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CliniExperts Announces Expert Services for Medical Device Registration in India

Monday, November 21, 2016 Medical Gadgets J E 4
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NEW DELHI, November 21, 2016 /PRNewswire/ --

According to the Central Drugs Standard Control Organization (CDSCO), regulation of medical devices is primarily focused on quality control and the assurance of efficacy and safety of a medical device. CliniExperts Service Private Limited , a leading regulatory services provider in the Indian market, has now launched a customized project management software owing to its decade-long experience in the field, to provide faster services for manufacturers and importers of medical devices and help ease regulatory procedures, based on the guidelines of CDSCO. Making processes easier, they provide end-to-end solutions to your medical device regulatory requirements including the import and registration of medical devices.

CEO speak  

Dr. Ashwini Kumar, MD (AIIMS), CEO of CliniExperts, expressed his delight at introducing this new service. Dr. Kumar said that, "The CDSCO is expected to launch a new set of guidelines soon as the demand for the update on the guidelines of registration of medical devices in India has been felt for a while now in the industry. The new guidelines are expected to make the process of import and registration smoother and hassle-free. CliniExperts professionals will be abreast with these new registration procedures and will extend all help to manufacturers and importers. Our years of expertise as a regulatory solutions provider have won us the trust of numerous clients as a trusted player in the market."

Classification of medical devices:

As per the Ministry of Health and Family Welfare, Govt. of India, under the Drugs and Cosmetics Act, 22 medical devices have been classified into Notified and Non-notified categories. The list of 14 Notified Medical devices are as follows:

  • Disposable Hypodermic Syringes
  • Disposable Hypodermic Needles
  • Disposable Perfusion Sets
  • In-vitro Diagnostic Devices for HIV, HbsAg, and HCV
  • Cardiac Stents
  • Drug Eluting Stents
  • Catheters
  • Intra Ocular Lenses
  • I.V. Cannulae
  • Bone Cements
  • Heart Valves
  • Scalp Vein Set
  • Orthopedic Implants
  • Internal Prosthetic Replacements

The following is a list of the 8 non-notified medical devices:  

  • Blood Grouping Sera
  • Ligatures, Sutures, and Staplers
  • Intrauterine Devices (Cu-T)
  • Condoms
  • Tubal Rings
  • Surgical Dressings
  • Umbilical Tapes
  • Blood/Blood Component Bags

Note that the above lists are as per the old guidelines, and new guidelines are soon expected. The licenses for registering any of these devices can be obtained through the SUGAM online portal that was launched by the CDSCO in January 2016. It can be used for the filing of applications for registration certificate as well as import license application for notified medical devices. This portal has streamlined the application process and CliniExperts has already helped clients to procure their import licences and registration certificate (for medical device registration in India ) through this online medium. Noteworthy, CliniExperts has always been at the cutting edge of technology in the regulatory market and uses a state-of-the-art Project Tracking Software System which helps in timely execution of projects.

About CliniExperts:  

CliniExperts is a one-stop solution for all regulatory needs. Armed with years of expertise in the regulatory services field, we can assure you the smooth processing of the import licence and registration certificate of your product.

Media Contact: Ms. Rashmi Verma rashmi.verma@cliniexperts.com +91-11-40536928 COO, CliniExperts Service Private Limited

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