Regulatory Filing Requirements and Compliance Processes for medical devices in Japan

Regulatory Filing Requirements and Compliance Processes for medical devices in Japan.jpg

The market for medical devices in Japan is pretty huge. It ranks third in the world after the US and the EU. At just over $ 35 billion a year, which is characterized by an annual growth rate of 3-4 percent; it is far bigger than the markets in the neighborhood, such as China, Malaysia, Singapore and even Australia. Its market for medical devices is comparable to those of Europe and North America. Some of the reasons for this huge market are:

  • The aging population
  • The huge spending power of one of the world’s largest economies
  • The infusion of new technologies into the field of medical devices, which pushes up costs initially
  • The high proportion -nearly a quarter of the entire market -of imported medical devices, especially from the US, which introduce sophisticated, technology-driven products of higher price into the market

Japan’s classification system of medical devices, which classifies these products into Class I, Class II, Class III and Class IV; varies from that of the US or the EU. Adherence to Japanese Industrial Standards, which define industry-wide safety and performance requirements, is mandatory for medical devices.

In addition, the Japanese medical devices market has been undergoing a few major changes. Medical device manufacturers have to deal with strict new package insert requirements. The Marketing Authorization Holder (MAH) system, which deals with licensing rules, have changed, requiring a new MAH License category for In Vitro Diagnostic (IVD) devices. New changes have been made into several other aspects of medical devices. These include:

Medical device manufacturers have to also reckon with expanded scope of third party certifications, and comply with rules for Software as a Medical Device and for transferring pre-market certifications.

Full explanation of the regulatory requirements 

Regulatory Filing Requirements and Compliance Processes for medical devices in Japan1

All these factors make it very important for medical devices that want to enter the Japanese market, to get a thorough understanding of the regulatory requirements. Complete understanding of all these and more will be imparted at a two-day seminar from GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance.

David R. Dills, Regulatory & Compliance Consultant with more than 24 years of hands-on experience and a proven track record within the FDA regulated industry; will be the Director of this seminar. David carries an extensive regulatory and compliance background with Class I/II/III and IVD devices, pharmaceutical operations, and manages activities within the global regulatory and compliance arenas.

 

Please log on to Regulatory Filing Requirements and Compliance Processes for medical devices in Japan to enroll for this highly valuable training session which will put the whole gamut of regulatory requirements for medical devices in Japan in perspective. This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

 

Understanding how to streamline the regulatory process

Regulatory Filing Requirements and Compliance Processes for medical devices in Japan3

By attending this seminar, participants will be able to get a proper grasp of the entire registration and approval process in Japan. They will be able to identify and understand the major changes to medical device registration process in Japan. This will help them to streamline the medical device registration process, which will help them to obtain approval for their product in the most cost-effective and timely manner.

 

At this highly interactive session, the Director will let participants discuss their own device registration and approval process relative to their work-related responsibilities and handling submissions. This will be a very hands-on approach to helping them to review and discuss pain points, challenges and solutions.

David will cover the following areas at this seminar:

  • Which regulatory bodies in the Japanese government are responsible for medical device registration in Japan?
  • In Japan, are medical devices required to be registered before they can be sold?
  • What are the different regulatory classifications for medical devices?
  • What are the different application categories for medical device registration?
  • What does the registration pathway look like for each regulatory classification?
  • What are the document requirements for notification for the various classes of medical devices?
  • What are other requirements that are necessary for approval in addition to the device application?
  • Is local testing (type testing/sample testing) required for registration?
  • When are clinical studies required for registration?
  • Is approval in the Country of Origin required for registration?

 

To join us for more information, get in touch

 

 

 

Top Healthcare Webinars You Can Get for $10

The cost of learning a new skill in regulatory compliance1Used to paying over $250 for a high quality healthcare webinar from a leading expert on the topic from a reputable provider of professional trainings? Let us change your habit! You no longer have to pay this much. So, how much do you think you need to be paying for top healthcare webinars? $200? $150? $100? None of these. All that you have to pay for a top healthcare webinar is $10!

Yes, no spelling errors here. It is indeed $10. That is all you need to pay for a healthcare webinar from GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance. There is a whole list of top healthcare webinars you can get for $10. There are just so many on offer; you will be spoilt for choice:

Healthcare reform is one of the hot areas of healthcare today, what with many regulations that keep coming up from time to time about this critical sector of the economy. This top healthcare webinar you can get for $10 equips you with many facets of the Affordable Care Act, or what we have come to call Obamacare. What impact will it have on employees and employers? Find out through this webinar.

Healthcare is an area in which FMEA applies very strongly. When something goes wrong at the healthcare provider’s location; it throws the whole system out of gear. Carrying out a thorough failure mode and effects analysis is a great antidote to these problems. Want to find out how to do it? This top healthcare webinar you can get for $10 has the answers.

But one question has not been answered yet: Why is GlobalCompliancePanel doing this? Why is it having this offer now? Well, it is because it wants to ensure that the community of regulatory professionals grows, and grows well. Having been in the professional trainings area for ten years now; it feels this is something it needs to do in order to draw more people into the regulatory trainings network. By offering top healthcare webinars you can get for $10; GlobalCompliancePanel wants to contribute its mite to enhancing and expanding the learning community.

Isn’t this offer of top healthcare webinars you can get for $10 the ideal means to growing up in your career? After all, we spend this amount on myriad things that could be of some use to us, but does this use compare with the enormity of the utility a healthcare webinar gives? These top healthcare webinars you can get for $10 each help you climb your professional ladder. This in turn could help your organization make a name as a responsible and ethical provider of quality products. It could earn it a reputation in the market. When you can accomplish all these through top healthcare webinars you can get for $10, what are you waiting for?

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John.robinson@globalcompliancepanel.com

Support@globalcompliancepanel.com

+1-800-447-9407

Don’t miss out! Offer @ $10 – Online Professional Courses

7This is a great deal. What else does one call this offer $10 deal to enhance professional skill from GlobalCompliancePanel? Wait. We are talking about $10, but did we tell you what you get for $10? Did you think it is the cost of registration for the event? Well, be prepared to get proven wrong –for the happiest of reasons. $10 is the price of a single recorded webinar that GlobalCompliancePanel is putting up at this great deal @$10 to enhance professional skills with GlobalCompliancePanel!

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3A rich assortment of courses is available at this great deal @$10 to enhance professional skills with GlobalCompliancePanel. You can choose from trainings that help you with nuances of how to establish a reduce testing program for pharmaceutical and medical device components, where the guru of starting up, developing, implementing, managing, and remediating pharmaceutical and medical device Quality Systems, Howard Cooper, will show how to derive the benefits of systematic reduced testing program include increased compliance, smaller inventory cycles, less testing, less handling, and increased productivity and efficiency.

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John.robinson@globalcompliancepanel.com

Support@globalcompliancepanel.com

+1-800-447-9407

 

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Regulatory compliance, as we all know, is a really vast area of knowledge. With the FDA framing innumerable laws and regulations on every area that it regulates, it is imperative for regulatory professional to show compliance with the regulations. They are doomed if they fail. GlobalCompliancePanel brings hundreds of courses in all the areas of regulatory compliance to help professionals understand how to meet these stringent standards.

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Which universities are pushing the boundaries in life sciences?

If you had to name the branch of university research that has the most tangible impact on mankind’s day-to-day activities, it is likely that the life sciences would be near the top of the list: not many days go by without the announcement of a new drug or gene discovery that has the potential to change lives or tackle disease.

Much of the best research in these fields takes place in the ultra-elite universities that excel in subjects across the board.

But analysis by Times Higher Education of the institutions that make up the World University Rankings reveals that there is a cluster of institutions just below this elite that are particularly strong in the life sciences and in driving forward innovation.

The 120 “life science challengers” tend to pitch much higher in the subject rankings related to clinical research and life sciences, as might be expected, with the bulk of them achieving overall scores in the middle to upper ranges (see below).

Which universities are pushing the boundaries in life sciencesHowever, they also perform very strongly in terms of the citation impact of their research, something that can be credited to their excelling in fields where journal article activity is key. Unlike the “technology challengers” (another cluster in the rankings), they also tend to be older universities, with few having been established less than 50 years ago.

Beyond these similarities though, the factors that drive the individual successes of the institutions are varied. In some cases excellent strategic decisions taken by the university are a factor; in others the local or regional ecosystem for research plays a part.

Sweden, which has five institutions in the list (headed by the medical research specialist Karolinska Institute), is one example where the ecosystem for life sciences appears to be a key factor.

Ulf Landegren, professor of molecular medicine at Uppsala University, another of the Swedish institutions in the list, said that the country had historically excelled in many life science fields, but that it was now taking its performance to another level with the help of collaborative programmes. The Science for Life Laboratory is one such programme – government-funded, it is based in Uppsala and also in Stockholm.

The SciLifeLab, as it is known, allows researchers from across Sweden to use cutting-edge and often expensive technology without paying for the privilege (apart from the costs of “disposables” used in lab work). Companies and scientists based outside Sweden can also use the facilities, but must face the full cost of doing so.

Professor Landegren, who was heavily involved in setting up Uppsala’s SciLifeLab site, said the effect of the scheme “has been that Swedish scientists now have ready access to advanced techniques that they may not themselves have the economy or the skills to set up”.

“Increasingly we see that life science is going the way of physics, in that technology is getting a little too expensive and complicated for individuals to have all the resources they need to answer their research questions so you might as well centralise it,” he explained.

He added that as well as making “generic” technology and techniques available to all Swedish scientists, SciLifeLab went a stage further by also identifying emerging “beyond state-of-the-art” approaches to research and capitalising on them before they spread to other countries and universities.

Access to expensive technology and the latest techniques is a theme carried across to other institutions that make the list.

Ross Coppel, director of research in the Faculty of Medicine, Nursing and Health Sciences at Australia’s Monash University, puts its success down to past strategic decisions to invest properly in the best academic staff and equipment, but also to the skilled technicians who operate facilities.

He said universities’ research strategies “are often very similar and it [success] comes down to your capacity to implement and execute your vision. I think we were in the fortunate position of having the financial resource to do it [and] the determination to do it and it’s worked out for us very well”.

On the role of technicians, he said Monash had focused on their field being a career path in its own right, with good job security and benefits. In return, in terms of testing new techniques and advancing research technology, “we look to them also to be pushing the boundaries of what is achievable”, explained Professor Coppel.

Beyond smaller research nations like Sweden and Australia, the life science challengers cluster is dominated by institutions in the US and UK.

With 35 institutions of the 120 (the UK has 24), the US is out in front, with a number of private institutions excelling in research. Here, the unique position that some American universities occupy – having strong ties to hospitals and the general healthcare system – is an obvious explanation for their success.

Emory University in Atlanta, for instance, is behind the state of Georgia’s biggest healthcare system – not-for-profit Emory Healthcare – while the US’ Centers for Disease Control and Prevention has its headquarters adjacent to the university’s campus. This geographic proximity between researchers and the practical application of their findings has obvious collaborative benefits.

But the university is also keen to stress the importance of its global reach through its success in spinning out research into the healthcare market and its academic links overseas.

David Stephens, vice-president for research at Emory, said that the institution had “realised its greatest success in commercialising research discoveries in the field of infectious diseases. For example, nine out of 10 US HIV/Aids patients, and thousands more globally, are on life-saving drugs discovered at Emory”.

Meanwhile, an effect of its international collaborations can be seen in the recent joint set-up with the University of Queensland – another life science challenger institution – of a multimillion-dollar biotech company developing cancer treatments.

simon.baker@timeshighereducation.com

HIPAA compliance expectations from Small Healthcare Providers

If your small healthcare practice needs to understand how to put a HIPAA compliance program in place or make sure the current program is adequate and can withstand government scrutiny, please join us for this informative and interactive Two-day training course.

For The Health Information Portability and Accountability Act (HIPAA), the Business Associate is a major component. According to HIPAA, a Business Associate (BA) is an organization or a person who works with or provides service to a Covered Entity. A CE is one who handles or discloses Protected Health Information (PHI). This makes a Business Associate any person or entity that is involved in creating, receiving, maintaining or transmitting PHI to a CE for a purpose or activity or function as mandated and regulated by the HIPAA Privacy Rule.

Small businesses struggle with meeting HIPAA requirements

There are specific requirements that small healthcare practices need to put in place and to show that their program is current and meets the regulatory requirements set out in HIPAA. They need to conceive and implement a HIPAA compliance program that meets the requirements set out in this legislation. The compliance program should not only be adequate; it should be robust and resilient enough to withstand HIPAA’s strict scrutiny at various levels.

Helping small healthcare providers with the knowledge and skill needed for meeting HIPAA requirements is the purpose of a two-day seminar that is being organized by GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance. At this seminar, Jay Hodes, who is a leading expert in HIPAA compliance and President of Colington Consulting, which provides HIPAA consulting services for healthcare providers and Business Associates, will be the Director.

Want to get a complete understanding of the requirements that small healthcare providers need to meet to comply with HIPAA requirements? Just register for this learning session by visiting HIPAA compliance expectations from Small Healthcare Providers.

Full explanation of what all a small business provider needs to do

This seminar is particularly created for small healthcare providers who have a difficulty in understanding the HIPAA compliance requirements and meeting them. It will be useful for those of various business sizes, but is primarily focused on the small healthcare provider. Jay will impart the kind of teaching with which organizations will be able to meet all of the HIPAA, HITECH, and Omnibus Rules.

The basis to implementing the requirements of compliance program is to first fully understand them. This is the learning that this seminar will offer. At the end of two days of intense learning that will be interspersed with lively presentations; participants will have inculcated a full grasp of all of the requirements for a comprehensive HIPAA compliance program. They will also have got a clear understanding of the kind of steps that they need to take to mitigate risk.

Steps needed to develop, review and amend HIPAA

The Director will include practical exercises over these two days that will help participants know all that is needed for developing, reviewing, and amending HIPAA policy and procedure. He will equip the participants with a clear roadmap for what needs to be place when it comes to all of the HIPAA regulations.

Over the two days, Jay will cover the following areas:

o  Why was HIPAA created?

o  Who Must Comply with HIPAA Requirements?

o  What are the HIPAA Security and Privacy Rules?

o  What are the Consequences of being a Business Associate

o  What is a HIPAA Compliance Program for a Business Associate?

o  What is a HIPAA Risk Management Plan?

o  What is a HIPAA Risk Assessment?

o  What is the Role of the HIPAA Security Official?

o  What are HIPAA training requirements?

o  What is a HIPAA data breach and what happens if it occurs?

o  What are the penalties and fines for non-compliance and how to avoid them

o  Case Examples of HIPAA Data Breaches

o  Creating a Culture of Compliance

o  Q&A.

Four years of the EU’s Cosmetics Product Regulation

It has been four years since the EU’s Cosmetics Product Regulation (Regulation EC No. 1223/2009), initiated in December 2009, became operational in July 2013. This regulation was considered path breaking when it was introduced because of its comprehensive nature as well as the extent of the shift it signaled from the legislation from which it took off. It was also considered extremely significant because it suggested a regulatory framework that was in alignment with the most modern technologies and methods available during the present times.

Some of the regulatory modules which are structured into the EU’s Cosmetics Product Regulation include important elements aimed at ensuring safety of cosmetic products and accountability from manufacturers, and include points such as:

o  Cosmetic Product Safety Report (CPSR)

o  Product Information File (PIF)

o  Responsible Person (RP)

o  Label information

o  Cosmetovigilance

o  Substance regulations

o  Claims, etc.

Compliance with the safety regulations set out in EU’s Cosmetics Product Regulation is mandatory. This, though, is not easy, considering the severe clauses that the regulation has for ensuring compliance. These are the reasons for which compliance with the EU’s Cosmetics Product Regulation is challenging:

–       In-market control is assigned to EU Member State competent authorities

–       The flow of information between countries is interlinked by the Cosmetic Product Notification Portal (CPNP), which is fed with the information by the demand for pre-market notification of cosmetic products and by ongoing cosmetovigilance procedures put in place with the respective provisions in the CPR

–       The central role in cosmetovigilance applies to the Responsible Person while the access to manufacturers and responsible persons is assured by product labeling provisions

–       EU and non-EU manufactures of cosmetics as well, as the suppliers of cosmetic ingredients, are required to provide data on their chemicals

–       Compliance with the modules requires know-how, diligence and ongoing adjustment to state of the art of knowledge and documentation.

More challenges

In addition, the EU’s Cosmetics Product Regulation presents more challenges for manufacturers of cosmetic products that want to market to any of the countries of the EU:

The EU’s Cosmetics Product Regulation is so expansive that it represents not only the entry requirements for marketing of cosmetics product in the European Union; but is a model framework for many national legislations worldwide. These legislators are given the choice of either adopting a few parts of the EU’s Cosmetics Product Regulation’s modules, or the structure of the Regulation of its predecessor legislation, the Cosmetics Directive, in full. Therefore, companies need to have the knowledge and the skills needed for complying both with the EU’s Cosmetics Product Regulation and other regulatory frameworks.

There is yet another challenge to implementing the EU’s Cosmetics Product Regulation: The safety assessment. Complying with this part of the EU’s Cosmetics Product Regulation requires extensive knowledge and skill of a host of subjects and issues such as toxicology, chemistry, cosmetology and microbiology, apart from that of regulatory affairs and compliance management. This already tough provision has been made even tougher with the final implementation of the ban on animal testing that the EU introduced in March 2013,

As a result of this ban, considerable confusion abounds about the interpretation of the compliance regulations in the various agencies and sectors that the compliance process has to pass through. If alternative tests are carried out, they are not available for all toxicological endpoints that need assessment as part of the EU’s Cosmetics Product Regulation.

Clearing the confusions

This makes compliance with the EU’s Cosmetics Product Regulation as difficult and complicated as one can imagine. A two-day seminar from GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, will offer clarity on the provisions of the EU’s Cosmetics Product Regulation. The complicated parts of the regulation, namely the regulatory modules, will be given a clearer understanding.

The Director of this two-day seminar is Dr. Annelie Struessmann, who is the Technical & Regulatory Director with CONUSBAT Regulatory Services, a provider of internationalization compliance services for Cosmetics, Personal Care, Fine Chemicals and Borderline Industries.

To gain better understanding of this regulation, please visit Four years of the EU’s Cosmetics Product Regulation to enroll. This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

At this session, Dr. Struessmann will explain the provisions of the regulatory modules and supplement this with a description of the latest developments and research results. She will use these to show pathways towards compliance, at which she will use practical examples and experiences gained in the course of performing the necessary compliance steps before and while marketing of cosmetics products in the EU.