Category — Medical Technology

Regulators Publish New Rules for Medical Devices in India

After exhaustive stakeholder consultations, the Government of India published the new medical device and in vitro diagnostic regulations (IVD) on Jan 31, 2017. The Medical Device Rules, 2017, issued by the Ministry’s Central Drugs Standard Control Organization, will replace India’s longstanding Drugs and Cosmetics Act upon implementation. The new rules will go into effect January 1, 2018.

The term “medical device” includes any instrument, apparatus, appliance, implant, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specially for human beings or animals for one or more of the specific purposes, reports the Economic Times.
Central Drugs Standard Control Organization Logo
Highlights:
  • The new rules endorse a risk-based classification plan for medical devices and IVDs.
  •  Unique identification of medical devices and IVDs will be required by regulators, starting January 1, 2022.
  • Licenses issued to device registrants will remain valid indefinitely, along with payments of license retention fees, unless cancelled or surrendered.
  • The rules include fee revisions based on device classification.
  • Test licenses will remain valid for three years (currently, these are valid for one-year periods).
  • It is mandatory to have Notified Bodies (legal entities) conduct audits of device-manufacturing sites in India before manufacturing licenses can be issued.
  • Licenses and registration certificates obtained prior to implementation of the new rules will remain valid either until expiry or after an 18-month period following implementation, whichever is later.

The Medical Device Rules 2017 in its entirety is available on request. Please use this link to get a copy.

 

 

February 11, 2017   No Comments

India’s Institute of Technology Develops Cardio Implant

The Indian Institute of Technology Madras located in Chennai, India has developed Asia’s first ‘life-saving’ implant called SynkroScaff — A tissue engineered bovine pericardial patch — for critical cardiovascular patients. A Chennai-based firm, SynkroMax Biotech, has been appointed as the commercial partner. C.V. Seshadri, managing director of Synkromax Biotech said, “This sack is harvested and processed with biomaterial for ten days followed by quality control parameters to ensure it is microbial free.”

Tissue Engineering

The  pericardial patch (sack of buffalo’s heart) has inherent properties of regeneration and integration in the body, and its medical application is based on innovator Guhathakurta’s doctoral research in the institute in 2004, under the guidance of Venkatesh Balasubramanian, professor, Department of Engineering Design. Guhathakurta says, “Its applications are immense in cardiovascular and other surgical practices.  So far, 800 patches have been manufactured and over 12 surgeons are using them across India.  The feedback from doctors and patients has been encouraging, with a 100 percent success rate,” she said, adding that the product is manufactured in a facility complying with drug applications and current good manufacturing practice (cGMP) guidelines, reports the New Indian Express.

 

December 29, 2016   No Comments

Drexel Alumnus Develops Breast Cancer Scanner for India

Philadelphia’s Drexel University alumnus Mihir Shah, and Matthew Campisi have created the iBreastExam scanner which is a hand-held device that enables health workers to perform breast health examinations in virtually any setting, not just hospitals. “Mammography isn’t feasible in India due to high equipment cost and the lack of radiologists,” says Shah.

iBreastExam Machine

iBreastExam Machine

iBreastExam uses patented ceramic sensors developed at Drexel University to detect subtle variations in breast tissue, and offers the following features:

  • Bilateral breast exam within 5 minutes (with results at the point-of-care)
  • Accuracy to detect clinically relevant breast lesions is higher than 85%
  • Usable by any health-worker or doctor. No pain, No radiation

Forbes reports that the company UE Lifesciences Inc., with offices in both Mumbai and Philadelphia, will sell the product on a pay-per-use model instead of direct sales, which will enable doctors to immediately start offering private, safe and pain-free breast exams. Shah says he has kept the costs flexible; doctors at high-end private hospitals are charged in the range of  $10-$15 per test, whereas village clinics will be charged only $1.

 

December 15, 2016   No Comments

Ducere Pioneers Smart Shoes for the Blind

Headquartered in India’s southern city of Hyderabad, Ducere TechnologiesLe-chal (Colloquial Hindi: take me along), the world’s first interactive haptic footwear, gives vision to millions of visually challenged across the world to navigate through the sense of touch.

Founded in 2011 by electrical engineers Anirudh Sharma, a graduate of the Massachusetts Institute of Technology, and Krispian Lawrence, a graduate from the University of Michigan, the business has grown to a team of 110 engineers, designers, assembly operators, and sales staff.

Ducere Soles

The product can be synced to a user’s smartphone through bluetooth via the Lechal app that uses Google Maps to provide navigational directions towards the destination through vibrations and sensations. Subsequently, the company decided to expand the user base by innovating further and marketing it as a product anyone could easily use.

Ducere teamed with Hi-Tec Shoes, Europe, for co-branding and supplying insoles for Hi-Tec navigator shoes meant for hiking. It has distributors in India and North America. Its products are also available on Amazon, reports Outlook Business.

 

December 7, 2016   No Comments

India’s Perfint Develops Tools to Assist in Tumor Ablation

Chennai, India-based Perfint Healthcare, has developed MAXIO, an image-guided, physician controlled robotic system that assists physicians to visualize and plan an entire procedure such as tumor ablation in 3D. Once the plan is confirmed, MAXIO’s stereotactic arm, combined with intra-operative registration, assists surgeons  to advance one or more instruments accurately to reach the target.

Founders S. Nandakumar, K. Guruswamy, K. Puhazhendi and Gopalakrishna Kulkarni spent a decade at  GE Healthcare prior to creating this company. After talking to a number of radiologists and physicians in India, the team designed a product that  is useful in treating tumors and managing pain rather than just diagnosing the tumor.

MAXIO

Maxio, an FDA 510k approved device is used  in the  U.S., Germany, Australia and India. . “It’s the best money can buy in two important areas of medical technology. There are similar systems that only the first world can afford, but this one is world-class, cost-effective and for me, this is true advancement in medicine,” says, Dr Yuman Fong, chair of surgery at City of Hope, the cancer research hospital in Duarte, California,  reports Outlook Business.

December 2, 2016   No Comments