Brazil Reports Half of GMP Certificates Now Issued Under MDSAP
Brazil’s ANVISA has reported that almost half of the GMP certificates it issued in 2019 were under the Medical Device Single Audit Program.
In 2019, the MDSAP program met its milestone of 5,000 participating companies, and 48.7 percent of the total international health product certificates issued by ANVISA were made using the MDSAP program.
In 2019 ANVISA issued 321 GMP certificates under MDSAP compared to 107 certificates in 2018 and just 38 in 2017. It conducted 84 international health product inspections in 2019 compared to 110 in 2018 and 238 in 2017.
With the increase in companies participating in the program, ANVISA can “conduct fewer inspections and focus resources on the most risky situations, ensuring efficient use of public money,” the agency said.
In addition to resource savings, MDSAP represents an increase in health safety since auditors inspect companies more frequently, reporting to the agency annually as well as to other agencies participating in the program.
ANVISA is a founding member of MDSAP, having developed the program along with the FDA, Japan’s Pharmaceuticals and Medical Devices Agency, Australia’s Therapeutic Goods Administration and Health Canada.
UK Issues Class II Recall for Pre-Filled Emerade Adrenaline Pens
The UK’s Medicines and Healthcare products Regulatory Agency issued an alert that Emerade adrenaline autoinjectors have failed to operate, and PharmaSwiss (a Bausch & Lomb affiliate) is recalling all unexpired batches.
Bausch & Lomb has determined that one component of the autoinjector has failed to activate, particularly when pens are exposed to high temperatures.
The MHRA advised healthcare professionals to stop supplying the products and to quarantine all remaining stock and return it to the supplier. The agency noted that in the UK there is an insufficient supply of alternative brand adrenaline pens to replace all the Emerade pens held by patients.
The agency said that EpiPen and Jext strengths of 300 mcg could be used instead of 500 mcg Emerade pens. The MHRA advised that patients traveling to hot climates should carry an alternative brand pen.
Malaysia Opens Consultation on Orphaned Devices
Malaysia’s Medical Device Authority is asking for industry input on a proposal to allow the continued use of orphaned devices that can’t be registered because the manufacturer or authorized representative in Malaysia is no longer available.
There are numerous such devices that were in use in hospitals before Malaysia enacted a new medical device law in 2018. The act made it illegal to sell devices without a license, which means that many devices would need to be withdrawn from the supply chain.
The agency is proposing that the devices continue to be used, and that healthcare facilities with orphaned devices identify and provide notification.
The healthcare facilities will be responsible for the device rather than the manufacturer or authorized representative. The notifier can be a local government, private healthcare facility or a related facility.
Read the guidance here: www.fdanews.com/12-06-19-MDGuidance.pdf.