Significant milestone opens market access for VibraCool® and Buzzy® pain relief platforms to America’s biggest trading partner
ATLANTA, GEORGIA, USA, October 26, 2021 /EINPresswire.com/ — MMJ Labs, LLC, d/b/a Pain Care Labs, a commercial-stage medical device company with a first-in-class pain canceling platform, today announced it has been approved by Health Canada for a Medical Device Licence ("MDL"). The MDL expands beyond the control of pain associated with needle procedures to include control of fear associated with injections, venipuncture, IV starts, lab draws, blood donation, cosmetic, and dental injections.
The Company will begin exporting immediately to serve customers who have been waiting for this news for a decade. Inquiries from healthcare providers in British Columbia to Nova Scotia resemble this one from Alberta: “I'm just wondering if Buzzy has been approved yet in Canada? We're still advocating strongly to have Buzzy available as we roll out our Commitment to Comfort project.”
By receiving this MDL, Pain Care Labs demonstrates it is fully compliant with Health Canada's Medical Device Regulations, including satisfying medical device, biological, and electrical standards throughout the design and manufacturing of the devices. MDL ensures the safety, effectiveness and quality of medical devices in Canada by a combination of pre-market review, post-approval surveillance, and quality systems in the manufacturing process.
Pain Care Labs satisfied the strict regulatory standards set by Health Canada to obtain a Medical Device Licence. After rigorous review, Health Canada issued the MDL, authorizing Pain Care Labs to sell its Class II medical devices. Under the MDL, VibraCool devices are cleared to treat myofascial pain caused by trigger points, restricted motion, and muscle tension, and to increase muscle strength and flexibility with physical therapy.
"Approval from Health Canada provides alternative pathways for patients and health care providers in the treatment of a variety of medical conditions,” observed Valerie Staffey, Director of Regulatory Affairs at Pain Care Labs. "Quality control is crucial for any medical device, and we are pleased that Health Canada has certified that our devices meet Canada’s high standards."
The MDL from Health Canada was possible because of an earlier achievement in July 2021, ISO 13485:2016 Certification for Medical Device Manufacturing Quality. "As we've transitioned from a tech start-up to neuromodulation platform medtech company, recognition for the quality systems we have in place is important. Building upon ISO 13485:2016 certification earlier this year, MDL allows entry to a market where demand has been high for over a decade,” observes CEO Amy Baxter MD.
“Quality and science-based efficacy have been our core values since our founding," notes Jennifer Tipping, Director of Global Business Development at Pain Care Labs. "Approval from Health Canada is further evidence of our commitment to safety, product performance, and effectiveness." Pain Care Labs will begin shipping its healthcare product line to Canadian professionals immediately.
ABOUT PAIN CARE LABS
Pain Care Labs (a d/b/a of MMJ Labs, LLC) is the industry leader in non-invasive pain relief solutions. Since 2010, the Company has exported drug-free pain relief around the globe. The Company’s VibraCool® line reduces pain after surgery or injury and treats pain from muscle restriction. The Company’s Buzzy® products are used to improve adherence to biologics, vaccines, and lab work. Established in 2006 by emergency physician and pain researcher Amy Baxter MD, the Company is dedicated to effective, reusable, and affordable solutions for pain. The Company’s award-winning solutions are based on patented M-Stim™ and Oscillice®, a mechanical stimulation/thermal neuromodulation platform. Pain Care Labs was named "Industry Leader for Localized Pain Relief" by Frost & Sullivan, a leading market research firm. For more information, including a list of published studies, please visit PainCareLabs.com.
Addressing Needle Fear with Pain Care Labs
Source: EIN Presswire