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 Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory
news in Asia. India is pushing ahead with previously
discussed plans to categorize certain classes of medical device as drugs.
The change will mean implants and imaging equipment are subject to more
burdensome regulatory requirements than in the past.
The Drugs Technical Advisory Board (DTAB) floated the idea of reclassifying "high end equipment" last year, leading the Drug Controller General of India (DCGI) Dr.
Eswara Reddy to seek the industry’s feedback on the idea.
The list of devices affected by the reclassification is unchanged from that
released by DCGI in June, and only slightly
different from the original DTAB proposal. The reclassification is a major change for the affected devices.
India lacks mechanisms to
regulate the quality and efficacy of most medical devices.
Of the thousands of types of devices sold in the country, just the
23 already treated as drugs are under the oversight of the Central Drugs
Standard Control Organization (CDSCO). Following
the reclassification, CDSCO will oversee approvals to
import, make and sell the eight additional device categories.
Pressure to increase oversight of medical devices in India has intensified as
the controversy over the effects of Johnson & Johnson’s hip
implants has raised awareness about how the system works
today. Once the reclassification takes place, devices similar to the J&J hip implants at
the center of the safety concerns will be subject to more stringent regulations in India.
TGA has clarified its guidance on the quarantine mechanism
it introduced during its latest revision of the recall procedure in Australia.
The update significantly expands TGA’s advice on the use
of the mechanism to suspend the supply of a product pending further investigation. When TGA released its guidance on the Uniform Recall Procedure for Therapeutic Goods (URPTG) late in 2017,
it provided scant advice on the quarantine mechanism, despite
it being a new addition to the range of non-recall actions
available to manufacturers. The guidance featured a few sentences
that did little more than define the mechanism. Version 2.1 of the
URPTG goes into far more detail. The updated guidance states that manufacturers should consider quarantining goods when they identify
a defect that may affect the safety, efficacy or performance of a drug or device.
When a company decides to take this action, it must send the
final signed quarantine notice for TGA to review. TGA
will send the notice to state recall coordinators, professional bodies and other organizations.
The manufacturer is responsible for distributing the
notice to either the wholesale, hospital or retail level, depending on the depth of the supply of the goods.
Once the investigation into the defect that triggered the supply
suspension is complete, TGA will review the findings before deciding whether to lift the quarantine or initiate a further recall action. The
quarantine section is one of two parts of the URPTG to undergo a significant
overhaul in the latest update.
The other major change covers consumer-level recalls.
That requirement is absent from the latest version of the guidance.
To support the new, more manufacturer-led approach, TGA is advising companies to create strategies for
reaching consumers. The goal is for manufacturers to know who their customers are and how these people access
their products. Armed with this information, TGA thinks manufacturers can target their recall notices at
their customers, potentially eliminating the need for blanket, mass-market advertisements.
TGA has released a clutch of guidance documents
intended to help manufacturers interpret the PIC/S Guide to
GMP. The documents cover the production of sterile radiopharmaceuticals labeled with fluorine-18, release
for supply (RFS) and releasing medicines manufactured at
multiple sites.
The Pharmaceutical Inspection Co-operation Scheme (PIC/S) guide to good manufacturing practices (GMPs)
is an instrument for harmonization of production practices around the world.
However, aspects of the guide can be interpreted in different ways,
creating a need for national regulators to help companies understand their takes
on the document. TGA released three technical guidance documents this week to provide such clarification. In each case, TGA has updated an existing technical document in light of revision 13 of the
PIC/S guide. TGA adopted the guide at the start of 2018 but told its inspectors to take a
"pragmatic" approach to the enforcement of new requirements throughout last year.
That’s the promise of the setup, anyway. Just after the new
lanes opened, some of the first guinea pigs seemed a little uncertain about their workings.
Watching others go through, Dereck Loero of Fort Collins, who said he’d used a similar screening lane in Amsterdam, pointed
out a shortcoming or two. He said adding benches right behind the pickup
area would give people space away from the belt where they can put their shoes back on. That caused some to linger, and empty bins backed up,
requiring agents to intervene despite officials’ assurance that the last step would go more smoothly.
"The technology is great, but at the end of the day … if they had a better flow, it would be easier on the workers," said Loero,
30, who was flying to Los Angeles.
 But Amanda Erwin, 46, was a fan on her first try,
even if she got pulled aside for a pat-down. "It’s good. It’s actually kind of smooth," said Erwin, who was on her way from Castle Rock to New
York City. "I like that (the unloading area) is in the round. … And it’s a little less — well, they yelled less," she said, laughing, about the agents.
The bins are about 25 percent larger than the ones
in use on DIA’s other lanes, so even roller bags fit in them.
At the end of the line, empty bins are dropped into a lower-deck conveyor that takes them back to
each individual unloading station.
Passengers whose items are flagged for screening by hand now meet their bin and an agent
at stations past the end of the line. When the agent sets the bin down, it
triggers the X-ray image to pop up on a screen to aid the
review. The Transportation Security Administration has allowed 12
to 15 U.S. "automated screening lanes" using the newer setup, at the airports’
own cost. Larry Nau, TSA’s federal security director for Colorado, said about 140 ASLs now are approved for use nationally.
2.5 million for new equipment manufactured by Scarabee
Aviation Group. The lanes were shoe-horned between existing lanes on the terminal floor’s north end,
adding new capacity. DIA’s terminal is in for more than 3 years of construction. Here’s how it will
play out, and what to expect. 1.8 billion Denver International Airport project,
a question hangs in the air: Is it a good deal?
35 million, Day said. Three and a half years of renovation work that’s now underway will remake
much of the building. 120 million contingency fund that was created as part of that deal.
650 million undertaking will unfold in four waves over 3-1/2 years.
Click the colored squares to see construction phase details.
The emergence of homemade explosives has placed many challenges on aviation security screening.
In an attempt to cope with the threats, the US Department of Homeland Security (DHS) Science and Technology Directorate (S&T)
has been making substantial investments in technology that could be leveraged into the next generation of checked baggage screening equipment.
3.5 million in funding to three new research and development projects designed to improve the threat detection capabilities of current X-ray technologies for checked baggage systems.
"We are addressing current, ongoing, and upcoming capability gaps with a three-pronged approach utilizing the continuous transition of hardware, software, and knowledge," said S&T Checked Baggage Program Manager, Sharene Young.
The projects will be managed by the DHS S&T Checked Baggage Program, which supports TSA requirements to improve overall detection and false alarm performance for explosives detection system technologies.
The first project is an automated threat detection algorithm for improved detection of prohibited items
such as guns and knives. A deep learning 3D convolutional neural network approach will be used
to enhance algorithm development. The goal is to
deploy the automated threat recognition (ATR) algorithm on the
TSA’s checkpoint computed tomography (CT) systems.
The company behind this project is Capture. Another project will produce 12
large field-of-view, high-output count rate X-ray
imaging arrays with high spatial and energy resolution which
can operate at room temperature and be manufactured cost-effectively.
The technology will help eliminate false positives in primary screening lanes
by adding inline X-ray diffraction (XRD). The new technology directly addresses
issues by delivering a better detector with better resolution that can be added in series to existing
primary lanes. The project was presented by DxRay/Rapiscan.
The third project is designed to improve high-speed coded-aperture X-ray scatter imaging (CAXSI) screening to stream-of-commerce rates.
The project focuses
on high-speed data acquisition and maximizing the count rate through the
detector module without compromising other capabilities.
This will allow X-ray machines to be more efficient, with both
better detection and lower energy needs. The project will be developed by
EV Products.
The need for material inspection has risen widely in the industries.
Therefore product launches and technological advancements in the
products are driving the growth of the market.
This system are features high-definition tablet display with user-friendly touch-software for real-time imaging.
Bosello High Technology S.R.L. Others: VJ Technologies, Measurement Control, Smiths Group, CEIA, North Star Imaging Inc.,
PerkinElmer Inc., IXAR, X-ray screening equipment and inspection equipment Associates, LLC, among others.
2016 Teledyne DALSA Inc. with Teledyne ICM, the pioneered companies in the
digital X-ray imaging technology launched its Go-Scan, a portable digital radiography systems at the ASNT Annual Conference, California.
The global industrial radiography equipment market is segmented on the basis of imaging technique
and industry. |
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