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Tag: ANVISA

First-Ever Legal Exports of THC From Jamaica to the United States

MONTEGO BAY, Jamaica — Pure Jamaican and its GMP-certified, licensed pharma manufacturer Seven-10 Pharmaceuticals are elevating Jamaica’s role in the global cannabis supply chain by legally...

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ANIVSA on importation (accessories, combination products and refurbished devices) – RegDesk

The new article addresses aspects related to the regulatory requirements for the importation of medical device accessories, as...

Ibogaine For Addiction: 5 Reasons Why It’s Safer To Do It In A Hospital

By Santiago Federico Richetti via El Planteo / Reviewed by Dr. Bruno Rasmussen Chaves Ibogaine is a substance extracted from the root of the iboga, a shrub that grows...

Allurion signs SPAC deal to go public

<!----> Weight loss device company Allurion has entered a business combination with special purpose acquisition company (SPAC) Compute...

ANVISA Guidance on SaMD: Various Use Examples

The new article addresses the aspects related to the regulatory requirements to be applied with respect to the...

ANVISA Guidance on SaMD: Data Processing Solutions

The new article describes in detail the aspects related to the products intended to process medical records, as...

ANVISA Guidance on SaMD: ECG Products and Systems

The new article highlights the points related to the regulatory approach to be applied in the case of...

ANVISA Guidance on SaMD: Various Supply Types

The new article provides additional clarifications regarding the regulatory status of software products with different types of supply,...

ANVISA Guidance on SaMD: Remote Diagnosing and Administrative Software

The new article describes in detail the aspects related to various software products, including the ones intended for...

ANVISA Guidance on SaMD: Telemedicine

The article addresses the aspects related to the products used for the provision of telemedicine services.  ...

Brazil Permits Onboard Service to Return on Domestic Flights

The Brazilian Health Regulatory Agency (Anvisa, in Portuguese) has eased the sanitary requirements for airports and aircraft, allowing onboard service to resume. Brazil is proposing...

Versius adopted for urological procedures in Pakistan

CMR Surgical – the global surgical robotics business – has announced the successful completion of high-volume urological procedures at the Sindh Institute of Urology and Transplantation using the next generation surgical robotic system, Versius®, in Pakistan.

Therma Bright Awaits FDA-EUA Approval From Over 260 AcuVid(TM) Clinical Study Test Results

Toronto, Ontario--(Newsfile Corp. - July 22, 2021) - Therma Bright Inc. (TSXV: THRM) ("Therma" or the "Company"), developer of its smart-enabled AcuVid™ COVID-19...

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