Legal entity

Guidelines for the new medical device law (Taiwan)

Medical devices were previously governed by the Pharmaceutical Affairs Act. On December 13, 2019, the Legislative Yuan passed the “Medical Device Law” (the “Law”) through the third reading process, separating the governance of these medical devices from the “Pharmaceutical Affairs Law” . This distinction highlights an independent resolution for a more complete regulation system that meets the practical needs of medical device management in order to accelerate their introduction to the market and promote its industrial development. The law entered into force on May 1, 2021 and its relevant rules and standards have been made public. (See appendix for more details)

The law consists of 9 chapters and 85 articles. Its key points are:

I. Regulation of medical device companies

As stipulated in the Pharmaceutical Affairs Act, medical device companies consist of two categories: manufacturers and resellers. The new law made several important improvements to accommodate the trend towards a finer division of the manufacturer. Specifically, he clarified the definition of manufacturer to include the manufacture, packaging, labeling, sterilization and final inspection of medical devices and added to the definition of manufacturer “engage in the design of devices”. medical devices and market the devices under their name ”(article ten). In addition, the law required those involved in the manufacture, import or maintenance of medical devices to recruit technicians according to the type of devices used (Article 15).

The law categorizes resellers as wholesale, retail, import, export, rental and service, and these resellers are required to apply to serve as medical device companies before undertaking such activities. (Articles 11 and 13)

II. Improve the regulation of risk classification before the marketing of medical devices

In principle, medical devices must be the subject of an inspection registration request; It is only after approval and licensing that it can be manufactured and imported. However, the new law simplifies this pre-market review process for low-risk medical devices. Instead of requesting inspection registration, the device list will suffice for several low-risk medical devices. Manufacturers must file an annual declaration of registration with the competent central authority each year to maintain its validity. (Articles 25, 28)

The issuance of licenses for medical devices is flexible as to its period of validity. The maximum validity period is 5 years and extensions can be applied before the expiration date. Each extension must not exceed 5 years. (Article 27).

III. Implementation of regulations on pre-market clinical trials of medical devices

Clinical trial institutions or trial sponsors submit an application for approval to the central authority before any clinical trial. Any adverse event during the trials must be reported to the authority within 7 days of becoming aware of these events. If security risks arise during the trial, it can be suspended or terminated (Articles 37, 38, 39).

To manage the risks, clinical trials on medical devices that carry insignificant risks as announced by the competent central authority are not required to submit requests for approval (Article 37).

IV. Improve post-market supervision on the safety of medical devices

The competent authority announces specific categories and articles of medical devices with restriction of their type of sale or supply in response to various new forms of sale of medical devices (Article 18). With respect to medical devices classified as a specific risk level as announced by the competent authority, medical device companies and medical establishments should establish data on the source and flow of their products to help trace and monitor products on the market (Article 19).

For product safety considerations, the manufacturer of medical devices must establish a quality control system and report to the competent central authority for inspection in order to obtain authorization before proceeding with manufacture (Article 22). Medical devices and their resellers announced by the competent authority must set up a quality distribution system that meets the distribution standards for medical devices, and obtain a distribution authorization before any wholesale, import or export (Article 24) . In addition, a communication protocol should be established for essential medical devices, especially when their manufacture, import ceases or supply is insufficient. (article 34)

To oversee the management of medical devices, taking into account the potential risk of certain medical devices, the competent authority may order medical device companies to execute a safety oversight plan on specified items at a time of their choosing. in order to monitor the safety of medical devices. Medical institutions provide assistance and provide all relevant data (Article 47). In addition, for the safety of its users, as soon as it becomes aware of a probable risk of bodily harm from a medical device, the authorized owner or the registrant of such devices must immediately take corrective measures and preventive measures and inform the competent authority (Article 49).

V. Criminal liability of serious offenders

Those who violate the law will be subject to administrative penalties depending on the nature of the violation, which may include fines; an order requiring corrective action within a limited timeframe; an announcement of the identity, name and details of the infringement of the offender; and license suspension or withdrawal (Articles 64 to 71). The following penal sanctions may apply to persons in serious breach:

1. Those who manufacture or import defective medical devices which lead to a misdiagnosis, or devices containing toxic or dangerous substances which cause bodily harm may be sentenced to a maximum of 5 years imprisonment, criminal detention or imprisonment. fine of up to NT $ 50 million, or both. Negligent violations can be sentenced to a maximum of 3 years imprisonment, criminal detention or a fine of up to NT $ 10 million, or both. (Article 60, paragraphs 1 and 3)

2. Those who knowingly sell, supply, transport, store, trade, transfer or display with the intention of selling defective medical devices may be sentenced to a maximum of 3 years imprisonment, criminal detention or a fine of up to NT $ 10 million. , or both. Negligent violations can be sentenced to criminal detention or a fine of up to NT $ 1 million, or both. (Article 60, paragraphs 2 and 4)

3. Anyone who abuses or uses without authorization the name, instructions or labels of a legitimate medical device can be sentenced to up to 5 years imprisonment, criminal detention or a fine of up to $ 20 million. NT, or both. Those who knowingly import, sell, supply, transport, store, trade, transfer or display with the intention of selling medical devices while being aware of the above violations may be sentenced to a maximum of 2 years imprisonment, detention criminal or fine of up to NT $ 10 million, or both. (Article 61)

4. Anyone attempting to sell or supply, manufacture or import unapproved medical devices or unregistered devices that should have been registered; and those who knowingly sell, provide, transport, store, trade, transfer or display with the intention of selling while being aware of the above violations may be sentenced to a maximum of 3 years imprisonment, criminal detention or a fine of up to NT $ 10 million, or both. (article 62)

5. In the event that those who, in the exercise of their duty, have violated the aforementioned offenses are the representative, agent, employee or any other member of the personnel of a legal person or a natural person , in addition to the penalties imposed on the offender, said legal / natural person will be liable to a maximum of ten times the fine provided for in all articles. (Article 63)

Annex: Compilation of relevant sub-laws authorized under the Act

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Of the. Supreme Court drops risky precedent over direct shareholder claims

A person enters the Delaware Supreme Court in Dover, Delaware, United States, June 10, 2021. REUTERS / Andrew Kelly

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(Reuters) – It is a bold strategy to argue in a nonsuit motion that the binding precedent is bogus and should be overturned. Bold too? Arguing that the precedent can be rejected in an interlocutory appeal, even before there is a decision on the merits of the case.

However, this is what Weil, Gotshal & Manges proposed last year at Delaware Chancery Court, where its client, Brookfield Asset Management Inc, was facing claims for breach of duty on the part of shareholders of TerraForm Power Inc.

The shareholder lawsuit, as I will explain, was based entirely on the 2006 Delaware Supreme Court decision in Gentile v. Rossette. Gentile allowed minority shareholders, in limited circumstances, to bring direct claims against majority shareholders instead of suing on behalf of the company in a more procedurally complex derivative claim.

by Weil motion to dismiss Brookfield’s lawsuit argued that the Supreme Court’s Gentil precedent led to confusion and inconsistency. The decision should be “dismissed,” the brief said, “including, if necessary, via an interlocutory appeal.”

This is exactly how the litigation unfolded. Last October, Vice-Chancellor Sam Glasscock refuse Brookfield’s motion to dismiss, citing Gentile even as he acknowledged “lingering uncertainty as to whether (the ruling) remains good law.” Weil asked Glasscock to certify an interlocutory appeal to resolve this uncertainty. The Vice Chancellor sent the appeal to the Delaware judges.

And Monday, at Brookfield Asset Management Inc. v. Rosson, the Delaware Supreme Court unanimously overturned its own precedent in Gentile, ruling that the 2006 ruling created a contradictory and unnecessary exception to the test that establishes whether shareholder claims are direct or derivative.

The decision means that shareholders can no longer directly sue controlling shareholders for diluting their stock value and voting rights. These claims, the court concluded, can only be made under the Supreme Court’s 2004 test in Tooley v. Donaldson, Lufkin & Jenrette Inc because the harm to individual shareholders arises from the harm done to the company, and any recovery for shareholders would flow from the recovery of the company.

The 2006 Nations Court ruled that the exception it created – allowing minority shareholders to bring direct claims against controllers who act to expand their ownership – “fits perfectly into… Tooley”. In Monday’s opinion overthrowing Gentile, the Delaware judges said the 15 years since have shown that “the ‘fit’ is not that ‘comfortable.’

“We do not intend to disrespect any previous panel of this tribunal,” wrote Judge Karen Valihura. “On the contrary, we recognize that the law must evolve through trial and error, through the tests of time and practical application.”

Monday’s ruling ends the case against Weil Gotshal’s client. Shareholders alleged that in 2018, the Brookfield entities underpaid the TerraForm shares they acquired in a $ 650 million private placement that increased Brookfield’s stake in the company. green energy from 51% to 63.5%. A Brookfield entity acquired the remaining public shares in 2020, depriving minority shareholders of the right to bring derivative actions arising from the private placement. Thus, the only chance of recovery for the plaintiffs was a direct lawsuit against Brookfield.

The Delaware Supreme Court ruling not only banned direct shareholder claims under Gentile, but also rejected their alternative argument for direct ownership based on interference with their voting rights. The judges said the specific facts of the case did not support the theory of voting rights.

Shareholder lawyers Steven Purcell and Douglas Julie of Purcell Julie & Lefkowitz did not respond to my email question about the ruling.

Weil Gotshal’s termination brief in the Brookfield case relied heavily on a concurring opinion from then-Chief Justice Leo Strine in 2016 El Paso Pipeline GP Co LLC v. Brinckerhoff. By this time, Chancellery Court justices had begun to expand the limits of the Supreme Court’s ownership interest in Gentile, allowing shareholders to bring direct dilution claims against board members as well as controlling shareholders, believing that it made no sense to keep controlling shareholders at a higher than corporate directors.

El Paso involved extremely unusual facts. Shareholders arguing derivative claims won a first-instance ruling that found the board of directors approved a deal favoring the controlling general partner of the company. After the trial, however, the plaintiffs lost the quality of their derivative claims when the limited partnership was acquired in a merger.

The trial judge concluded that the shareholders could continue to advance their theory as a direct claim under Gentile. The Delaware Supreme Court overturned the decision, ruling that Gentile could not be extended beyond the particular circumstances of this case, in which minority shareholders would have lost both economic value and voting rights due to the actions of the controlling shareholder.

In a deal, Strine said Gentile should be thrown out completely, though he agreed the El Paso affair didn’t present the opportunity squarely. Gentile, he wrote, is “a puzzling decision, which blurs the clarity of our law in an important context,” he wrote. The precedent “cannot be reconciled with the heavy weight of our precedent,” Strine said, and purports to fill a loophole in Delaware law that is already filled by case law allowing shareholders to sue board members directly. for transactions that transfer control of a company to a majority shareholder.

“Gentile undermines the clarity and consistency that Tooley brought to determining which claims are derived from,” Strine wrote.

Weil, who declined to make a statement on Monday’s ruling, acknowledged that the Brookfield case presented an opportunity that had eluded the Delaware Supreme Court in the 2016 El Paso case. The Brookfield facts matched perfectly with those of Gentile. It was an opportunity for the court, Brookfield told the Delaware judges, to set aside the precedent that had so troubled the former chief justice.

“Practitioners and jurists have argued that the good guys should not remain a good law, and this court’s decision to clarify and harmonize the law will have no surprising or unsettling effect,” Weil argued in his brief. final of the Supreme Court. “On the contrary, the elimination of the doctrine of the status of the Gentiles will promote a more consistent and sensible application of Delaware law. “

The judges accepted. Every now and then when you swing towards the fences you manage to hit a grand slam.

The opinions expressed here are those of the author. Reuters News, under the principles of trust, is committed to respecting integrity, independence and freedom from bias.

Our standards: Thomson Reuters Trust Principles.

The opinions expressed are those of the author. They do not reflect the views of Reuters News, which, under the principles of trust, is committed to respecting integrity, independence and freedom from bias.

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Ryan named one of the 50 Fastest Growing Companies in North Texas for the third year in a row by the Dallas Business Journal

DALLAS – (COMMERCIAL THREAD) –Ryan, one of the world’s leading providers of tax services and software, was recently named to the 2021 edition Dallas Business Journal The Middle Market 50 list, which recognizes North Texas’s fastest growing mid-market companies. This is the third consecutive year that the firm has appeared on this list.

“Our story started with just two team members and one client. Today, we are the preferred tax provider for many Fortune 100 companies operating globally, ”said Ryan President and CEO G. Brint Ryan. “I hope our history of growth and success will inspire future expanding businesses to use the great city of Dallas as a starting point to expand globally.”

The Middle Market 50 list is based on revenue growth over a three-year period for companies with annual sales between $ 10 million and $ 1 billion. The ranking is established from the applications submitted directly to the Dallas Business Journal and through research using publicly available information.

The full 2021 Middle Market 50 list is available on the Dallas Business Journal website.

About the Dallas Business Journal

Founded in 1977, the Dallas Business Journal is the premier source of local business information, research and events in the Dallas / Fort Worth area. The publication brings value to its members by helping them grow their businesses, earn money and grow their careers through a comprehensive set of vehicles, which include print, digital and events. The publication is a division of American City Business Journals, the nation’s largest publisher of trade publications. It is owned by Advance Publications, a private publishing company that also owns Condé Nast magazines and Newhouse newspapers.

About Ryan

Ryan, a global provider of award-winning tax software and services, is the world’s largest firm dedicated exclusively to corporate tax. With global headquarters in Dallas, Texas, the firm provides an integrated suite of federal, state, local and international tax services on a multi-jurisdictional basis, including tax recovery, advisory, advocacy, and compliance services. and technology. Ryan is a nine-time recipient of the International Service Excellence Award from the Customer Service Institute of America (CSIA) for his commitment to world-class customer service. Reinforced by the dynamics myRyan widely recognized as the most innovative work environment in the tax services industry, Ryan’s multidisciplinary team of more than 3,000 professionals and associates serve more than 18,000 clients in more than 60 countries, many of them of the world’s largest Global 5000 companies. More information about Ryan can be found at “Ryan” and “Company” refer to the global organizational network and may refer to one or more of Ryan International’s member companies, each of which is a separate legal entity.

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US SEC Warns Investors About Risks Associated With Certain Chinese Business Entities

WASHINGTON, Sept. 20 (Reuters) – The United States Securities and Exchange Commission (SEC) issued its latest warning on Monday to those seeking to invest in Chinese companies listed in the United States.

In an investor alert, the SEC detailed the potential risks of investing in companies listed in the United States that have contracts with but without control over a Chinese entity, known as a variable interest entity ( LIFE). This is the agency’s most recent move to address concerns that Chinese companies are flouting US market access rules.

In July, the agency said it would not allow Chinese companies to raise funds in the United States unless they fully explain their legal structures and disclose the risk of Beijing interfering in their business. Earlier this year, the agency began rolling out a new law, aimed at China, that would kick foreign companies off U.S. stock exchanges if they fail to comply with U.S. auditing standards.

According to the SEC, these companies listed in the United States often have a subsidiary in China that was formed to enter into contractual agreements with the China-based VIE. Contracts can include powers of attorney, equity pledge agreements and exclusive services or business cooperation agreements.

The VIE structure is typically used because of restrictions Beijing places on non-Chinese ownership of companies in key industries in China, the SEC said. By selling stocks to US investors, companies raise capital from US investors without distributing ownership of those companies to them.

The SEC has warned investors that they are at risk if Beijing determines that they violate Chinese law, may be subject to Chinese jurisdiction for the performance of any contract, and may be affected by conflicts of interest between the owners of the entity and the US shareholders.

Reporting by Chris Prentice; Editing by Aurora Ellis

Our standards: Thomson Reuters Trust Principles.

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WheelsEMI Raises $ 35-40 Million To Enter Used Two-Wheeler Market With Bike Bazaar, Auto News, ET Auto

The company aims to grab a pie of Rs 48,800 crore in the used two-wheeler market with the Bike Bazaar customer interface

Mumbai: WheelsEMI Ltd to Raise $ 35-40 Million in C-Series Funding to Expand and Reorganize Business From Just a Used Two-Wheeler Financier to an End-to-End Supplier used two-wheelers in the country. The company aims to grab a pie of Rs 48,800 crore used in the two-wheeler market with the Bike Bazaar customer interface.

ET learns that the company has so far raised over $ 31 million through Series A and B and is now in the process of raising an additional $ 35-40 million through Series C. The company will rebrand its front line -end Bike Bazaar from Wheels. EMI, while the legal person can continue to operate under the same name.

Bike Bazaar plans to sell, service and finance used two-wheelers at 263 outlets in fiscal year 22, with a plan to expand to over 1,100 outlets in three years , thus seizing a share of the entire life cycle of a second-hand two-wheeler in relation to financing. there currently. The main focus will be on cities and towns of level 2, 3.

K Srinivas, co-founder and managing director of WheelsEMI, says the current used two-wheeler market is very fragmented and affected by the lack of transparency. Bike Bazaar aims to bridge this gap and participate in the entire life cycle of ownership of a used two-wheeler – buy, sell, finance, maintain.

.. We intend to use our unique offline marketplace for tier two and tier three cities. We expect to see half a million bikes via our platform by FY25K Srinivas, Co-Founder and Managing Director, WheelsEMI

“According to our estimate, the second-hand sector is around 90 L of vehicles per year, mainly concentrated in the 10 main urban centers. We believe this number is very low due to the fragmented nature of retail offerings and the lack of trust between buyers and sellers. We intend to use our unique offline marketplace for Tier two and Tier 3 cities. We expect to see half a million bikes on our platform by FY25 ”, Srinivas added.

The company has so far raised funds from Elevar Equity and Faering Capital, with the new round of funding the company aims to grow faster with an accelerated need for personal mobility in the pandemic-stricken world.

WheelsEMI entered the market about four and a half years ago with the intention of reaching unbanked customers with convenient refund options. Today, the company has onboarded over 1.8 Lakh clients and has over 500 crore in assets under management, which it intends to grow to $ 1 billion over the next five years – to meet to clients looking for financing in rural areas, used two-wheelers, electric two-wheelers and offering an end-to-end solution in the used two-wheeler segment through Bike Bazaar.

The founding team of Srinivas and co-founder V Karunakaran have deep domain knowledge and a unique blend of experience, industry knowledge, operational experience, maturity and cohesion resulting from past collaboration. in the sale and financing of two-wheelers at Bajaj Auto. The team has complementary 360-degree expertise in two-wheelers, spanning marketing, products, distribution, channels, financing, operations and technology.

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With the latest investment, CARS24 will expand its global presence, further develop its cars, bikes and finance businesses in India, and continue to invest in technology that delivers the best possible customer experience, the company said.

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QCB notes that consumer and business delinquency is on the decline …

(MENAFN – Gulf Times) Consumer and business delinquency had declined year over year in 2020 despite the Covid-19-induced lockdown in place for most of the year, according to the Central Bank of Qatar (QCB).

In its 2020 annual report, the QCB said the Qatar Credit Bureau reported that consumer delinquency (over 90 days late) had decreased to 5.97% at the end of December 2020 from 6.14% the previous year.

Consumer credit stood at QR 253.33 billion at the end of 2020 against QR 253.53 billion the previous year.

In the case of commercial delinquency (more than 90 days late), the credit bureau indicated that it had fallen to 4.75% at the end of December 2020 against 4.95% a year ago.

Trade credit (excluding government entities and companies not registered with the Ministry of Trade and Industry) amounted to QR 261.72 billion, showing an annual growth of 6.09% in 2020.

Although 2020 saw the emergence of a unique set of challenges due to the Covid-19 pandemic, the QCB said the credit bureau’s services continued without any disruption, mainly due to its technological advancements. and its global standards.

The bureau issued a total of 402,127 credit reports, of which 86% or 347,821 were consumer credit reports and the remaining 14% or 54,306 were commercial credit reports in 2020, up from 461,313 (428,316 and 32,997) the previous year.

The bureau had issued 369,408 credit reports (including “dishonor check reports launched in September 2020) to member institutions during the review year.

“There have been 69,076 member-generated non-compliance check reports from its launch date until December 31, 2020,” the report says.

The credit bureau had issued 33,079 self-investigation credit reports to consumers in 2020 compared to 38,461 the previous year.

He accepted self-investigation credit report requests via online inquiries and provided the reports to customers via QPost.

The QCB annual report indicates that the credit bureau has up to 26 members from both banks and non-banks.

The office, which has completed 10 years of operation, provides accurate and comprehensive credit information, which helps overcome the risk management challenges faced by its member institutions.

“The Qatar Credit Bureau is constantly striving to add new members from different economic sectors as well as to design new electronic products, technology applications and services for the members of the credit bureau,” says the QCB annual report.

As an authorized Local Operating Unit (LOU) of the Global Legal Entity Identifier Foundation (GLEIF), Qatar Credit Bureau provides LEI services to consumers to create new LEI / update LEI information / renew LEI on an annual basis / transfer LEI from another LOU to QCB’s LOU online system.

LEI accounts of 49 companies are with the Qatar credit bureau as of December 31, 2020, which includes 28 new LEI accounts opened by companies through the office in 2020.


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