The document discusses key aspects of the proposed Therapeutic Products Bill as it relates to medical devices. It provides an overview of the purpose and design of the bill, definitions of key terms like "therapeutic product" and "medical device", risk classification of devices, and conformity assessment procedures. It notes that the bill is intended to regulate medical devices across their lifecycle from design and development to supply and post-market activities like adverse event reporting. It also outlines different proposed approval pathways for medical devices.
Devices Sponsor Information Day: 0 - Developments in medical device regulationTGA Australia
Presentations by TGA and Industry (combined) to help sponsors and manufacturers better understand the regulation of medical devices and in-vitro diagnostic medical devices
TGA presentation: AusMedtech, 24 May 2017 TGA Australia
This presentation outlines reforms to the device regulatory system following the Expert Panel Review of Medicines and Medical Devices Regulation, reforms to the in vitro diagnostic devices (IVD) regulatory framework, reforms to the European and IVD system and the TGA's new Clinical Evidence Guidelines.
The Medical Device Regulations 2012, the subsidiary legislations under the Medical Device Act 2012 (Act 737), has been approved by the Malaysian Minister of Health and has been published in the Gazette on 31st December 2012. The Regulations will come into operation simultaneously with Act 737 on 1st July 2013. And as specified in Act 737 a transition period of two years for medical device registration and one year for establishment licensing will be given to the industry before it is fully enforced.
mHealth Israel_Digital Health Regulation and the FDALevi Shapiro
Presentation by Bethany Hills, Partner, Mintz Levin: Digital Health Regulation and the FDA. Includes overview of the 21st Century Cures Act, Definition of a medical device, device approval basics, software as a Medical Device (SaMD), FDA Digital Health Activities, mobile medical applications, regulated mobile medical applications, Enforcement discretions of MMA, Clinical Decision Support, 3060 Clarifying Health Software Regulation, Classification Process,
Presentation: Regulatory affairs - The Australian and International landscapeTGA Australia
With local regulatory reforms and reactions to critical global events manifesting in more regulatory shifts, it has been hard to keep up with progress lately. This session provides an opportunity to hear directly from key regulators about their thoughts on the current and future regulatory environment and how it is evolving in response to these global shifts and the multitude of other challenges faced by regulators.
Devices Sponsor Information Day: 0 - Developments in medical device regulationTGA Australia
Presentations by TGA and Industry (combined) to help sponsors and manufacturers better understand the regulation of medical devices and in-vitro diagnostic medical devices
TGA presentation: AusMedtech, 24 May 2017 TGA Australia
This presentation outlines reforms to the device regulatory system following the Expert Panel Review of Medicines and Medical Devices Regulation, reforms to the in vitro diagnostic devices (IVD) regulatory framework, reforms to the European and IVD system and the TGA's new Clinical Evidence Guidelines.
The Medical Device Regulations 2012, the subsidiary legislations under the Medical Device Act 2012 (Act 737), has been approved by the Malaysian Minister of Health and has been published in the Gazette on 31st December 2012. The Regulations will come into operation simultaneously with Act 737 on 1st July 2013. And as specified in Act 737 a transition period of two years for medical device registration and one year for establishment licensing will be given to the industry before it is fully enforced.
mHealth Israel_Digital Health Regulation and the FDALevi Shapiro
Presentation by Bethany Hills, Partner, Mintz Levin: Digital Health Regulation and the FDA. Includes overview of the 21st Century Cures Act, Definition of a medical device, device approval basics, software as a Medical Device (SaMD), FDA Digital Health Activities, mobile medical applications, regulated mobile medical applications, Enforcement discretions of MMA, Clinical Decision Support, 3060 Clarifying Health Software Regulation, Classification Process,
Presentation: Regulatory affairs - The Australian and International landscapeTGA Australia
With local regulatory reforms and reactions to critical global events manifesting in more regulatory shifts, it has been hard to keep up with progress lately. This session provides an opportunity to hear directly from key regulators about their thoughts on the current and future regulatory environment and how it is evolving in response to these global shifts and the multitude of other challenges faced by regulators.
This presentation provides an overview of proposals for implementation of several reform initiatives relevant to prescription medicines, including expedited pathways for registration, enhanced post-market monitoring, variations to registered medicines, work sharing with comparable overseas regulators, the use of overseas assessment reports, and reforms to the orphan drug programs. The information session was held ahead of formal public consultations to provide an early view of the reform proposals to those stakeholders who will be most directly involved in the design of the new regulatory arrangements.
TGA Presentation: What’s happening in regulation?TGA Australia
This presentation provides an overview of the Government's response to the Expert Panel Review of Medicines and Medical Devices, with an emphasis on complementary medicines changes.
GHTF group 1 is about pre market evaluation .This ppt includes brief about the group 1 , about ghtf , what it includes , study groups , definitions , classification and its rules
TGA Presentation: TGA focus and wrap up - What we've done, and what we still ...TGA Australia
An overview of the TGA's implementation of the recommendations made in the Review of Medicines and Medical Devices Regulation and other reforms for the IVD framework
A guideline on medical devices designed internationally for harmonization.
As the site access is unavailable have managed the data for easy access of the details for the Regulatory affairs aspirants of Masters of Pharmacy
Digital Therapeutics Regulatory Process, Update and TrendsInsights10
The market for digital therapeutics (DTx) is expanding tremendously, aided by the increased popularity of decentralized medicine that the pandemic brought about. The global market for DTx was predicted to be worth $3.35 billion in 2021 and would grow to $12.1 billion by 2026. To get a report in detail, contact us at - info@insights10.com
Spotlight on MMDR Further Reviews and Advertising ReformsTGA Australia
An overview of reform initiatives relating to low risk therapeutic goods and the scheduling policy framework arising from the Review of Medicines and Medical Devices Regulation.
TGA Presentation: TGA’s Role in Clinical Trials Regulation and AdministrationTGA Australia
An overview of supplying ‘unapproved’ therapeutic goods in clinical trials, Clinical Trial Notification (CTN) and Clinical Trial Exemption (CTX) Schemes, TGA and Stakeholders Responsibilities, Safety reporting and other regulatory requirements, Clinical trials FAQs, and the Australian Clinical Trials Handbook update
Quorum Review IRB presented a live webinar in September 2014 covering the details of IRB review for medical device studies and their special considerations.
Nutritional Labeling And Clinical Investigation And Evaluation Of Medical Dev...gauravpatil327512
Regulatory Aspects of Food and Nutraceuticals : "Nutritional Labeling And Clinical Investigation And Evaluation Of Medical Devices And IVDs Recommended Dietary Allowances in Europe "
The Therapeutic Goods Administration or TGA is the regulatory body for therapeutic goods in Australia.
The TGA is responsible for conducting assessment and monitoring activities to ensure that therapeutic goods available in Australia are of an acceptable standard.
The Gram stain is a fundamental technique in microbiology used to classify bacteria based on their cell wall structure. It provides a quick and simple method to distinguish between Gram-positive and Gram-negative bacteria, which have different susceptibilities to antibiotics
Muktapishti is a traditional Ayurvedic preparation made from Shoditha Mukta (Purified Pearl), is believed to help regulate thyroid function and reduce symptoms of hyperthyroidism due to its cooling and balancing properties. Clinical evidence on its efficacy remains limited, necessitating further research to validate its therapeutic benefits.
This presentation provides an overview of proposals for implementation of several reform initiatives relevant to prescription medicines, including expedited pathways for registration, enhanced post-market monitoring, variations to registered medicines, work sharing with comparable overseas regulators, the use of overseas assessment reports, and reforms to the orphan drug programs. The information session was held ahead of formal public consultations to provide an early view of the reform proposals to those stakeholders who will be most directly involved in the design of the new regulatory arrangements.
TGA Presentation: What’s happening in regulation?TGA Australia
This presentation provides an overview of the Government's response to the Expert Panel Review of Medicines and Medical Devices, with an emphasis on complementary medicines changes.
GHTF group 1 is about pre market evaluation .This ppt includes brief about the group 1 , about ghtf , what it includes , study groups , definitions , classification and its rules
TGA Presentation: TGA focus and wrap up - What we've done, and what we still ...TGA Australia
An overview of the TGA's implementation of the recommendations made in the Review of Medicines and Medical Devices Regulation and other reforms for the IVD framework
A guideline on medical devices designed internationally for harmonization.
As the site access is unavailable have managed the data for easy access of the details for the Regulatory affairs aspirants of Masters of Pharmacy
Digital Therapeutics Regulatory Process, Update and TrendsInsights10
The market for digital therapeutics (DTx) is expanding tremendously, aided by the increased popularity of decentralized medicine that the pandemic brought about. The global market for DTx was predicted to be worth $3.35 billion in 2021 and would grow to $12.1 billion by 2026. To get a report in detail, contact us at - info@insights10.com
Spotlight on MMDR Further Reviews and Advertising ReformsTGA Australia
An overview of reform initiatives relating to low risk therapeutic goods and the scheduling policy framework arising from the Review of Medicines and Medical Devices Regulation.
TGA Presentation: TGA’s Role in Clinical Trials Regulation and AdministrationTGA Australia
An overview of supplying ‘unapproved’ therapeutic goods in clinical trials, Clinical Trial Notification (CTN) and Clinical Trial Exemption (CTX) Schemes, TGA and Stakeholders Responsibilities, Safety reporting and other regulatory requirements, Clinical trials FAQs, and the Australian Clinical Trials Handbook update
Quorum Review IRB presented a live webinar in September 2014 covering the details of IRB review for medical device studies and their special considerations.
Nutritional Labeling And Clinical Investigation And Evaluation Of Medical Dev...gauravpatil327512
Regulatory Aspects of Food and Nutraceuticals : "Nutritional Labeling And Clinical Investigation And Evaluation Of Medical Devices And IVDs Recommended Dietary Allowances in Europe "
The Therapeutic Goods Administration or TGA is the regulatory body for therapeutic goods in Australia.
The TGA is responsible for conducting assessment and monitoring activities to ensure that therapeutic goods available in Australia are of an acceptable standard.
The Gram stain is a fundamental technique in microbiology used to classify bacteria based on their cell wall structure. It provides a quick and simple method to distinguish between Gram-positive and Gram-negative bacteria, which have different susceptibilities to antibiotics
Muktapishti is a traditional Ayurvedic preparation made from Shoditha Mukta (Purified Pearl), is believed to help regulate thyroid function and reduce symptoms of hyperthyroidism due to its cooling and balancing properties. Clinical evidence on its efficacy remains limited, necessitating further research to validate its therapeutic benefits.
Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva.
Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais.
O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
Prof. Marcus Renato de Carvalho
www.agostodourado.com
- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
- Video recording of this lecture in Arabic language: https://youtu.be/Ve4P0COk9OI
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
Adv. biopharm. APPLICATION OF PHARMACOKINETICS : TARGETED DRUG DELIVERY SYSTEMSAkankshaAshtankar
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Basavarajeeyam is an important text for ayurvedic physician belonging to andhra pradehs. It is a popular compendium in various parts of our country as well as in andhra pradesh. The content of the text was presented in sanskrit and telugu language (Bilingual). One of the most famous book in ayurvedic pharmaceutics and therapeutics. This book contains 25 chapters called as prakaranas. Many rasaoushadis were explained, pioneer of dhatu druti, nadi pareeksha, mutra pareeksha etc. Belongs to the period of 15-16 century. New diseases like upadamsha, phiranga rogas are explained.
micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
2. Therapeutic Products Bill: Devices Session
Agenda for today:
1. Purpose & design of the Bill
2. Scope & Definitions
3. Product-related aspects
4. Activity-related aspects
5. Transition
6. Regulator powers & enforcement
3. Today’s team
• Sheila Swan – Chief Advisor, Regulatory Policy, MoH
• Hannah Adams – Senior Analyst, Regulatory Policy, MoH
• Susan Martindale – Principal Policy Analyst, Regulatory Policy, MoH
• Chris James – General Manager, Medsafe, MoH
• Pamela Randell – Project Coordinator, MoH
4. Purpose & Design of the Bill
Purpose:
The purpose of this Act is to protect personal and community health
by:
(a) ensuring acceptable safety, quality, and efficacy or performance
of therapeutic products across their lifecycle; and
(b) regulating the manufacture, import, promotion, supply, and
administration or use of therapeutic products.
Design
• Principles-based framework with three subordinate tiers.
5. Guiding principles of the Bill
The Regulator and any other person exercising a power under this
Act must be guided by the purpose of this Act and the following
principles:
(a) the likely benefits of therapeutic products should outweigh the
likely risks associated with them:
(b) regulation of therapeutic products should-
(i) be proportionate to the risks posed by the products; and
(ii) support the timely availability of therapeutic products:
(c) the administration of this Act should be carried on in an open
and transparent manner:
(d) there should be co-operation with overseas regulators,
compliance with international obligations, and, if appropriate,
alignment with international standards and practice.
6. There will be less detail in legislation and more in
the regulations and regulator-made instruments
Instrument Content Process
Therapeutic Products Act Primary legislation sets out:
• the purpose of the Act
• provides a set of principles and criteria to set the parameters
of the regulatory regime
• sets boundaries for the scope and development of
subordinate legislative instruments
• contains the primary elements of the regulatory regime
• provides enforcement powers
• sets out accountability arrangements
Legislative instrument, made by Parliament
Regulations Regulations will contain further detail on:
• matters not appropriately dealt with in regulator-made
instruments (such as fee setting)
• matters to do with accountability
• key elements of the regulatory regime that will remain
relatively stable and which are significant to the design of the
regulatory requirements
Schedule 3 lists the matters that can be specified in regulations
Legislative instrument, made by the Governor-General by
Order and Council
Regulations will be subject to review by the Regulations
Review Committee
Rules Contain the detail of the regulatory requirements
Schedule 3 lists the matters that can be specified in rules
Legislative instrument, made by the regulator
Subject to review by the Regulations Review Committee
Notices Contain administrative detail of the scheme
Schedule 3 lists the matters that can be specified in notices
Non-legislative instrument, made by the regulator
The regulator must not issue a notice unless satisfied that
doing so if necessary or desirable to promote the purposes
of the Act; and it is no broader than is reasonable necessary
to address matter that gave rise to it
7. Regulator Form
In providing advice to Cabinet on the Regulator Form, the Ministry
will be considering:
• Independence: decision-making and operations
• Accountability
• Sustaining capability and capacity
• Positive regulatory culture
• Efficiency and effectiveness (includes cost of establishment and
ongoing operations)
• Flexibility
8. What is a therapeutic product?
A product is a therapeutic product if-
(a) it is intended for use in, on, or in relation to humans for a
therapeutic purpose; or
(b) it is specified in the regulations to be a TP; or
(c) it is intended for use as an active ingredient of a medicine.
A naturally occurring thing …. may become a TP if it is changed from
its naturally occurring state…..
BUT…a product that would otherwise be a therapeutic product
under (a) is not a therapeutic product if it is a natural health
product.
[Section 16 (paraphrased)].
9. What does therapeutic purpose mean?
The following are therapeutic purposes:
(a) preventing, diagnosing, monitoring, alleviating, treating, curing, or compensating
for a disease, ailment, defect, or injury
(b) influencing, inhibiting, or modifying a human physiological process
(c) testing the susceptibility of humans to a disease or an ailment
(d) influencing, controlling, or preventing human conception
(e) testing for human pregnancy
(f) investigating, replacing, modifying, or supporting part of a human’s
anatomy
(g) supporting or sustaining human life
(h) disinfecting medical devices
(i) a purpose connected with a purpose referred to in paragraphs (a) to (h).
10. What does therapeutic purpose mean (contd)
Something is intended for use for a therapeutic purpose if it is, or
is in a
class of things that are-
(a) ordinarily used for that purpose; or
(b) intended by the responsible manufacturer to be used for that
purpose; or
(c) represented as being for use for that purpose; or
(d) likely (because of the way in which it is presented or for any
other reason)
to be used for that purpose.
11. The Bill would regulate 4 types of product
• Medicines
• Active ingredients of medicines (AMIs)
• Medical devices
• Type-4 products.
12. What is a medical device?
The distinguishing feature of a medical device is that it:
achieves, or is likely to achieve, its principal intended action by
means other than-
(A) pharmacological, immunological, or metabolic means; or
(B) the action of something that comprises, contains, or is derived
from human or animal cells or tissues
(although its function may be assisted by the means in A and B).
Regulator’s notices can also be used to declare something to be a
medicine, AMI, medical device or type-4 product.
13. Diversity of products and risk
The term medical device covers a wide range of products across a
wide risk spectrum, including:
• Surgical equipment
• Imaging and other diagnostic equipment
• Implants
• Dressings and catheters
• Software
• In-vitro diagnostic tests
• Hearing aids.
Question: Is better regulation needed for devices such as plano
contact lenses, dermal fillers used for “cosmetic” rather than
therapeutic purposes?
14. The new scheme would adopt the GHTF/IMDRF
global model for device regulation
• Devices must meet Essential Principles (relating to safety and
performance)
• Devices are allocated a Risk Classification using international
classification rules - this determines the level of regulatory
oversight and conformity assessment
• Conformity assessment procedures - the required procedures are
linked to the risk class for the device
• The manufacturer is responsible for maintaining a technical file
(STED) demonstrating conformity to the essential principles and for
completing a declaration of conformity
• Conformity assessments are undertaken by independent
Conformity Assessment Bodies (CABs) recognised by the regulator
(except for the lowest risk class of devices which can be self-
assessed by the manufacturer).
15. Rules & Notices will specify the detail
Rules would set product standards for medical devices that,
consistent with the global model, would specify:
• The 2 broad categories of device
• In-vitro diagnostic devices (IVDs)
• Devices that are not IVDs
• Essential Principles for each category of device
• Risk classifications for each category and the rules for determining
which risk class a device belongs in
• Conformity assessment procedures.
A Notice would list the Conformity Assessment bodies recognised
by the Regulator.
16. There would be more regulation of medical
devices across their lifecycle
Design, Develop & Test
Now: Not
regulated
Future:
•Clinical trials
would require a
licence
•Product
development data
would be required
as part of product
approval
Manufacture
Now: Not
regulated
Future:
•NZ
manufacturer
s would
require a
licence
•Overseas
manufacturer
s audited and
checked via
product
approval
process
Supply and use
Now: Suppliers
required to list
some medical
devices on the
Ministry’s
database within
30 days of market
entry
Future:
•Register of all
approved devices
would be required
•NZ wholesalers
would require a
licence (unless
exempt)
•Would be able to
apply use- and
supply-restrictions
Post-Market
Now:
•Voluntary
adverse event
reporting by
product sponsors
•Limited
enforcement
responses
Future:
•Mandatory
adverse event
reporting by
product sponsors
•Full suite of
enforcement
responses
Market Entry
Now: Not
regulated.
Some devices
required to
meet relevant
standards
specified in
other legislation
Future: Pre-
market product
approval would
be required
(with some
exceptions)
17. Product-related controls
Medical devices must not be imported or supplied unless the
product is:
• approved
• approval-exempt; or
• the person who is importing or supplying is authorised (via
the legislation, a licence or permit) to do so.
The importer must:
• be the sponsor for the product; or
• have the written consent of the sponsor; or
• be authorised to import without the sponsor’s consent.
18. The Bill would enable different product approval
pathways
The approval pathways would include:
• approval based on scrutiny of evidence of conformity assessment/
overseas approval of devices
• approval without scrutiny if devices are under a Mutual
Recognition Agreement (eg, those that fall under the EU MRA)
• self-declaration and notification for devices in the lowest risk class.
The NZ regulator would need to publish and maintain a list of
recognised conformity assessment bodies (in a Regulator’s Notice)
These will be a mix of third party conformity assessment bodies and
overseas regulators whose conformity assessments will be
recognised. The NZ regulator is unlikely to be doing conformity
assessments itself.
19. There would be “grouping” rules for products with
shared characteristics
• It would be possible for a single application to cover multiple
products provided they have specified characteristics in common.
We envisage the “grouping” rules would be similar to those in
Australia where:
o Lower risk devices can be grouped if they have the same
manufacturer, sponsor, risk classification, and GMDN code.
o High risk devices (class III, AIMD and most class 4 IVDs) must
have the same unique product identifier as well as the same
manufacturer, sponsor, risk classification, and GMDN code.
• The new scheme would also accommodate applications for kits and
procedure packs.
o
20. Criteria for product approval
The criteria for product approval are all of the following:
• the quality, safety, and efficacy or performance of the product for the purpose for
which it is to be used are satisfactorily established
• the likely benefits of the product outweigh the likely risks associated with it
• any other criteria for approval that are specified in the rules.
Product standards may relate to the product, its manufacture, its packaging and
labelling, its product or consumer information.
21. Evaluating an application for approval
The Regulator must evaluate the application having regard to:
• the criteria for product approval
• whether the product, if approved, will comply with the specified
product standards
• whether the person named in the application as the proposed
sponsor meets the criteria for a sponsor.
After evaluating the application, the Regulator must-
• grant approval or refuse to grant approval.
22. Approvals (contd)
Approvals can be:
• Subject to conditions - which can be specified in the Rules or
imposed by the Regulator at the time of approval or later.
Conditions can be added, varied or removed by the Regulator
• Granted with or without an end date
• Cancelled – for grounds see section 108.
23. Changes to approved products
Major changes to medical devices:
• Major changes will be listed in the Rules
• Approved product + major change = different product & new
approval
Minor changes to medical devices:
• There are 2 types:
o those that must be notified to the Regulator. These will be
listed in the Rules
o any other minor changes. These do not need to be notified or
approved
• The original approval covers all the minor changes.
24. Sponsors are important players
A sponsor:
• Is the person to whom a product approval is granted (or later
transferred); or
• For an approval-exempt product, is the person named (individually
or as a class of person) in the Regulator’s Notice declaring the
product (or class of product) to be approval-exempt.
25. Criteria for being the sponsor of an approved
product
(A) - Individual normally resident in NZ, or
- Body corporate incorporated in NZ; or
- The Crown
(B) The person imports or arranges the import of the product, or
manufactures it in NZ or arranges for its manufacture in NZ
(C) Are, or have a contractual relationship with, the responsible
manufacturer
(D) Agree to be the sponsor
(E) Are a fit and proper person
(F) Are, or will be, able to comply with the set of sponsor
obligations.
26. Sponsors have important obligations
The sponsor of an approved product is obligated to:
• Comply with the approval
• Ensure the product complies with its approval & any specified
product standards
• Ensure another person complies with any must do / must not
do requirements placed on that person by the approval
• Comply with any requirements in the regulations in relation
to:
o Product quality, safety, and efficacy or performance (includes ongoing
monitoring)
o Prescribing and consumer information, packaging & labelling
o Release for supply
o Market actions (eg tracing and recall), record keeping, auditing
o Giving information to the regulator (eg adverse event reporting).
27. Some activities require an authorisation
Manufacturing is a controlled activity requiring an authorisation
• A licence would be the usual way of authorising manufacture in NZ
• A person is a manufacturer if they do anything that is part of
manufacturing the product (s31(2))
• The responsible manufacturer is the one primarily responsible for the
manufacture of the product (s31(3)). Relevant considerations are:
o who initiated manufacture
o whose name would the device be supplied under
o who is responsible for overall QA and QC
• The licence would spell out the scope of what is permitted and could also
authorise those manufacturers who supply the responsible manufacturer
with components or sub-assemblies etc.
28. A person manufactures a device if they:
• Produce the device
• Do anything that is part of the process of producing the device or
bringing it to its final state (eg, testing, sterilising, releasing for
supply, packaging, labelling)
• Do anything that is part of remanufacturing the device.
However, preparing a device for use by following the
manufacturer’s instructions (eg, for assembly, calibration) is NOT
manufacture (s34(4)).
29. Remanufacture of a device
Remanufacture occurs if someone alters, refurbishes, further
processes a device so as to:
• Change its intended purpose or other major change
• Make it a different device
• Enable re-use of a device originally intended to be for single use
only
• Enable it to be used in a way that is very different from the way
the responsible manufacturer intended
Note that remanufacture does NOT mean:
• Cleaning the device
• Carrying out repairs & maintenance to enable the continued use
of the device in the originally intended manner
30. Supply by wholesale requires an authorisation
A person is supplying by wholesale if they have a reasonable belief that
the recipient is obtaining it in order to:
o Supply it to other people in the course of their business (as, for
example, a pharmacy would)
o To administer it to, or use on, patients in the course of their business
(as, for example, a DHB or health practitioner would)
o To use it in a scientific, educational or commercial laboratory
o To use it in a manufacturing or trade process
• A licence would be the usual way of authorising this controlled activity
• It would spell out the scope of what is permitted, including whether
unapproved devices may be supplied
• We envisage using regulations to “exempt” those who wholesale only
class I devices from needing a licence.
31. Conducting a clinical trial requires an authorisation
• A licence would be the usual way of authorising this controlled
activity
• It would spell out the scope of what is permitted & also authorise
the supply of the unapproved trial product.
32. Advertising controls
• Only approved products may be advertised
• Adverts must be consistent with the product approval & not
misleading
• Regulations would be used to specify more detailed
requirements.
33. Getting ready for the new scheme
Before the scheme can commence all of the following events must have occurred:
• The Bill must have received Royal Assent
• Regulations must be developed (following consultation), signed by the Governor-
General, published and in force
• Rules and Notices must be developed (following consultation), published and in
force.
The new Act, regulations, rules and notices would all come into force on the
same date (the commencement date for the scheme).
There is likely to be a gap of around two years between Royal Assent and
commencement. During this time, companies can start to get prepared for
commencement so they are ready to begin transitioning into the scheme.
The transition period begins on commencement date - so perhaps around late
2022 or early 2023.
The Bill gives temporary authorisations to those lawfully importing,
manufacturing and supplying devices before commencement to allow them to
continue those activities.
34. What needs to happen after commencement?
• Those wishing to introduce new products to the NZ market must first obtain a
product approval (unless the product is approval-exempt) or other authorisation for
the product
• Those wishing to start supplying by wholesale or start a clinical trial must first
obtain a licence (or other authorisation).
Those “existing players” who are covered by the temporary transition
authorisations need to apply for scheme approvals / licences within 6 months of
commencement.
As soon as they have done that, their temporary approval continues on until the
regulator determines their application.
35. The Regulator
• Must ensure it has a system to continuously monitor the safety of
lawfully supplied products
• May make public safety announcements (akin to current privileged
statements under the Medicines Act)
• May issue the following regulatory orders:
• Recall orders
• Premises restriction order
• Advertising remediation order
• Directions order
• Product prohibition order
• Medicines access limitation order.
2-tier Merits review mechanism is available.
36. Investigation powers
The Bill:
• Links to the Search & Surveillance Act 2012
• Has some additional powers tailored for this scheme (eg the
power to test samples)
• Enables the Regulator to conduct routine compliance checks and
enforcement activities
• Enables imported consignments to be detained, tested, destroyed
or removed from NZ.
37. Therapeutic Products Bill: Enforcement
The Bill has a modern hierarchy of enforcement tools:
• Tiered criminal offences with higher penalties
• Enforceable undertakings
• Infringement notices.
Officials are considering whether to add civil pecuniary penalties as
another regulatory option.
38. What next
• Sector forums in March
• Submissions due by 18 April
• Analysis of submissions & report back to Cabinet
• Draft Bill amended, as required
• Draft Bill introduced to Parliament
• Select Committee process (which usually includes a public submission process)
• Development of regulations, rules and notices – will involve consultation on detail
of the scheme.
Editor's Notes
The modern approach to drafting is to include much less detail in the legislation
This makes it much easier to keep the requirements of regulatory scheme up to date
But there are still lots of check and balances in place
A large proportion of the requirements would be set in regulations, which will be developed by the Ministry of Health, then require the approval of the Governor General
The regulator will be able to make rules and notices, but there are restrictions on what these can cover and requirements for when and how they can be made