Registration holder for Medical Devices Imported from Mexico.
GRP Mexico can help you obtain COFEPRIS medical device registration and approval to sell your product on the Mexican market.
Brazil’s ANVISA has completed the process of joining the Pharmaceutical Inspection Co-operation Scheme (PIC/S). The Agency will become the 54th member of the international pharmaceutical inspection initiative.
Anvisa published the Resolution (RDC 348/2020) to speed up the evaluation of new products for detection of the new coronavirus (SARSCoV-2). Check out GRP’s blog on all the required documents necessary to register COVID-19 rapid tests with Brazil’s Anvisa.
Singapore’s HSA implements Provisional Authorization Process to Expedite Approval of COVID-19 Diagnostic Tests
Singapore HSA implements provisional authorization process for kits intended to detect and/or diagnosis COVID-19 infection to address the need for COVID-19 diagnostic tests.
As of 1 July 2020, medicine advertisements in specified media will no longer need pre-approval from Australia’s (TGA)
In Australia, the Therapeutic Goods Administration (TGA) regulates all vitamins for safety and quality. The TGS has set specific requirements such as permitted ingredients, indications and GIMP for vitamins .
On April 23, 2020, China’s NMPA issued the revised Standard for Quality Control of Drug Clinical Trials (No. 57 of 2020) and will be implemented on July 1.
On April 14, 2020, China NMPA published a new notice to Enhance Quality Inspection for Sterile and Implantable Medical Devices new notice on its new plan to perform random inspections to medical device manufacturers in China
Brazil’s Anvisa Releases New Technical Note on the conduct of clinical trials during the COVID-19 pandemic.
Brazil’s Anvisa issues technical note that gathers the latest guidelines on the conduct of clinical trials in the face of the new coronavirus pandemic.
The European Union’s new In Vitro Diagnostic Regulations (EU IVDR 2017/746) action is delayed due to COVID-19.
On 2017, China began the harmonization of their pharmacovigilance structure when they joined the ICH. GRP’s blog breaks down the structure of china reporting system and the requirements of a PMF.