May 19, 2021 Regulatory Updates
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Medical Devices – Regulatory Updates- May Volume 2

EUROPE

1. MDCG 2021-1 – Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional

Article 123(3)(d) MDR addresses the possibility that EUDAMED is not fully functional on the date of application of the MDR (26 May2021). Accordingly, the obligations and requirements in the MDR that relate to EUDAMED shall apply from the date corresponding to six months after the date of publication of the notice referred to in Article 34(3) – notice of full functionality of Eudamed. Until EUDAMED is fully functional, the MDR stipulates that the corresponding provisions of Directives 90/385/EEC4and 93/42/EEC5shallcontinue to apply for the purpose of meeting the obligations laid down in the provisions of Article 123(3)(d) regarding the exchange of information.

In addition, Article 123(3)(e) MDR clarifies that Article 29(4) MDR on the registration of devices, and Article 56(5) MDR on the registration of certificates, start to apply 24 months after the date of publication of the notice referred to in Article 34(3) MDR.

Article 122 is outside scope of this guidance.

The proposed practices and solutions set out in this document do not affect the general obligations of the parties to comply with the requirements under the MDR, including those contained in the provisions referred to in Article 123(3) letters (d) and (e) MDR.

Whenever this guidance makes reference to CircaBC6as alternative solution, the Commission and other relevant parties should endeavor to make use of already existing Circa BC directories to the extent that this is possible and appropriate.

Parties should also take note of the MDCG Position Paper on the use of the EUDAMED actor registration module and of the Single Registration Number (SRN) in the Member States.

https://ec.europa.eu/health/sites/default/files/md_sector/docs/2021-1_guidance-administrative-practices_en.pdf

US FDA

2. FDA continues to Monitor the Effects of Magnets in Consumer Electronics on Implanted Medical Devices

As part of consumer protection mission, the agency reviewed recently published articles describing the possibility that certain newer cell phones, smart watches and other consumer electronics with high field strength magnets may temporarily affect the normal operation of implanted electronic medical devices, such as pacemakers and implantable defibrillators. Based on our review, we decided to conduct our own testing to confirm and help inform appropriate recommendations for patients and consumers.

As a result of these actions, FDA is taking steps to provide information for patients and health care providers to ensure they are aware of potential risks and can take simple proactive and preventative measures. FDA believes the risk to patients is low and the agency is not aware of any adverse events associated with this issue at this time. However, the number of consumer electronics with strong magnets is expected to increase over time. Therefore, FDA recommends people with implanted medical devices talk with their health care provider to ensure they understand this potential risk and the proper techniques for safe use.

The FDA will continue to monitor the effects of consumer electronics on the safe operation of implanted medical devices.”

https://www.fda.gov/news-events/press-announcements/fda-brief-fda-continues-monitor-effects-magnets-consumer-electronics-implanted-medical-devices

3. Magnets in Cell Phones and Smart Watches May affect Pacemakers and other Implanted Medical Devices

The FDA recommends patients keep any consumer electronic devices that may create magnetic interference, including cell phones and smart watches, at least six inches away from implanted medical devices, in particular cardiac defibrillators. Many implanted medical devices have FDA-approved information written for patients (patient labeling), which cautions patients to keep all cell phones and smart watches at least six inches from the implanted medical device.

People with implanted medical devices may want to take some simple precautions, including:

  • Keep the consumer electronics, such as certain cell phones and smart watches, six inches away from implanted medical devices.
  • Do not carry consumer electronics in a pocket over the medical device.
  • Check your device using your home monitoring system, if you have one.
  • Talk to your health care provider if you are experiencing any symptoms or have questions regarding magnets in consumer electronics and implanted medical devices.

When near high strength magnets, devices with a magnetic safe mode could stop working or change how the device works. For example, a cardiac defibrillator may be unable to detect tachycardia events. Or it may change the operational mode of the devices such as turning on asynchronous (i.e., two or more events not happening at the same time) mode in a pacemaker.

Cardiac implanted electronic devices are intended to support heart rhythm disorders, such as slow or fast heart rates. When the device stops working, a patient may experience dizziness, loss of consciousness or even death if therapy is not delivered when life saving shocks are required.

It is important to emphasize the following: to avoid interference between cell phones and smart watches and your heart device, keep them at least six inches (15 centimeters) away from implanted medical devices. Also, do not place cell phones, smart watches, and other consumer electronics close to your implanted medical device.

The FDA is aware of published articles which describe the effect that sufficiently strong magnetic fields can turn on the magnetic safe mode when in close contact. The FDA also conducted its own testing on some products that use the high field strength magnet feature and have confirmed the magnetic field is both consistent with the publications and strong enough to turn on the magnetic safety mode of the medical devices in question. The FDA believes the risk to patients is low, and the agency is not aware of any adverse events associated with this issue at this time.

https://www.fda.gov/radiation-emitting-products/cell-phones/magnets-cell-phones-and-smart-watches-may-affect-pacemakers-and-other-implanted-medical-devices#:~:text=The%20FDA%20recommends%20patients%20keep,devices%2C%20in%20particular%20cardiac%20defibrillators.&text=Do%20not%20carry%20consumer%20electronics%20in%20a%20pocket%20over%20the%20medical%20device

CANADA (HEALTH CANADA)

4. Notice: Applications for COVID-19 drug and medical device clinical trials under the interim order (IO) 2: Notice of updated guidance documents

The guidance documents apply to COVID-19 clinical trials for pharmaceutical and biologic drugs (including blood and blood components) and medical devices, including combination products. The documents also apply to applicants and authorization holders of COVID-19 drug and medical device clinical trials under IO No. 1.

Not included in the IO are radio pharmaceuticals (see schedule C of the Food and Drugs Act), natural health products and Class I medical devices. Please refer to the device guidance for additional information on eligible and non-eligible studies.

The existing regulations and guidance for all non-COVID-19-related clinical trials and those that are not in scope of the IO continue to apply to those trials.

Implementation: The guidance documents will be in effect for a period of 1 year from the date the Minister signed IO No. 2.

Applicants of COVID-19 drug and medical device clinical trials can apply for authorization under either:

  • IO No. 2
  • Part C, Division 5 of the Food and Drug Regulations or
  • Part 3 of the Medical Devices Regulations

Once applicants apply for authorization under IO No. 2, they must proceed with that pathway.

Trials not authorized under IO No. 1 and that have already started cannot be transitioned under IO No. 2. These trials must follow the requirements of the regulations under which they were originally submitted.

Interim order implications for applicants

IO No. 2 continues to facilitate the launch of COVID-19-related clinical trials. It reduces the administrative burden related to authorization and implementation without compromising the health and safety of participants and validity of trial data.

As IO No. 2 covers both drugs and medical devices, it uses the common term “clinical trial” rather than the Medical Devices Regulations term “investigational testing”.

An IO authorization covers:

  • the sale or importation of a drug or a medical device for the purpose of the clinical trial
  • the conduct of the trial

This better enables flexible oversight through all stages of a trial.

The IO continues to reduce the administrative requirements for non-significant changes throughout the trial, with only significant changes requiring approval.

It also:

  • provides other ways to obtain informed consent
  • expands the range of applicants who are able to apply for a medical device clinical trial authorization
  • permits the use of a broader range of qualified investigators for drug clinical trials (broad range of qualified investigators is maintained for medical device trials)
  • reduces administrative requirements for trials involving new uses for existing marketed drugs

All these flexibilities will be particularly beneficial for complex trials, such as:

  • multi-site trials
  • multi-arm trials
  • remote trials
  • trials for repurposing marketed drugs or medical devices for COVID-19 uses

All other requirements for applicants continue to apply. These include requirements for the submission of applications and reporting of trial-related adverse events or medical device incidents to Health Canada. Applicants will also be obligated to ensure their drug clinical trial is conducted in accordance with good clinical practices.

This also means that any applications that were outstanding when IO No. 1 was repealed would be considered as applications under IO No. 2.

https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/interim-order-2-clinical-trials-medical-devices-drugs/guidance-documents-notice.html

5. Interim Order No. 2 respecting clinical trials for medical devices and drugs relating to COVID-19

Why a new interim order was issued

Health Canada has authorized a few therapies and vaccines to treat or prevent COVID-19. However, there continues to be a need to study and investigate therapeutic products through clinical trials to protect the health and safety of Canadians and meet an urgent public health need. Clinical trials are an important step in finding safe and effective treatment options for patients.

IO No. 1 is also set to expire on May 23, 2021. (Interim orders have a maximum duration of 1 year from the date they are made.)

IO No. 2 maintains the optional pathway introduced under IO No. 1 for any new COVID-19 drug and device clinical trials.

What’s new in IO No. 2

New transitional provisions will address:

  • any clinical trial submissions that are outstanding when IO No. 1 expires or
  • authorizations for drugs and devices issued under IO No. 1

This is to ensure there’s no interruption in the authorizations, obligations and oversight made possible by IO No. 1.

This means that:

  • all applications, authorizations, suspensions, revocations and requests made under IO No. 1 are deemed to be made under IO No. 2
  • all requirements and obligations imposed under IO No. 1 are deemed to be requirements and obligations under IO No. 2
  • requests by the Minister for information or materials under IO No. 1 are deemed to be requests under IO No. 2

Minor technical fixes have also been made to:

  • address the French and English discrepancies in subsections 15(2) and 15(3) of IO No. 1 and
  • clarify provision 28(h) of IO No. 1 on informed consent

Facilitating COVID-19 clinical trials in Canada

IO No. 2 continues to offer regulatory flexibility to allow for broader types of COVID-19 clinical trials to take place more efficiently. This flexibility also facilitates broader patient participation across the country.

IO No. 2 will help to:

  • reduce administrative requirements for assessing the use of existing marketed drugs as possible COVID-19-related therapies
  • allow alternate means of obtaining patient consent in light of COVID-19 realities
  • broaden the criteria for qualified health professionals who can carry out qualified investigator duties at remote sites for drug clinical trials
  • expand the range of applicants who are able to apply for a medical device clinical trial authorization

Prioritizing COVID-19 clinical trials

Under IO No. 2, Health Canada will continue to review clinical trials applications (and amendments) for COVID-19-related drugs and medical devices within 14 days. Research ethics boards across the country are also prioritizing reviews and approvals for COVID-19 clinical trials.

The IO No. 2 pathway is an alternate pathway to the existing regulatory pathways in the Food and Drug Regulations and Medical Devices Regulations. As an alternative to these requirements, the applicants of clinical trials for COVID-19-related drugs and medical devices may choose to use this pathway.

https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/interim-order-2-clinical-trials-medical-devices-drugs/notice.html

6. Priority COVID-19 test applications: Notice to manufacturers, importers and distributors

The purpose of this notice is to communicate the types of testing technologies that Health Canada considers are a priority for review.

Only commercial testing devices that we have authorized can be advertised, imported or sold in Canada. Unauthorized tests may not produce accurate results, leading to potential misdiagnosis. Authorized COVID-19 tests are well supported by evidence that shows they will provide accurate and reliable results.

Technologies that are a priority

Working with our public health partners, we have identified the following testing technologies as being of the highest priority for evaluation at this time:

  • self-testing devices
  • point-of-care antigen or molecular testing devices that use nasal swab or saliva samples for use in symptomatic and asymptomatic populations administered by trained operators (rather than health care professionals)
  • asymptomatic populations are people who do not display COVID-19 symptoms at the time of testing (see the guide on COVID-19 signs, symptoms and severity of disease)
  • to add to clinical trial populations, asymptomatic people may include those who have recently had contact with someone diagnosed with COVID-19 (applicants are encouraged to contact us before designing a clinical trial to ensure appropriate populations are included and adequately characterized)

We welcome new applications for these types of tests, as well as applications to amend authorized tests to include these new features.

Applicants should provide direct evidence or scientific justification if appropriate. Scientific justification could include scientific articles on the performance of an applicant’s device or highly similar device by trained operators, or in sample asymptomatic populations.

Applicants are invited to consider strategies to strengthen the performance of their device for its claimed indications. Strategies may include:

  • serial testing strategies
  • paired testing strategies
  • clarification of how the intended purpose of the testing device meets specific public health goals

These strategies could likewise be supported by direct evidence or scientific justification, if appropriate.

Other technologies that are a priority include:

  • point-of-care antigen tests that do not use only nasopharyngeal (NP) swab samples, or may be used in asymptomatic people or may be administered by trained operators
  • point-of-care molecular tests that do not use only NP swab samples, or may be used in asymptomatic people or may be administered by trained operators
  • tests designed to address emerging variants
  • tests that offer new or unique advantages compared to other tests of the same type
  • novel diagnostic technologies that may use alternative samples, such as breath, or a different analytical approach

https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/medical-devices/testing/priority-test-applications-notice.html

AUSTRALIA (TGA)

7. Medical devices reforms: Reclassification of certain medical devices

The Therapeutic Goods Legislation Amendment (2019 Measures No.1) Regulations 2019(link is external) were made on 12 December 2019, which amends the Therapeutic Goods (Medical Devices) Regulations 2002 to reclassify six categories of medical devices:

  • spinal implantable medical devices
  • active medical devices for therapy with diagnostic function
  • active implantable medical devices and their accessories
  • medical devices that administer medicines or biologicals by inhalation
  • medical devices that consist of substances introduced into the body via a body orifice or applied to the skin

The TGA will continue to consult regarding the proposed medical device classification for storage solutions for human cells, tissues and organs, and IVF media in order to clarify issues raised in submissions, prior to considering regulatory amendments for this category of devices.

For more information on what changes are being made see:

  • Outcomes of reclassification of a number of medical devices following consultations in 2019.
  • Reclassification of surgical mesh medical devices

Guidance is in development to include further information about the reclassifications and transitional arrangements for devices that are currently included in the ARTG.

Five draft guidance documents were provided to the Regulatory and Technical Consultative Forum for medical devices in June 2020 for feedback to inform the final guidance documents.

Further information and guidance about the new classification rules and transitional arrangements will be published as it becomes available.

  • Reclassification of active medical devices for therapy with a diagnostic function
  • Reclassification of active implantable medical devices (AIMD)
  • Reclassification of medical devices that administer medicines or biologicals by inhalation

https://www.tga.gov.au/medical-devices-reforms-reclassification-certain-medical-devices

JAPAN (PMDA)

8. SaMD Centralized Consultation Service (Medical Device Program Comprehensive Consultation)

On November 24, 2nd year of Reiwa, the Ministry of Health, Labor and Welfare announced “DASH for SaMD”.

Based on this, in order to promote the early commercialization of cutting-edge program medical devices (SaMD: Software as a Medical Device), the consultation on SaMD conducted by the Ministry of Health, Labor and Welfare and PMDA is called “Medical Device Program Comprehensive Consultation”. PMDA have set up a centralized reception desk (consigned by the Ministry of Health, Labor and Welfare).

Consultation is free.

In principle, consultation regarding (1) applicability is by email; consultations on (2) regulatory development and (3) medical insurance will be conducted at a web conference.

The main advantages of Regulatory development consultation are that (1) applicability and (3) medical insurance consultation can be carried out with a single application.

If you have already confirmed the applicability to medical devices and have received general consultations, it would be a good idea to continue using individual consultations. If the purpose of use or specifications change during development and you need to check the applicability again, or if you want to use medical insurance consultation, please consider using the SaMD centralized consultation desk.

https://www.pmda.go.jp/review-services/f2f-pre/strategies/0011.html

9. About digitization of package inserts

Digitization of package inserts

Due to the revision of the Act on Securing Quality, Effectiveness, and Safety of Pharmaceuticals and Medical Devices (hereinafter referred to as the “Pharmaceutical Machinery Act”), it has been the same as products such as pharmaceuticals since August 2021. As a general rule, the enclosed paper package inserts will be abolished *, and it will be basically viewed electronically. This page introduces how the package insert will be viewed in the future, its detailed mechanism, and system specifications. The information provided is current and will be updated in the future.

* For products purchased directly by consumers, such as over-the-counter drugs, paper package inserts will continue to be included.

How to view the package insert after digitizing the package insert

After August 2021 when the revised Pharmaceutical Machinery Law comes into effect, the barcode or two-dimensional code attached to the box containing medicines, etc. will be read using an application on a smart phone or tablet, and the Internet will be used based on that information. It is basic to access the latest package insert via and browse it electronically. This makes it possible to always use the latest information to take safety measures.

In addition to the package inserts, related documents such as examination reports can also be viewed from the barcodes attached to the boxes.

https://www.pmda.go.jp/safety/info-services/0003.html

SOUTH KOREA (MFDS)

10. Designated as an innovative medical device for ‘Automated System Robot Surgery’

Ministry of Food and Drug Safety (Chief Kang Lip Kim) Cholecystectomy, Prostatectomy etc Laparoscopy Operation on using ‘Automated system robot surgery(Operation robot)’ product is appointed as an innovative medical device.

A method of performing surgery by inserting a camera or surgical tools after making a small hole without making an incision in the abdomen or chest according to the Medical Device Industry Act.

https://www.mfds.go.kr/brd/m_99/view.do?seq=45308&srchFr=&srchTo=&srchWord=&srchTp=&itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=5

PAKISTAN (DRAP)

11. Notification: Pakistan exempts medical devices from incoming rules until 2022

The Drug Regulatory Authority of Pakistan (DRAP) has given the medical device industry until next year to comply with incoming regulations.

When Pakistan issued the Medical Devices Rules, 2017, it exempted products from the requirements for nine to 24 months, depending on their risk classification. DRAP shared details of the time-limited exemptions in a document published more than 24 months ago, in January 2018.

Now, DRAP has revised the Medical Devices Rules, 2017. The update features a new timeline for the end of the exemptions. Class D medical devices are exempt until 31 March. Class A devices are exempt until 31 December 2022. The exemptions on all other devices end over the summer and fall of next year.

The exemptions come tied to certain requirements. For example, a notarized ISO 13485 and letter of authorization from the overseas manufacturer are needed to obtain clearance for a class A medical device from Pakistan Customs. A notarized free sale certificate and declaration of conformity are needed, too. Slightly different requirements apply to lower-risk medical devices.

https://www.dra.gov.pk/docs/SRO%20526(I)2021.pdf

KAZAKHSTAN (National Center for Expertise of Medicines and Medical Devices)

12. Model contract for the provision of services for the assessment of the benefit-risk ratio of drugs and medical devices with unlimited registration

The Department of Pharmacovigilance and Monitoring of Safety, Efficiency and Quality of Medical Devices informs that within the framework of the execution of paragraph 48 § 2 of Chapter 2 of the Order of the Ministry of Health of the Republic of Kazakhstan No. and the effectiveness of medical devices “, the holders of registration certificates / applicants must conclude an agreement on assessing the” benefit-risk “ratio of drugs that have received unlimited registration with the RSE at the REM” National Center for Expertise of Medicines and Medical Devices “of the KM and FC of the Ministry of Health of the Republic of Kazakhstan according to the list …

Payment for the assessment of the benefit-risk ratio of medicines is carried out in accordance with the prices established by the authorized body in agreement with the antimonopoly body in accordance with paragraph 2 of Article 239 of the Code of the Republic of Kazakhstan on public health and the healthcare system ( prices for goods (works, services) ).

https://www.ndda.kz/rightnews/test_1620184714

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