The UK Market

The MHRA revised its guidelines to make clear its stance and reflect its intention to extend the acceptance of CE-marked medical devices on the British market beyond June 30th, 2023. A statutory document that will […]

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The NMPA Enhanced Regulation of Cosmetic Medicine

According to a representative of the State Administration for Market Regulation, after the industry’s quick development, prominent issues like unethical medical practices, fake goods, false advertising, and price fraud emerged, endangering the health and interests […]

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Radiation Sterilization Master File Pilot Program Announced by CDRH

CDRH is establishing a Radiation Sterilization Master File Pilot Program to assist businesses in developing less troublesome regulatory methods for sterilizing licensed medical equipment, such as switching radiation sources. The pilot program, which is optional, […]

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