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DTSTAMP:20240328T090357Z
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DTSTART:20210208T090000
DTEND:20210209T090000
CLASS:PRIVATE
DESCRIPTION:
\n - Classification systems differ from that of the Unite
d States or European Union in select countries
\n - Medical devices
are classified depending on their risk level
\n - Medical devices mu
st also comply with additional country standards and these standards defin
e industry-wide safety and performance requirements
\n - Regulatory
registration process is defined for China\, Hong Kong\, India\, Japan\, So
uth Korea\, Taiwan\, Singapore and Australia
\n - The regulatory pro
cess from product design to market entry for a new medical device or IVD i
s oftentimes complicated and unclear.
\n - In Asia Pacific\, it can
become difficult to make a clear distinction between your regulatory strat
egy and business strategy.
\n - And Much More...
\n
\n\n
\nWhy should you attend:
\n\n\n - Learn and understand the
entire Registration and Approval Process
\n - Identify and understa
nd the changes to Medical Device Registration Process in select countries<
/li>\n
- Streamline the medical device registration process so that you
can obtain approval for your product in the most cost-effective and timely
manner
\n - Learn how to access new markets and obtain medical devi
ce approval in all the countries listed
\n - Complete your registrat
ion in order to obtain medical device approval as efficiently as possible
while realizing that some markets/countries will be more challenging
\
n - Navigate the regulatory system\, achieve product registration\, and
access the medical market
\n - In a group setting\, review and discu
ss pain points\, challenges and workable regulatory and compliance solutio
ns.
\n - Participants will discuss their own device registration and
approval process relative to their work-related responsibilities and hand
ling submissions
\n
\n\n
\nAreas Covered in the Session:<
/h4>\n\n\n - Which regulatory bodies are responsible for medical dev
ice registration in each country?
\n - Are medical devices required
to be registered before they can be sold?
\n - What are the differen
t regulatory classifications for medical devices?
\n - What are the
different application categories for medical device registration?
\n <
li>What does the registration pathway look like for each regulatory classi
fication?\n - What are the document requirements for notification f
or the various classes of medical devices?
\n - What are other requi
rements that are necessary for approval in addition to the device applicat
ion?
\n - Is local testing (type testing/sample testing) required fo
r registration?
\n - When are clinical studies required for registra
tion?
\n - Is approval in the Country of Origin required for registr
ation?
\n
\n\n
\nWho Will Benefit:
\n\n
This semina
r will provide an overview and in-depth snapshot of the medical device reg
istration and approval process for Asia Pacific and with the corresponding
regulatory authorities. Employees who will benefit include all levels of
management and departmental representatives from key functional areas and
those who desire a better understanding or a "\;refresh"\; overvie
w of the medical device registration process\, including:
\n\n\n Clinical Research Associates\n - Clinical Project Managers
\n
- Regulatory Affairs Professionals
\n - Clinical Investigators an
d Clinical Research
\n - Regulatory Affairs Management
\n - Re
gulatory Affairs Specialists
\n - Regulatory Project Leads/SME'\;
s
\n - Auditors
\n - Compliance Specialists
\n - Clinica
l Affairs
\n - Quality Assurance
\n - Consultants
\n - D
istributors
\n
\n\nDay 1 Schedule
\n\n
\nLecture 1
: \;Medical Device Registration and Approval Process<
/p>\n\n
\n - Introductions and Background
\n - China\, Hong Kon
g\, India\, Japan\, South Korea\, Taiwan\, Singapore and Australia and ove
rview of the pre and post-registration and approval process
\n - Wha
t is the classification scheme for medical devices?
\n - What are th
e registration procedures?
\n - How are devices classified?
\n <
li>How do regulatory requirements differ for domestic vs. foreign manufact
urers?\n - How long does it take to register devices?
\n - Ne
w Registration Pathways for Manufacturers
\n - Revised medical devic
e registration and approval requirements in select countries
\n - Qu
ality management systems (QMS) are streamlined
\n - QMS inspections
with Marketing Authorization Holders and Manufacturers
\n - Key Guid
elines and Resources
\n - Will our clinical studies and testing cond
ucted outside the countries be accepted?
\n
\n\n
\nLecture
2: \;Exercise and Recap of Day 1
\n\n
\n
\n - Interactive Discussions
\n - Review of Regulatory Documents
li>\n
\n\nDay 2 Schedule
\n\n
\nLecture 1: \;Medical Device Registration and Approval Process
\n\n\n
- Medical Device Registration and Approval Process and Recap from Day 1
\n - China\, Hong Kong\, India\, Japan\, South Korea\, Taiwan\, Sin
gapore and Australia and overview of the pre-registration and post-registr
ation and approval process
\n - Documentation required for review an
d approval
\n - Registration and country codes and other requirement
s
\n - In-Country Representative/Marketing Authorization Holders/Aut
horized Representatives
\n - QMS and other requirements
\n - D
ocumentation and Additional Materials for Registration and Approval
\n
- Consultation sessions with Regulatory Authorities\, how to maximize f
oreign clinical data\, and how to expedite product registration
\n - Trends and lessons learned with recent and current registrations
\n <
li>New medical device regulations and approval requirements are released o
n a regular basis sometimes and companies must keep track and current
\n - Responding to inquiries and questions from the Regulatory Authoriti
es/Agencies
\n - Regulatory inspection process
\n
\n\n
\nLecture 2: \;Exercise and Recap of Day 2
\n\n
\n\n - Interactive Discussions
\n - Review of Regulatory
Documents
\n
\n\n
\nLecture 3: \;Debrief/Adjo
urn
\n\n
\n\n - Recap of topics and key discussion
points and take away message
\n - FAQs and latest trends
\n
\n\nDavid R. Dills
\nGlobal Regulatory Affairs &\; Compliance C
onsultant \;
\n \;\nDavid R. Dills\, 
\;Global Regulatory Affairs &\; Compliance Consultant currently provide
s regulatory affairs and compliance consultative services for early-stage
and established Class I/II/III device\, IVD\, biopharmaceutical\, cosmetic
s and nutraceutical manufacturers on the global landscape\, and has an acc
omplished record with more than 27 years of experience in the areas of Reg
ulatory Affairs\, Compliance and Quality Systems. He has been previously e
mployed\, with increasing responsibilities by device manufacturers and con
sultancies\, including a globally recognized CRO and has worked directly w
ith manufacturers engaged in compliance remediation activities involving c
onsent decrees\, CIA'\;s\, warning letters\, and customer generated com
pliance events\, conducts QS\, regulatory\, compliance assessments/audits
and FDA Mock Inspections for State of Readiness. He has been directly invo
lved with constructing\, reviewing\, and remediating regulatory submission
s\, U.S. Agent for OUS companies\, works closely with the key stakeholders
and Agency/Center Reviewers regarding submission meetings and negotiation
s\; clinical affairs/CTM and provides regulatory submissions and post-mark
et project leadership and guidance covering multiple therapeutic and medic
al specialties based on classification. He has a strong background in the
interpretation and applicability of FDA and international regulations\, le
ads activities for the registration and approval process and working with
the Agencies in Asia Pacific\, EMEA and The Americas\, including FDA\, Eur
opean Medicines Agency-EMA\, MHRH\, ANVISA\, PMDA\, MOH\, CFDA\, TGA\, and
Health Canada and works with management on regulatory strategies and plan
s supporting a company'\;s commercialization strategy. He directs and l
eads efforts for PM support involving all phases of the premarketing to po
stmarketing\; establishes Medical Device Single Audit (MDSAP)\, UDI\, and
Digital Marketing/Promotion/Advertising compliance strategies\; lead effor
ts regarding AE/Incident Reporting\, all aspects of Postmarketing Surveill
ance and Vigilance Reporting\; establish QMS and documentation systems for
GxP compliance\; ISO 13485 registration and CE Mark\, Technical File\, De
sign Dossier and CER consultation\; and facilitates multi-country product
registrations and licensing. He recommends action to senior leadership to
ensure effective resolution for manufacturers to achieve sustainable and p
roven compliant systems. Background encompasses broad capabilities in qual
ity systems\; documentation development and remediation\; regulatory overs
ight and governance\; design controls\; CAPA investigations\; GxP training
\; software embedded medical devices/all aspects of SW/SDLC and process va
lidation with compliance oversight\; supplier management\; and demonstrate
s credible experience to optimize business performance through proactive s
trategies to mitigate compliance exposure. Mr. Dills has served on the Fac
ulty Advisory Board for the Pharmaceutical Training Institute\, Editorial
Advisory Boards for \;Software Quality Professional \;and
the Institute of Validation Technology (IVT)\, publisher of the \;Journal of GXP Compliance and Journal of Validation Technology \
;and on the Readers'\; Board for \;Medical Device &\; Diagno
stic Industry \;and \;Medical Product Manufacturing News<
/em> \;and was nominated and accepted for inclusion into the 2005-2006
Strathmore'\;s Who'\;s Who of Professionals. Mr. Dills has authored
and published validation\, regulatory and compliance-related articles\, c
ommentaries and technical guides\, and is an accomplished global industry
presenter. Mr. Dills'\; academic degrees include Environmental Science
and Biology. He is a former Chair and Co- Chair of ASQ'\;s Section 1506
and affiliated with the Biomedical Division\, RAPS\, AdvaMed\, PDA\, ISPE
\, and other industry working groups.
\n
\nPlease contact Marily
n Turner: Phone: +1 929 900 1853  \;Email: marilyn.turner [a] nyevents
list.com for registrations
\n
SUMMARY:Medical Device Registration and Approval Process for the Pacific Ri
m (including India\, Japan\, China\, Singapore\, Australia\, Taiwan\, Hong
Kong\, and other locations)
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SUMMARY:Medical Device Registration and Approval Process for the Pacific Ri
m (including India\, Japan\, China\, Singapore\, Australia\, Taiwan\, Hong
Kong\, and other locations)
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