Meril Life Sciences Wins Singapore Approval for Dilatation Catheter

Share Article

India-based medical device company obtains Singapore market authorization with assistance from Emergo Group

Meril Life Sciences Pvt. Ltd., a medical device manufacturer specializing in products for coronary applications, has received regulatory approval to market its Mozec rapid-exchange PCTA balloon dilatation catheter in Singapore.

Available in multiple diameters and lengths, Mozec can be used in a variety of balloon angioplasty procedures.

Meril Life Sciences pursued medical device registration in Singapore for Mozec following moves in recent months by the country’s market regulator, the Health Sciences Authority (HSA), to develop a more transparent and efficient approval process. Emergo Group, an Austin, Texas-based medical device regulatory consulting firm with local offices in Singapore, assisted Meril to obtain marketing authorization from the HSA.

Meril Life Sciences regulatory team explains that Emergo Group’s expertise in multiple medical device markets including those in Southeast Asia was a major factor in deciding to partner with the consultancy. The manufacturer also had previous experience utilizing Emergo Group’s services in other medical device markets.

“Emergo Group is a globally present, professional regulatory consultancy, and Meril has had good success working with the firm due to their responsiveness and clear understanding of global regulatory requirements.”

“By registering Mozec with the HSA, Meril Life Sciences can now establish itself in Singapore’s dynamic and highly transparent medical device market,” says Bryan Gilburg, Vice President of Business Development at Emergo Group. “Our local presence in Singapore allowed us to provide hands-on support for Meril Life Sciences’ commercialization effort.”

Additional information:

Meril Life Sciences Pvt. Ltd.
Bilakhia House,
Opposite G M Bilakhia Stadium,
Muktanand Marg, Chala,
Vapi - 396 191, Gujarat, India
+91 260 3052 100

Emergo Group
611 West 5th Street, 3rd Floor
Austin, TX 78701
About Meril Life Sciences
Meril’s core objective is to design, manufacture and distribute clinically relevant, state-of-the-art and best-in-class medical devices to alleviate human suffering and improve quality of life. The company has a strong commitment towards R & D and adherence to best quality standards in Manufacturing, Scientific Communication and Distribution. Meril has successfully commercialized its CE marked low injury DES - BioMimeTM Sirolimus Eluting Coronary Stent System in more than 50 countries.

About Emergo Group
Emergo Group is an ISO registered medical device consulting firm with offices throughout North and South America, Europe, the Middle East and Asia. The firm has specific expertise in regulatory affairs, quality system compliance, clinical trial consulting, in-country representation and medical device distributor search consulting.

Share article on social media or email:

View article via:

Pdf Print

Contact Author

Stewart Eisenhart
Emergo Group, Inc.
(202) 627-2080
Email >
Follow us on
Visit website