June Newsletter

June Newsletter

EU Regulations

European Medical Device Nomenclature (EMDN) – Questions and Answers | 15 June 2021

European commission (MDCG) published a question and answers article for European Medical Device Nomenclature (EMDN). European Medical Device Nomenclature (EMDN) supports the functioning of the European database (EUDAMED). EMDN will be used for registration of medical device in EUDAMED by manufacturers. It explains the term EMDN, how EMDN is created, its key principles, structure of EMDN.

MDCG 2021-13 Questions and answers on obligations and related rules for the registration in EUDAMED of actors other than manufacturers, authorized representatives, and importers subject to the obligations of Article 31 MDR and Article 28 IVDR | 23 June 2021

The document aimed at addressing questions relating to the registration in EUDAMED of actors other than manufacturers, authorized representatives, and importers subject to the obligations of Article 31 of Regulation (EU) 2017/745 on medical devices (MDR) and/or Article 28 of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). It also clarifies the cases where an Actor ID is issued instead of an SRN.

Joint implementation and preparedness plan for Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) | 7 June 2021

European commission has issued a plan for implementation of in vitro diagnostic medical devices regulation (EU) 2017/746. This plan serves as a living document to monitor their implementation. The status and timelines of the items will be updated to reflect the progress of the work.

UK MHRA 

Operation Pangea: Officers from the Medicines and Healthcare products Regulatory Agency (MHRA) have seized millions of illegally traded medicines and medical devices | 8 June 2021

In a week of action coordinated by Interpol, this year’s ‘Operation Pangea’ ran from 18 to 25 May and saw over 100 countries joining forces to seize non-compliant medical products and to identify and remove thousands of illegally operating websites and URLs offering medicines and devices. The operation also involved coordinating the arrests of several suspected organized criminals. The MHRA will be following the week of action with a detailed analysis of the global results to create a better understanding of current and emerging threats. This work includes the identification of ‘hotspot’ exporting countries, favoured high-risk medicines being traded on the black market, and the ever-evolving business models of criminals worldwide seeking to take advantage of the public.

US FDA

Clinical Outcome Assessments (COAs) in Medical Device Decision Making | 21 June 2021

A clinical outcome assessment (COA) describes or reflects how a person feels, functions, or survives and can be reported by a health care provider or a non-clinical observer, through performance of an activity or task or by the patient. For regulatory purposes, high-quality information from COAs can provide valuable evidence for benefit-risk assessments and can be used in medical device labeling to communicate the effect of a treatment on patient symptoms and functioning. COAs may also be used to help measure the safety of the device and measure how well the device performs in treating or diagnosing the condition.

HEALTH CANADA

Off-label advertising and sale of rapid antigen tests under workplace screening program: Interim Enforcement approach | 15 June 2021

There are currently various technologies to detect SARS CoV-2, the virus that causes COVID-19. While some rapid antigen detection tests (RADTs) have been approved for people without symptoms,

most RADTs are indicated for use on people with symptoms and are to be conducted by laboratory personnel, healthcare professionals or trained operators. Health Canada has authorized several RADTs under two interim orders:

  1. 1. interim order No. 1 for importing and selling medical devices (March 18, 2020, to March 1, 2021)
  2. 2. interim order No. 2 for importing and selling medical devices (enacted March 1, 2021)

The interim enforcement discretion will be in effect until December 31, 2021. The exception is if :

  1. 1. Post-market monitoring identifies new risks or
  2. 2. There is no longer a need to apply this discretion based on public health status.

AUSTRALIA TGA

Custom made medical devices | 30 June 2021

On 25 February 2021, a new framework for regulating personalized medical devices commenced. The framework includes a new definition for custom-made medical devices. The impact of the new definition is most devices previously supplied under the exemption for custom-made medical devices no longer meet the definition of a custom-made medical device and will need to be included in the Australian Register of Therapeutic Goods (ARTG).

Medical device reforms: Conformity Assessment Bodies | 30 June 2021

Conformity assessment is the systematic and ongoing examination of evidence and the application of procedures to ensure a medical device complies with the essential principles for medical devices. Evidence that a device has undergone an appropriate conformity assessment procedure must be held by the manufacturer before a device can be included in the Australian Register of Therapeutic Goods (ARTG). Previously, Australian medical device manufacturers could only apply for a conformity assessment certificate from either the TGA or an overseas Notified Body. To provide additional flexibility and timeliness, the Australian Government agreed to regulatory changes that allow other Australian corporations that demonstrate appropriate experience and competence to undertake conformity assessment of medical devices. An Australian CAB must demonstrate they can perform product assessments and quality management system audits under the Australian conformity assessment body framework. The TGA remains responsible for including medical devices in the Australian Register of Therapeutic Goods (ARTG).

Regulatory changes for custom-made medical devices | 21 June 2021

On 25 February 2021, a new regulatory framework commenced changing the way the Therapeutic Goods Administration (TGA) regulates medical devices that are designed, manufactured, assembled, or adapted to meet the needs of an individual. The changes are collectively referred to as the personalized medical devices framework (the Framework). The Framework introduced the following:

On 25 February 2021, a new regulatory framework commenced changing the way the Therapeutic Goods
Administration (TGA) regulates medical devices that are designed, manufactured, assembled, or adapted
to meet the needs of an individual. The changes are collectively referred to as the personalized medical
devices framework (the Framework). The Framework introduced the following:

  1. New definitions for types of personalized medical devices, greatly reducing the number of devices
    that can be supplied under the custom-made medical device exemption.
  2. New conditions of exemption for custom-made medical devices, in the form of requirements to:
    • submit an annual report detailing all custom-made medical devices supplied in the previous
    financial year.
    • Allow the TGA to inspect production facilities.
    • retain documentation about custom-made medical devices for 5 years (for Non implantable devices)
    or 15 years (for implantable devices).
    • Provide information about each custom-made medical device to the intended recipient.
  3. The new concept of a Medical Device Production System (MDPS) which, once fully implemented,
    will provide options to healthcare providers wishing to produce personalized devices for treating
    their patients and updates to the classification rule for medical devices that record diagnostic images
    to include a broader range of technology now used for the purposes of recording patient anatomy for
    diagnosis and investigation, including anatomical models.

SINGAPORE HSA 

Mean applicant screening response time | 23 June 2021

HSA strives to complete the screening of the new and major variation applications in the shortest possible time. For the new and major variation applications accepted within the period of 01 Oct 2020 to 31 Mar 2021, the mean screening time taken by HSA was 31.9 Working Days (WD) for New Drug Application (NDA), 33.6 WD for Generic Drug Application (GDA) and 19.2 WD for Major Application Variation (MAV) applications, respectively.

Below are bi-annual updates of the mean applicant response time for the new and major variation applications:

Mean Applicant Response Time
Period NDAGDAMAV
01 Oct 2020 to 31 Mar 2021Number of applications6210979
Mean Applicant Response Time (WD)33.240.217.0

PAKISTAN DRAP

Notification regarding amendments in form-2 of the Medical Devices Rules,2017 | 7 June 2021

The Drug Regulatory Authority of Pakistan (DRAP) on recommendation of the Medical Devices Board, made the following amendments in Form-2 sub-rule (3) of rule 63 of the Medical Devices Rules, 2017: The entries in column (2) at sub-serial number (iv) and (viii) of serial number 2 shall be omitted and remaining entries shall be renumbered accordingly.

SWITZERLAND SWISSMEDIC

Information from Swissmedic about MedDO | 19 June 2021

If the manufacturer of a medical device does not have its registered place of business in Switzerland, its products may only be placed on the market once an authorized representative domiciled in Switzerland has been appointed (Art. 51 para. 1 MedDO). This also applies to manufacturers with their registered place of business in the EU. The transitional periods defined in Art. 104a MedDO apply to the authorized representative.

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