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Qosina Announces Scott Herskovitz as New President & CEO

Ronkonkoma, NY,USA,January 3, 2018—Qosina Corp. is pleased to announce the appointment of Scott Herskovitz to president and chief executive officer, effective immediately. As president and CEO, Scott will have responsibility for development and execution of the company’s strategic plan.

“I am very excited about the future of Qosina and look forward to continued positive growth under Scott’s leadership,” said Qosina Chairman of the Board Stuart Herskovitz. “Scott’s experience, strategic thinking and proven ability to deliver results make him the perfect person for this role. His vision and communication style will bring a new level of engagement and performance from the employees. I enthusiastically welcome Scott as Qosina’s new leader.”

Prior to his promotion topresident and CEO, Scott worked in business development, served as vice president of marketing, and later, vice president of sales and marketing at Qosina. “I am thrilled and honored to take on the role of president and CEO of Qosina,” said Scott Herskovitz. “Stuart Herskovitz had a vision 38 years ago of what he wanted the Qosina brand to be. He worked hard to build the company into the global powerhouse that it is today and a trusted partner to our customers, distributors and vendors. Stuart is a leader of great integrity, character and intellect. I look forward to building on the Qosina foundation and taking the company to the next level by helping our customers find, order and receive quality medical components quickly and accurately.”

Founded in 1980, Qosina is a leading global supplier of OEM single-use components to the medical and pharmaceutical industries. Qosina’s philosophy is to address its customers’ need to reduce time-to-market by providing thousands of stock components. The company’s vast catalog features more than 5,000 products shown in full-scale illustrations on a onecentimeter grid. Qosina offers free samples of most items, low minimum order requirements, just-in-time delivery, modification of existing molds, and new product design and development. Qosina isISO 9001, ISO 13485 and ISO 14001 registered, and operates in a 95,000 square-foot facility with an ISO Class 8 Clean Room. visit or call +1 (631) 242-3000.

Contact : Qosina Corporation, Rachelle Morrow
+1 (631) 242-3000,

DCGI Issues Classification Of Medical Devices & In Vitro Diagnostics

The Drugs Controller General of India (DCGI) has issued classification of medical devices and in vitro diagnostic medical devices under the provisions of the Medical  Devices Rules, 2017.

These Rules will be applicable to substances used for in vitro diagnosis and surgical dressings, surgical bandages, surgical staples, surgical sutures, ligatures, blood and blood component collection bag with or without anticoagulant covered under subclause (i); substances including mechanical contraceptives (condoms,  intrauterine devices, tubal rings), disinfectants and insecticides notified under sub-clause (ii); and devices notified from time to time under sub-clause (iv), of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940 (23 of 1940).

As per the Rules, medical devices other than in vitro diagnostic medical devices will be classified on the basis of parameters specified in part I of the first schedule, namely low risk as Class A; low to moderate risk as Class B; moderate to high risk as Class C; and high risk as Class D. In vitro diagnostic medical devices will be classified on the basis of parameters specified in part II of the First Schedule, namely low risk as Class A; low to moderate risk as Class B; moderate to high risk as Class C; and high risk as Class D.

Safety, quality and performance of medical devices are regulated under the provisions of the Drugs and Cosmetics Act, 1940 and rules made thereunder. In this connection, in exercise of the powers conferred under sub-rule (3) of rule 4 of Medical Devices Rules, 2017, the DCGI has classified the medical devices and in vitro diagnostic medical devices, based on the intended use of the device, risk associated with the device and other parameters specified in the First Schedule.

As per the classification issued by the DCGI, Radiofrequency Ablation Device, Percutaneous Conduction Tissue Ablation, Coronary stent, Bioresorbable Vascular Scaffold (BVS) System, Angiographic Guide Wire, Cardiac Catherization Kit, Balloon for Cerebrovascular Occlusion, Intra-Aortic System Balloon and Control, RETRIEVAL SNARE, Cardiac Thermodilution Catheter, Cardiovascular Catheter, Cerebrospinal Catheter, Atherectomy coronary Catheter, to name only a few, have been listed in the high risk Class D category.

Vein Ablation device, Thermal Ablation device, Uterine balloon therapy devices, RF Conducte MR steerable electrode catheter, Bone cement, Bifurcation Stent, Vena Cava Filter Sets, Central Venous Catheters, Introducer Sheath, Carotid Filter System, Hemodialysis Catheter (Long Term), Percuataneous Intravascular Long Term Catheter, Implanted Subcutaneous Intravascular Port & Catheter, Subcutaneous Intraspinal Port & Catheter, Coronary Dilation Catheter, Diagnostic Radiology Catheters, Micro-catheter, Tympanostomy Tube, Anastomosis Bypass Tube, etc have been listed in the moderate to high risk Class C category.

Fiberoptic Oximeter Catheter, A-V Shunt or Fistula Adapter, Forceps endoscopic, Vessel Dialator for percutaneous Catheterization, Tracheobronchial Suction Catheter,  Cervical Drain, Rectal Balloon, Vial Adapter, Nasopharyngeal Catheter/ Nasophar yngeal, Esophageal obturator, Suction Tip and Catheter, Arterial Catheter, Cholangiography Catheter, Umblical Artery Catheter, Flow Directed Catheter, Endoscopic Ligation Devices, Dialysate Tubing and Connector, Colon Tube, Connecting Tube, Decompression Tube, Biopsy Needle Kit, Mammary Biopsy Needle, Cholangiography Needle, Epidural Needle, etc have been included in the Class B category.

Nasopharyngeal Catheter/Nasophar yngeal, Y-Connector as an accessory to perfusion sets, Surgical Dressings, Umbilical occlusion device, Bolster Suture, Alcohol Swabs, etc have been included in the Class A category.

(Ref: NewsDetails.aspx?aid=105268&sid=1)

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