vidence submitted in regulatory submissions reviewed by FDA staff. This draft guidance is not for implementation.
Center for Devices and Radiological Health Appeals Processes | 17 February 2022
The Food and Drug Administration (FDA / Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with certain Center for Devices and Radiological Health (CDRH) appeals processes.
Establishment Registration and Device Listing for Manufacturers and Importers of Devices | 07 February 2022
The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with establishment registration and device listing for manufacturers and importers of devices.
BRAZIL
ANVISA publishes standard on simplified analysis of clinical research | 23 February 2022
On 16 February 2022, in the Official Gazette (D.O.U), ANVISA published the Resolution of the Collegiate Board (RDC) 601/2022, which provides simplified analysis, on an exceptional and temporary basis, of clinical research petitions. the standard deals with a regulatory measure to cope with an emergency, as provided for in item I, art. 39 of Ordinance 162/2021. The measure seeks to quickly release petitions for medical research, provided that these petitions have been authorized by regulatory authorities of remarkable recognition.
ANVISA approves the registration of the first self-test for Covid-19 in Brazil | 17 February 2022
To grant registration, ANVISA analyses several technical requirements, including usability and risk management, which serve to adapt the product to use by lay people, ensuring greater security. Guidelines on usage of the product can be found here.
ANVISA prohibits collection kit for testing and diagnosis of Covid-19 without registration | 16 February 2022
ANVISA clarifies that these products can only be marketed in the country after registration.
Regulating remote inspections| 14 February 2022
ANVISA published a document with questions and answers on the regulation of remote inspections of imported goods and products subject to sanitary surveillance in ports and airports in the country by the modality of the Integrated System of Foreign Trade (SISCOMEX). The objective is to allow the regulated sector to carry out inspections remotely on goods whose Import Licensing (IL) is under analysis by the Agency. According to the rules of Resolution of the Collegiate Board (DRC) 597/2022 published in the Official Gazette (D.O.U.), the standard will enter into force on 2 March 2022.
CANADA
Publication of third Interim Order respecting the importation and sale of medical devices (COVID-19): Notice to manufacturers, purchasers, and users | 21 February 2022
To accelerate access to certain medical equipment in Canada during the pandemic, Health Canada issued two interim rules on the importation and sale of medical devices for use in respect to COVID-19. On March 18, 2020, the first interim order was issued, and on March 18, 2020, the second interim order was issued. As Interim Order No. 2 was set to expire on 1 March 2022, Health Canada has put in place a third interim order. The first and second interim orders expedited the regulatory procedure for approving the importation or sale of medical devices used to diagnose, treat, mitigate, or prevent COVID-19 while ensuring that safety, efficacy, and quality requirements were satisfied. The goal of Interim Order No. 3 is to keep the same flexibility that Interim Order No. 2 provided. Unless otherwise specified, all application conditions remain the same as in the second interim order. As a result, all active authorizations and expanded use indications under Interim Order No. 2 will be continued under Interim Order No. 3. The manufacturer will not be obligated to take any action. Manufacturers of permitted devices under Interim Order No. 2 may continue to import and sell their products in Canada. Any terms and conditions imposed on an interim order authorisation issued under Interim Order No. 2 remain in effect. Manufacturers must continue to operate under the same conditions as before. Interim Order No. 3 will remain in place for up to 1 year.
Regulations to allow exceptional importation of medical devices to address shortages as of 2 March 2022 | 16 February 2022
Amendments to the Medical Devices Regulations (MDR), published in Canada Gazette, Part II in September 2021, come into force on March 2, 2022, which will allow the exceptional importation and sale of medical devices to help address shortages in Canada. Current provisions allowing the exceptional importation and sale of devices related to COVID-19 are set out under Interim Order No. 2 which will no longer be in effect after 1 March 2022. The amendments to the MDR allow medical devices that would not otherwise meet Canada’s regulatory requirements to be imported and sold. However, these devices must meet the following conditions:
- the device is a substitute for one that is in shortage or at risk of being in shortage
- the device is authorized for sale in another jurisdiction
- the device is manufactured to quality standards comparable to those in the MDR
- the importer has a medical device establishment licence (MDEL)
- the importer informs Health Canada at least 5 business days before importing the device
SINGAPORE
Guidance on Medical Device Product Registration | 07 January 2022
The Health Sciences Authority (HSA) has amended the guidance document meant to assist applicants in the registration of medical devices under the Act and Regulations. This guidance document describes the procedures and general requirements for the submission of an application for a new Product Registration for medical devices. The document can be found here.
Guidance on Grouping of Medical Devices for Product Registration (Revision 2) | 07 January 2022
This version of GN-12 guidance document applies to all medical device registration applications submitted to HSA. The grouping criteria described in the GN-12-1 and GN-12-2 shall be strictly adhered to in submitting your medical devices for registration. This document is meant to provide guidance on the device specific criteria in determining whether certain models of specific medical devices can be included together and submitted in one product registration application. Grouping of medical devices for product registration facilitates the inclusion of multiple devices in one application.
BAHRAIN
Medical devices registration fast-track communication and delivery of services | 06 February 2022
The National Health Regulatory Authority (NHRA) announced a partnership with Adliya Business Center CO. W.L.L (ABC) as a private agency for instant communication and delivery of services for medical device registration, to help applicants who are having trouble preparing the required documents, and to speed up the registration process. Applying through Adliya Business Center CO. W.L.L (ABC) is optional, as applicants can submit directly to NHRA.
Medical devices registration fast-track communication and delivery of services | 06 February 2022
In accordance with decision (48) of 2020 related to medical devices regulations, The National Health Regulatory Authority (NHRA) notified all the importers and shop owners, especially those who are selling medical and cosmetic lenses, about the necessity of verifying that the lenses are approved by NHRA.
Cases that will not be included in the medical device’s regulation | 06 February 2022
Based on the resolution no. (48) for the year of 2020, NHRA clarified that the following medical devices will not be subjected to registration:
- Medical device imported for healthcare facilities for:
- Emergency
- A single time and not planned to be imported on a regular basis
- Medical devices imported for research and educational purposes
- Personal imported medical devices
- Custom-made medical devices or order for specific patient
- Samples for exhibition and conferences
INDIA
Regulation of sale of medical devices via registration of premises under MDR, 2017 | 09 February 2022
A draft of certain rules further to amend Medical Device Rules 2017, published after consultation with the Drugs Technical Advisory Board for information of all persons likely to be affected thereby, and notice is given that the said draft rules shall be taken into consideration on or after the expiry of a period of forty-five days from the date on which copies of the Gazette of India containing these draft rules are made available to public. Objections and suggestions which may be received from any person within the period specified above will be considered by the Central Government. The draft rules can be accessed here, page 7.
