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Morepen Labs is actively seeking CE (Conformité Européene) Certification for its medical devices facility at Baddi in Himachal Pradesh, Sushil Suri, Chairman and Managing Director of the company said.
Receiving ISO certification from British Standards Institution in UK has paved way for Morepen Labs to now seek CE certification, both of which are open export markets for the company in European countries.
“This ISO-13485 certification opens new vistas for Morepen to export its diagnostic devices to various countries across the globe and also to seek CE Certification for the European Union. Having complied with all the important technical and regulatory guidelines for the Quality Management Systems as per ISO-13485, the company is confident of securing CE certification for its products as a next step,” said Suri.
The ISO-13485 standard is an international standard which specifies requirements for Quality Management Systems (QMS) that are to be used by an organisation involved in one or more stages of the life-cycle of a medical device. This certification is recognized by most regulators across the globe including those in the United Kingdom and the European Union. Compliance with this standard ensures the consistent production, delivery and after sales service of medical devices that are safe for their intended purpose.
Morepen has received ISO certification for the manufacturing, distribution and after sales service of all point-of-care diagnostic medical devices and their accessories manufactured at its Baddi facility after multiple audits.
Morepen’s Baddi facility manufactures medical devices including Blood Glucose meters, Blood Glucose Testing Strips, Blood Pressure Monitors, Thermometers, Pulse Oximeters and Stethoscopes. It is one of the largest manufacturers for point-of-care diagnostic devices in India by unit volumes, especially for Blood Glucose Monitors with over 3.30 million active usersin the SAARC region and has sold over 425 million blood glucose testing strips.
Morepen has launched Covid-19 products such as non-contact infrared thermometers, alcohol-based hand sanitizers, hand wash and rubs and 2-ply as well as 3-ply face masks.
The company has also received license to manufacture Hydroxychloroquine (HCQ) from State Drug Controller (HP) for its Baddi plant and is working towards commercializing its production in both API as well as tablets form.
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