REGULATORY BRAINBOX

Monthly Regulatory Newsletter April 2022

Medical Devices Regulatory Consultancy

Breaking Barriers for Complex Markets

Address: Planet House, North Heath Lane, Horsham, West Sussex RH12 5QE

Contact: 00447458300825 Email Id: info@omcmedical.co.uk

CONTENTS
AUSTRALIA ..................................................................................................................................................3
UNITED STATES OF AMERICA (USA) .................................................................................................3
EUROPEAN UNION (EU) ........................................................................................................................6
ITALY ..............................................................................................................................................................7
IRELAND........................................................................................................................................................7
MALTA ...........................................................................................................................................................8
POLAND........................................................................................................................................................8
UNITED KINGDOM (UK) ........................................................................................................................9
BRAZIL ...........................................................................................................................................................9
OMAN ........................................................................................................................................................ 10
SINGAPORE ............................................................................................................................................. 11
PAKISTAN ................................................................................................................................................. 13
SERVICES ................................................................................................................................................... 13
WHY CHOOSE US .................................................................................................................................. 14

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AUSTRALIA
Transitioning to the new Therapeutic Goods Advertising Code | 05 April 2022

The Therapeutic Goods Administration (TGA) is updating advertisers on the transitional arrangements for
the 2021 Advertising Code, particularly regarding hard copy ad stock.

On January 1, 2022, the Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021 (2021
Code) went into effect. The Therapeutic Goods Advertising Code (No. 2) 2018 is repealed and replaced by
the 2021 Code (2018 Code). Advertisers can comply with either the 2021 Code or the 2018 Code during the
transition period, which runs through June 30, 2022.

In comparison to the 2018 Code, the mandatory statement requirements in the 2021 Code have been
streamlined and decreased in number. However, the TGA recognises that advertisers may have hard copy
advertisements on hand that meet the 2018 Code's statutory statement requirements but are not strictly
compliant with the 2021 Code. While marketers use up their existing hard copy inventory, the TGA will
take a pragmatic approach and refrain from taking enforcement action when advertisers follow the 2018
Code's mandatory statement requirements rather than the 2021 Code's. The TGA expects marketers to
move to the 2021 Code requirements by the end of the transition period on 30 June 2022 for advertising
that can be easily altered.

UNITED STATES OF AMERICA (USA)

Counterfeit At-Home OTC COVID-19 Diagnostic Tests | 29 April 2022

Counterfeit COVID-19 tests are tests that have not been authorised, cleared, or approved by the FDA for
distribution or use in the United States but are designed to appear like authorised tests so that consumers
believe they are actual FDA-approved tests. The FDA is worried about the possibility of erroneous findings
when consumers use these illegal tests since the performance of these bogus tests has not been thoroughly
proven. The FDA has a list of authorized at-home OTC COVID-19 diagnostic tests.

Resilient Supply Chain Program for Medical Devices| 20 April 2022

The Resilient Supply Chain Program (RSCP) for medical devices aims to strengthen public health supply
chains by proactively monitoring, assessing, and communicating risks and vulnerabilities to minimise
medical device shortages.

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The RSCP was created to improve the FDA's ability to prevent and mitigate supply chain disruptions and
promote resiliency in the US medical device supply chain to ensure that patients have access to safe and
effective medical devices by:

• Developing strategies, analyses, and informational products to prevent and, when appropriate,
mitigate medical device supply chain disruptions and shortages
• Identifying supply chain hazards and disseminating actionable information to medical device
manufacturers, distributors, healthcare delivery organisations, patients, healthcare employees, and
government partners. Developing communication channels across the medical device ecosystem to
enhance collaborations for the development of prevention and risk reduction strategies
• Enhancing collaborations for the development of prevention and risk reduction strategies by
developing communication channels across the medical device ecosystem
• Working with government partners and medical device stakeholders to evaluate supply chain
disruption and shortage signals, assess potential consequences, and provide public health data to
assist an informed response.

Genetic Non-Invasive Prenatal Screening Tests May Have False Results: FDA Safety
Communication | 19 April 2022

The Food and Drug Administration (FDA) in the United States is alerting consumers and healthcare
providers about the dangers of misleading results from genetic non-invasive prenatal screening (NIPS)
tests, also known as non-invasive prenatal testing or tests (NIPT). NIPS tests can reveal whether a foetus
has specific genetic abnormalities that could lead to a child being born with a severe health problem.

The FDA is providing this information to educate patients and health care providers and assist limit the
improper use of NIPS testing due to the increased usage of these tests and concerns raised in recent media
stories. Before electing to receive NIPS tests, the FDA suggests that patients talk to a genetic counsellor or
other health care provider about the benefits and dangers. Before making any decisions concerning their
pregnancy, patients should review the results of NIPS tests with a genetic counsellor or other health care
practitioner. These screening tests have dangers and limits, and the results should not be used to identify
chromosomal (congenital) abnormalities or illnesses on their own.

Breakthrough Devices Program | 15 April 2022

The Breakthrough Devices Program is a voluntary programme that recognises specific medical devices and
device-led combination solutions that improve the treatment or diagnosis of life-threatening or irreversibly
debilitating diseases or conditions.

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The FDA's Breakthrough Devices Program allows manufacturers to interact with FDA experts through
various programme options, allowing them to address issues that arise during the premarket review phase
quickly. This programme can help manufacturers receive feedback from the FDA and identify areas of
agreement. Manufacturers might also expect their submission to be reviewed first.

Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket

Submissions | 07 April 2022

FDA Released draft guidance that applies to devices that incorporate software (including firmware) or
programmable circuitry, as well as software as a medical device (SaMD). The guidance is not restricted to
network-enabled devices or have other linked features. The guidance offers suggestions for cybersecurity
information to be supplied for devices under the following premarket submission categories:

• Premarket Notification (510(k)) submissions

• De Novo requests
• Premarket Approval Applications (PMAs) and PMA supplements
• Product Development Protocols (PDPs)
• Investigational Device Exemption (IDE) submissions
• Humanitarian Device Exemption (HDE) submissions

The document can be found here.

Medical Device Interoperability | 05 April 2022

Medical device interoperability refers to the capacity to share and use data between one or more devices,
products, technologies, or systems in a safe, secure, and efficient manner. This data can be displayed, stored,
interpreted, analysed, and utilised to automatically act on or control another product, among other things.

As electronic medical devices grow more connected to one another and other technologies, the capacity of
interconnected systems to share and use data safely, securely, and effectively becomes increasingly
essential.

Interoperable devices that can communicate data across systems and platforms can help to improve patient
care, reduce errors and adverse events, promote innovation, and enable more diversified study datasets.

The FDA encourages intelligent, secure, and safe interoperability between medical devices and information
systems. To promote medical device interoperability, the agency has worked with hospitals, health care
providers, manufacturers, standards development organisations, and other interested parties.

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EUROPEAN UNION (EU)
Guidance on borderline between medical devices and medicinal products under Regulation (EU)
2017/745 on medical devices | 26 April 2022

The difference between Regulation (EU) 2017/745 on medical devices (MDR) and Directive 2001/83/EC on
medicinal goods for human use (MPD) is critical for the appropriate implementation, interpretation, and
enforcement of the two sets of laws.

Several sections in the MDR and MPD serve as a separating line between the two legal frameworks. This
guidance document includes further clarifications and examples of essential regulations to aid in the
uniform implementation of the MDR across the EU. A working group of experts from Member States'
relevant agencies, Commission services, the European Medicines Agency, and various stakeholders
prepared the document.

Clinical Trials Regulation Question and Answer document | 13 April 2022

European Commission has released a question-and-answer document on Clinical Trials Regulation (EU)
536/2014. The goal of the paper is to provide answers to clinical trial-related issues. This article contains
commonly requested 'questions and answers about how the rules on clinical trials are implemented. All
revisions to these questions and answers are given and debated by the "Expert group on clinical trials" and
reflect the group's viewpoint. The document can be accessed here.

EUDAMED - UDI/Devices technical documentation update | 11 April 2022

Regulations (EU) 2017/745 and 2017/746 introduced the EU device identification system based on a unique
device identifier (UDI), allowing medical devices traceability. This requires that manufacturers submit the
UDI/Device information of all devices they place on the EU market in EUDAMED. The document clarifies
the data provided in EUDAMED for the UDI module.

EUDAMED - NBs & Certificates module technical documentation update | 11 April 2022

Notified Bodies (NB) should register in EUDAMED any information regarding certificates issued (including
amendments and supplements), suspended, reinstated, withdrawn, or refused and other restrictions

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imposed on these certificates. Such information is accessible to the public. The document clarifies the
update in the EUDAMED NB & certificates module.

Joint implementation and preparedness plan for Regulation (EU) 2017/746 on in vitro
diagnostic medical devices (IVDR) | 01 April 2022

The IVDR (In-Vitro Diagnostic Medical Devices Regulations) is set to effect on 26 May 2022. The Medical
Device Coordination Group (MDCG), which comprises experts appointed by the Member States, approved
a Joint Implementation Plan for the MDR in March 2020. Priority activities for Member States and
Commission services were outlined in the plan, which would be monitored at the MDCG level. The MDR
joint implementation plan acknowledged a similar process for the IVDR. As a result, the present document
proposes a draft IVDR joint implementation plan. The document was updated this month.

ITALY
Report on surveillance activities 2020 | 08 April 2022

The report outlines the medical device and in vitro diagnostic medical device monitoring operations carried
out during 2020. The report analyses the data collected in the Ministry's supervisory system database based
on health professionals' and manufacturers' recommendations. The publication is aimed at all stakeholders
in the device sector, including manufacturers, healthcare professionals, patient associations, and central
and local institutions interested in purchasing and managing medical devices and in vitro medical-
diagnostic devices. It allows the reader to acquire helpful information elements to carry out better their
professional activity in medical devices and in vitro medical-diagnostic devices that have already been
placed on the market. The Italian report can be found here.

IRELAND
Webinar - In-Vitro Diagnostic Medical Devices Regulation | 21 April 2022

The HPRA (Health Products Regulatory Authority) will host a free webinar on the In-Vitro Diagnostic
Medical Devices Regulation (IVDR), which will address significant subjects and provide practical
information on the IVDR's implementation, regulatory implementation at the national and European

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levels, post-market surveillance, vigilance and registration requirements, and HPRA inspections and
performance studies. For registration, visit here.

Annual Communication | 21 April 2022

If the synthetic methods, processing equipment, cleaning or containment procedures are comparable to
active substances, HPRA has published a form for the manufacturer, importer, or distributor of active
substances to add new active substances to the registration.

Medical Device Regulation: Survey for healthcare professionals | 25 April 2022

The Health Products Regulatory Authority (HPRA) is surveying to assess healthcare professionals'
awareness and understanding of medical device (MD) and in vitro diagnostic medical device (IVD) laws in
Ireland. This survey's results will only be used to identify particular regulatory subjects of concern to
healthcare professionals and determine how to effectively help them with medical devices and IVD
regulations. The survey can be found here, and the deadline to submit it is 13 May 2022.

MALTA
Self-Test COVID-19 Kits | 15 April 2022

The Malta Medicines Authority has released applications inviting distributors to submit applications to
make Covid-19 Self-Test Kits available to the public.

POLAND
Introduction of robotic surgery to the public health system | 08 April 2022

Health Minister Adam Niedzielski launched the introduction of robotic surgery into Poland's public
healthcare system.  The financing of robotic surgery procedures is a technological leap in Polish healthcare;
all operations will be reimbursed according to a specially calculated tariff, said Adam Niedzielski at the
Provincial Specialist Hospital in Wrocław during a conference on the development and financing of robotics

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inpatient treatment. - On the one hand, robots make doctors' jobs simpler, and on the other hand, it ensures
that patients receive the best possible care' he added further.

UNITED KINGDOM (UK)

Written Confirmations for export to EEA and Northern Ireland of Active Substances
manufactured in Great Britain | 04 April 2022

The United Kingdom is designated as a Third Country to export Active Substances for Human Use to the
European Economic Area (EEA). Northern Ireland's active substance manufacturers will continue to be
accepted by the European Economic Area. Each shipment of Active Substance manufactured in the UK
exported to the EEA, and Northern Ireland will then require a Written Confirmation. For the Written
Confirmation, a template has been created here. This Written Confirmation certifies the following for a
third nation exporting Active Substances to the EEA:

• the standards of Good Manufacturing Practice (GMP) are equivalent to those in the EU/EEA
• the manufacturing plant is subject to regular inspections (which may be both announced and
unannounced)
• significant non-compliance events would be communicated to the EEA without delay

BRAZIL
Import of goods and products under sanitary surveillance | 20 April 2022

ANVISA issued a Notice inviting any individual or institution interested in the topic to provide data and
information to identify difficulties encountered in the import procedures of goods and products subject to
sanitary monitoring. The implementation of laws for international trade activities should consider the
promotion of product access and the reduction of the health risk of these items to the Brazilian population.
Any person or organisation interested in the issue is welcome to participate in the consultation, particularly
those involved in foreign commerce, such as importers, exporters, customs brokers, carriers, customs, and
representatives from other federal agencies. Those interested in taking part must complete the survey
between 26 April 2022 and 09 June 2022.

ANVISA discloses data on adverse events | 07 April 2022

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The 1st Newsletter on Post-Market Monitoring of products and services subject to health surveillance has
been released by ANVISA. Based on data from the System of Notification and Investigation in Sanitary
Surveillance, the publication includes information on notifications of adverse events, technical complaints,
product quality deviations, and reports of intoxications. The data covers poisoning, Surveillance and
Control Measures, Cannabidiol, Kit Intubation, Sanitizing, and Cosmetovigilance.

Implantable defibrillators and cardiac valve prostheses | 01 April 2022

ANVISA issued Call Notices 5 and 6 in the Official Gazette (D.O.U.) requesting holders of registrations for
implanted defibrillators and cardiac valve prosthesis, which follow the technical qualities specified in
Normative Instruction (IN) 119/2022 and having the following technical names:

• Implantable double chamber defibrillator

• Single-chamber implantable defibrillator
• Implantable defibrillator for cardiac resynchronization therapy
• Biological cardiac valve prosthesis
• Mechanical cardiac valve prosthesis

to send technical attributes of each model of medical device (health product) registered with ANVISA for
economic monitoring purposes in a spreadsheet. The technical attribute data collected will be used to create
economic monitoring panels for implantable defibrillators and cardiac valve prostheses, which will enable
the grouping of products with similar technical specifications and the disclosure of price history statistics
used in public purchases, reducing asymmetric information in the market.

OMAN
MOH Gains ISO International Recognition | 13 April 2022

The Ministry of Health, represented by the Directorate General of Quality Assurance Center (DGQAC),
was awarded ISO 9001/ 2015 certification by the International Organization for Standardization in 2020
for the following directorates:

• The Directorate General of Administrative Affairs

• The Directorate General of Financial Affairs
• The Directorate General of Pharmaceutical Affairs & Drug Control
• The Directorate General of Private Health Institutions
• The Directorate General of Projects & Engineering Affairs

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SINGAPORE
Guidance on Change Notification for Registered Medical Devices | April 2022

This guideline document aims to assist registrants in assessing whether a Change Notification for a medical
device listed on the Singapore Medical Device Register (SMDR) is required. Registrants must inform the
Authority about the modifications of the registered medical devices under the Health Products (Medical
Devices) Regulations 2010 (Regulations). As a consequence of a reportable Adverse Event (AE) or an
ongoing Field Safety Corrective Action, this guidance also applies to circumstances where a registered
device undergoes any adjustments or planned changes, including labelling changes (FSCA). The guidance
document can be accessed here.

Software Medical Devices – A Life Cycle Approach | April 2022

This guideline is produced by the Health Sciences Authority (HSA) to clarify the regulatory obligations for
software medical devices across their entire life cycle, from product development through post-market
activities following their launch in Singapore. This guideline is only a recommendation. It should not be
interpreted as a new regulatory control on software medical devices by anyone involved in developing and
providing such devices in Singapore. This paper addresses essential software-related regulatory
requirements, such as cybersecurity and regulations for Artificial Intelligence (AI) medical devices, and it
applies to the software of all Risk Classifications. With new software-related technologies and growing
hazards, these rules will be evaluated and updated regularly. The document can be found here.

Risk Classification of Standalone Medical Mobile Applications and Qualification of Clinical

Decision Support Software (CDSS) | April 2022

To establish the risk categorization of Standalone Medical Mobile Applications that are Medical Devices,
this guideline refers to the IMDRF's Framework for Software as a Medical Device (SaMD) (commonly
referred to as SaMD). This guideline further clarifies whether Clinical Decision Support Software (CDSS)
is classified as a regulated medical device or not and the current regulatory approach and standards for
such software regulated by HSA. The guideline can be found here.

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HSA’s advisory on factors that may affect the accuracy of COVID-19 antigen rapid self-test kit
results | 04 April 2022

COVID-19 testing, including polymerase chain reaction (PCR) testing and antigen rapid tests (ART), are
helpful tools for detecting COVID-19 infection. While professional PCR tests and ARTs performed by
healthcare professionals are assumed to have greater precision, self-testing remains an essential tool in
public health response during a pandemic because it is easily accessible, inexpensive, and provides faster
results in the detection of COVID-19. The Health Sciences Authority (HSA) has evaluated all COVID-19
ART self-test kits to fulfil the required safety, performance, and quality requirements. However, the test
findings may be influenced by a variety of circumstances, including the viral load of the individual and
the sampling method used. Companies must notify HSA of any erroneous findings from their ARTs that
they are aware of, and HSA must investigate to rule out any quality or performance concerns with their
tests. HSA is actively watching local and worldwide trends and will take appropriate measures if
necessary.

Guidance - Special Access Routes (SAR) | 01 April 2022

All Class B, C, and D medical devices must be registered with the Health Products Act (Act) and the Health
Products (Medical Devices) Regulations 2010 (Regulations) before being sold in Singapore. Qualified
practitioners (i.e., physicians and dentists) sometimes need access to unregistered medical devices to fulfil
exceptional clinical needs emerging in their profession in an emergency or when all conventional treatments
have failed. Qualified practitioners may use unique access methods to access unregistered medical devices
for use on their patients. More details can be found here.

Note: The Special Access Routes (SAR) updates for unregistered medical devices will take effect from 1
April 2022.

Webinar - Dental Laboratory Regulatory Requirements in Singapore | 01 April 2022

The Singapore Health Sciences Authority will have a Zoom webinar to discuss the regulatory standards for
dental laboratories that manufacture or modify dental devices. The regulatory obligations that apply to
dental laboratories that manufacture devices for local use and guidance on the notification and reporting
processes will be covered in this webinar. For more details and registration, visit.

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PAKISTAN
DRAP issues final Guidance document for applicants on Import and Export permissions of
therapeutic goods in the country | 27 April 2022

DRAP has regulatory control over the import and export of all therapeutic products to evaluate if they are
permissible under relevant drug laws and prohibits entrance or exit of any therapeutic commodity if the
regulatory standards are not met. These regulatory measures are in place to prevent substandard
therapeutic products from entering the market and to ensure that standard quality therapeutic goods are
available. These regulatory controls are in place to keep inferior products out of the supply chain and ensure
that standard quality therapeutic commodities are available. The document can be accessed here.

SERVICES
OMC Medical offers regulatory support in the following domains:
CE Marking
MDD to MDR transition
Europe EU Authorized Representative
EUDAMED registration
Clinical Evaluation Process in EU
Local country listing: Italy (NSIS), France (ANSM), Germany (BfArM), Portugal
(Infarmed)
Switzerland Swiss Authorized Representative
MedDO Compliance
UK Responsible Person & MHRA registration
UKCA Marking
United Free Sale certificate
Kingdom Legalization Notarization
Cosmetic Products Representation, Notification

Eastern Europe Russia | Kazakhstan | Serbia | Ukraine| Uzbekistan | Armenia| Belarus

Africa Kenya | South Africa | Nigeria | Azania

Middle East Authorized Representative

Saudi Arabia | Bahrain | UAE | Oman

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 Asia Pakistan |Singapore |Japan

510(k)
USA Q– Submission process
De– Novo Submission

Turkey Medical Device Registration

Cosmetics Registration
Pharmaceutical Registration

Malaysia Authorized Representative

Registration of Medical Devices with the MoH (Kementerian Kesihatan)

India Authorized Representative

Registration of Medical Devices with CDSCO
Import permit certification
Clinical Evaluation, Biocompatibility testing
Document Translation
As per EU MDR, Instruction for use and labelling needs to be translated into up to 24 languages depending
on the country language in the EU where the product is marketed.
The deadline is approaching soon, and we can help you with swift, cost-effective translation solutions.
We comply with ISO 13485 standards, and we can ensure that the quality is not compromised.
Regulatory Staffing
Canada Regulatory Submission

WHY CHOOSE US
❖ Transparent and works with clients’ budget requirements.
❖ One stop consultancy for all Medical Device / Cosmetic requirements.
❖ ISO certified consultancy and Translation Agency.
❖ Timely service.
❖ Flexible and Friendly team.
❖ Global know-how.
❖ Not a consultant but a “true partner”.

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