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CDSCO urges medical device cos to register products by April 2020 in Sugam portal for timely approvals

Shardul Nautiyal, Mumbai
Thursday, February 14, 2019, 08:00 Hrs  [IST]

In order to create a comprehensive database of medical devices manufactured, tested, clinically investigated and validated through a quality management system (QMS), the Central Drugs Standard Control Organisation (CDSCO) has urged the medical devices companies to register their respective products by April 2020 in the Sugam portal for getting product approvals timely.

As of today, 37 medical device categories have been notified. Earlier 26 medical devices were notified between 2005 and 2017 which had under its ambit 364 products. In December, 2018 three new devices like nebuliser, glucometer and surgical gowns were notified.

In a notification dated February 8, the ministry has brought all implantables along with eight new medical equipments like CT scan equipment, MRI equipment, defibrillators, dialysis machine, PET equipment, X-Ray machines and bone marrow cell separator under the regulatory framework. The rule will come into force in April 2020. Once regulated, the CDSCO will be the approving authority for import, manufacture and sale of implantable medical devices.

The companies have also been told to share the details of products registered with them to conclude the baseline study. It would help the Indian drug regulators to verify about faulty medical devices available or banned in other countries also.

The Indian Pharmacopoeia Commission (IPC) has also launched four unique tools - medical device adverse event (MDAE) reporting form, medical device recall notification form, registered medical device information sharing portal and medical device reference document on February 8, 2019 to create an accountable regulatory ecosystem for medical device industry towards patient safety.

MDAE reporting form will help generate independent, evidence-based recommendations on the safety of medical devices and to communicate the findings to all key stakeholders.

A registered medical device information sharing portal would serve the purpose of India specific tool which would help IPC to facilitate the baseline study of products available with medical devices companies in India. It would help the Indian drug regulators to verify about faulty medical devices available or banned in other countries also.

Union health ministry is also planning to create a Registry of High Risk Medical Devices to track usage of high risk medical devices in India mandatorily. The same would be worked out taking reference of international scenario so that serious adverse events (SAE) can be prevented soon before it arises from the manufacturer’s end.

Medical device reference document will serve as a reference manual for stakeholders such as medical device manufacturers, license holders, regulators, healthcare professionals etc. This document has, inter alia, adopted regulatory requirements and quality management system as specified in the Drugs & Cosmetic Act (D&C Act), 1940 and Rules framed thereunder.

The standards adopted in this document are from the Medical Device (MD) Rules 2017, the Indian Pharmacopoeia (IP), 2018 and other Pharmacopoeia such as British Pharmacopoeia (BP), Japanese Pharmacopoeia (JP), European Pharmacopoeia (EP) etc and also the standards as prescribed by the Bureau of Indian Standards (BIS).


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