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Asia Regulatory Roundup: India Designates Five Medical Device Testing Labs

Posted 12 June 2018 | By Nick Paul Taylor 

Asia Regulatory Roundup: India Designates Five Medical Device Testing Labs

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
 
India Designates 5 Sites as Central Medical Device Testing Laboratories
 
India has picked five sites to serve as central medical device testing laboratories. The facilities will test and evaluate medical devices to support the implementation of legislation that came into force at the start of the year.
 
Officials have chosen the National Institute of Biologicals (NIB) in Noida, three central drugs testing sites and a regional drugs testing laboratory in Guwahati as the medical device facilities. Each site will specialize in different categories of medical devices, giving India access to the breadth of expertise needed to oversee the technologically diverse sector.
 
The government has assigned the NIB to handle a range of types of device, including glucose test stips and in-vitro diagnostics for HIV and other infectious diseases. In contrast, the central drugs testing laboratory in Chennai will only handle condoms.
 
Dividing up the testing responsibilities marks another step forward for India’s push to better regulate medical devices. India’s National Health Systems Resource Centre established basic requirements for the laboratories in collaboration with the World Health Organization in 2015. That led to the law that came into force in January, which formalized the features and responsibilities of the laboratories.
 
The five chosen laboratories will retain their designations indefinitely, provided they comply with certain requirements. The government can suspend or revoke the registrations of laboratories that fail to comply with the conditions of their approvals.
 
Gazette Notification
 
TGA Relaxes Scrutiny of Notified Bodies Following Changes in EU
 
The Therapeutic Goods Administration (TGA) of Australia has relaxed its scrutiny of certain notified bodies. TGA took the step after concluding increased oversight of the organizations in the European Union has mitigated concerns about the reliability of the medical device assessment bodies.
 
Australian officials began applying extra scrutiny to eight European notified bodies in 2014 following a probe by British medical journal The BMJ. The BMJ investigation found notified bodies “accepted low levels of evidence on the effectiveness and safety of high risk devices” and compromised their independence by advising manufacturers on how to navigate the regulatory process. TGA, which uses European CE marking in its regulatory process, responded by adding audit requirements.
 
Now, following the overhaul of the EU notified body system, TGA has decided the extra scrutiny is no longer required. TGA pointed to the EU’s de-designation of some notified bodies and redefining of the designations of others as changes that have given it the confidence to stop applying increased audit requirements. The extra TGA audit requirements applied to applications that used supporting evidence from eight notified bodies named in the BMJ’s report.
 
The action brings almost four years of additional TGA scrutiny to an end.
 
TGA Notice
 
TGA Prepares Industry for end of Orphan Drug Transition Arrangements
 
TGA is preparing to end the transition arrangements that have applied to its orphan drug program for the past year. Once the transition period ceases at the end of the month, orphan drug designations determined before 1 July 2017 will no longer be valid.
 
Companies affected by the change will not benefit from perks of the orphan drug program, such as the waiving of registration fees. To receive these benefits, sponsors will need to reapply through the new program and under its revised eligibility criteria. Successful applicants will have orphan drug status for six months, beyond which the designation will lapse unless they request a six-month extension.
 
TGA came up with this new way of working through public consultations in 2015 and 2016 but opted against a hard implementation of the revised program in 2017. Such an immediate switch would have rendered all existing orphan drug designations void. The 12-month transition avoided that situation by giving companies time to move to the new regime.
 
Orphan drug designations determined after 1 July 2017 are unaffected by the end of the transition period.
 
TGA Notice
 
China Outlines Action Plan to Combat Spread of Harmful Information Online
 
China’s State Administration for Market Regulation (SAMR) has detailed how it hopes to stop harmful information about drugs from spreading online. SAMR will step up the publication and promotion of facts designed to counter falsehoods and the investigation of the sources of harmful information.
 
The umbrella organization, which houses the State Drug Administration, will perform the activities as part of a six-month push to create a more honest, trustworthy and fair online marketplace in China.
 
SAMR is focusing the push on advertising and other online information with the most potential to harm people and society, leading it to identify the medical and pharma sectors as key hotspots. The spread of misinformation in these fields can cause harm by deterring the use of effective products, such as vaccines, and encouraging the consumption of spurious treatments.
 
Recognizing this, SAMR plans to investigate and deal with the sources of misinformation and counter perceived falsehoods with its own publications. In parallel, SAMR will encourage online businesses to self-regulate, for example by prohibiting the sale or promotion of certain types of goods and services.
 
The activities are central parts of a broader, multi-industry strategy to supervise online activities. In making medicines and pharmaceuticals an important pillar of the strategy, SAMR has echoed the approach it is taking to the enforcement of fair competition rules. In both cases, SAMR is running a concerted, six-month campaign that sees the medical and pharma sectors as key battlegrounds. 
 
SAMR Notice (Chinese)
 
India Adds OPPI to List of Attendees at Quarterly Industry-Regulator Meetings
 
Indian regulators have added the Organisation of Pharmaceutical Producers of India (OPPI) to the list of bodies eligible to participate in a drug association forum. Drug Controller General of India (DCGI) Eswara Reddy proposed the forum earlier this year to encourage discussions between regulators and industry, but left OPPI off the list of attendees.
 
Three months later, OPPI has joined the list of organizations cleared to send two representatives to the quarterly meetings with Reddy and other Central Drugs Standard Control Organization (CDSCO) officials. The meetings will give key trade groups regular, formal access to regulatory leaders.
 
The OPPI acceptance notice implicitly suggests the Association of Regulatory Affairs Professionals (ARAP) has failed to persuade the DCGI to include it in the meetings. ARAP sent Reddy a letter asking to participate in the quarterly gatherings shortly after news of the program emerged. However, so far, OPPI is the only organization to be added to the original list of six industry bodies. 
 
CDSCO Notice
 
Other News:
 
Canon Medical Systems is voluntarily recalling magnetic resonance imaging systems from China. The action follows the discovery that the devices may display a specific absorption rate (SAR) that is lower than the actual value. SAR measures the rate at which the body absorbs energy. Some patients experience physiological stress above certain SAR levels. CFDA Notice (Chinese)
 
Abbott Medical Australia has issued a hazard alert about some of its implantable cardioverter defibrillators and cardiac resynchronisation therapy defibrillators. The devices are at risk of premature battery depletion and could theoretically be accessed by unauthorized users. Abbott is updating the firmware of the devices to address both issues. TGA Notice
 
The Indian government has published changes to the Drugs and Cosmetics Rules, 1945, and brought them into force. Gazette Notification
 
TGA has detailed the fees and charges that will apply from 1 July. TGA Document

Categories: Regulatory News

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