About Medical Devices Bill In Parliament

Momentum is building to introduce the new medical device bill in the Parliament. Reports indicate that the Health Ministry has sent a note proposing the new bill to the Cabinet Secretary for approval of the Union Cabinet.

The bill that would replace the earlier Drugs and Cosmetic Act is expected to lay down separate provisions for Medical Devices including a separate definition of them, their riskbased classification for regulatory control, Clinical Trials on Medical Devices, Conformity Assessment Procedures, Penal provisions, etc...

Medical Device Bill: Expert Opinions & Insight

Elucidating the role of CDSCO and the future ahead, Rajiv Nath, Forum Coordinator, Association of Indian Medical Device Industry (AIMED) says, “After the bill on Regulation of Medical Devices and Patient Safety is passed by a National Regulatory Authority under the Ministry of Health, the current CDSCO’s role could be enlarged with more autonomy and renamed as the Indian Healthcare Regulatory Authority with decentralized Divisions for Drugs, Cosmetics, Medical Devices and Diagnostics.”...

Medical Device Industry Wants Govt. To Ensure Quality Of Components & Raw Materials

With a view to ensure steady growth of medical device sector in the country, the industry wants the government to take immediate measures to formulate rules that will help in regulating and monitoring the components and raw materials required for it..

The industry experts stressed that absence of a designated regulatory machinery in this segment is leading to a lot of quality issues for the medical devices affecting their growth and reputation. This they pointed out is because the quality of the end product to a large extent depend on the quality of the raw materials and components used by the end manufacturers...

Medical Device Packaging

World demand for medical device packaging is projected to increase 5.9% annually to £16.6bn ($25.7bn) in 2017. Western Europe, the US and Japan will continue to account for almost 60% of the total market, according a new report by Freedonia. Demand in these countries will expand below the average global pace as intensifying health care cost containment pressures and fierce multiple supplier competition weaken growth...

ASEAN Medical Device Harmonization Update

While many details of the AMDD are left to member countries, the important details of classification and data requirements are the same for every country in the ASEAN region. Although this will place an additional burden on foreign device manufacturers selling to countries like Cambodia (which formerly had no system for registering medical devices), it will also, hopefully, establish a common registration system and reduce uncertainty in the market. Further, the AMDD may open the door to other forms of regulatory integration within ASEAN, such as integrated abridged registration processes and common product approval procedures...