On 25 February 2026, the South African Health Products Regulatory Authority (SAHPRA) published a Guideline for Licence Applications for Non-ionising Radiation Medical and Non-medical Devices Classified as Listed Electronic Products (SAHPGL-RDN-NM-01)1. The selling, letting, use, application, installation, manufacture, and importation…
Comments have been sought on draft Guidelines on the Maintenance of Importation and/or Distribution Records, and the Reporting of Product Complaints, Adverse Events, and Field Safety Corrective Actions for Medical Devices1. The purpose of these Guidelines is to establish requirements…
The guidance document MDA/GD/0066, Importation of medical device for personal use, has been officially withdrawn. However, all information previously contained in the guidance document will continue to be made available on the MDA website for regulatory reference1. Reference 1. …
Guidance has been drafted1 for importers to assist them in the submission of product licence applications to the Central Drugs Standard Control Organisation (CDSCO) through ‘cdscomdonline’ and the National Single Window System (NSWS). The draft guidance specifies the information required…
In the event of a discrepancy between the country of origin stated in the marketing certificates and the country indicated on the invoices and labels, the provisions of Regulation (EU) No 952/2013 (European Union Customs Code) shall apply to items…
Provision 224/2026 from the National Administration of Drugs, Food and Medical Devices (ANMAT) has amended the procedure governing the importation of used and refurbished medical devices1. The new regulations, which replace ANMAT Provision 806/2007, align the health regulations with the…
Provision No. 236/2026 has entered into force, establishing a new, simplified registration procedure for the importation and marketing of certain medical products1. Under this Provision, the submission of a sworn statement (Declaración Jurada) is now required for imported medical products…
Revisions of several guidance documents were published in October 2025: GN-34: Guidance Document for IVD Analysers1 The second revision of GN-34 provides updated guidance to product owners and registrants concerning in vitro diagnostic (IVD) analysers and their associated accessories.…
In April 2025, the new medical device ePermit System went live1 to facilitate import permit applications for medical devices and verification slip applications for non-medical devices that fall under the medical device tariff codes. Mandatory use of the ePermit System…
On 31 December 2025, the following five guidance documents were updated with immediate effect: GN-07, Guidance on Listing Matters for Medical Device Importers1 Section 8.2.2 has been added to read: ‘8.2.2 If the existing importer list has expired, the…
The Egyptian Drug Authority has announced the issuance of import approvals for refurbished spare parts for medical and laboratory equipment that are not classified as standalone devices1. Companies that import refurbished spare parts for medical and laboratory equipment that are…
The Egyptian Drug Authority (EDA) has published1,2 guidance on the basic requirements for accepting import approval requests for medical equipment and their spare parts via the MeDevice Platform. As part of the EDA’s efforts to streamline procedures for receiving such…
The National Administration of Drugs, Food and Medical Devices (ANMAT) has released an updated framework for accrediting compliance with technical requirements through the recognition of international certifications1. ANMAT Decree No. 892/2025 applies exclusively to medical products of risk Classes I…
On 18 August 2025, the Central Administration for Pharmaceutical Policies and Market Support and the Central Administration for Medical Supplies issued a regulatory guide1 on the rules and procedures governing the import and export of samples of medical supplies, laboratory…
Rules to control the border inspections and examination of imported condoms (including those with spermicidal lubricant), general medical masks, surgical masks, N95 medical masks, and COVID-19 self-test kits have been amended1. Amendments to Attachment 1 of Article 3, Attachment 2…
New guidance has been published (MDA/GD/0069)1 that specifies requirements for an application for exemption of a medical device for the purpose of importation for re-export, in accordance with the Medical Device (Exemption) Order 2024. Importation, placement and supply of a…
On 14 April 2025, the new medical device ePermit System went live1 to facilitate import permit applications for medical devices and verification slip applications for non-medical devices that fall under the medical device tariff codes. Mandatory use of the ePermit…
Announcement No. 30 of 2025 has been published to amend and optimise matters relating to the manufacture of imported medical devices1. The foreign-invested companies referred to in the Announcement may be companies established by the registrant of imported medical devices,…
Since publication of ANMAT Provision No. 2565/25, imported medical products and their accessories may not enter Argentina if their expiration date is less than six months1. However, medical products and their accessories included in Article 1 and with a useful…
Interested parties have until 3 February 2025 to submit comments on the second edition of the guidance document MDA/GD/0066, Importation of Medical Device for Personal Use1. This guidance document has been designed to assist individuals who intend to bring any…
The Egyptian Drug Authority has announced1 that as of 10 January 2025, companies wishing to apply to the Scientific Committee and obtain import approvals for medical supplies and devices classified in Class IIb and Class III must commit to submitting…
In response to recent amendments to the Tariff Codes, and the Fee-Charging Standards for Lot Release, Reference Materials, and Testing of Foods, Drugs and Cosmetics, Attachment 1 of Article 3, Attachment 2 of Article 6, and Attachment 3 of Article…
In September 2024, the Ministry of Health published Official Dispatch No. 365/HTTB-ĐKKD1 regarding applications for a licence to import medical equipment submitted before 1 January 2022 where the import licence has not yet been granted. For import dossiers submitted before…
The Egyptian Drug Authority has published procedures for local factories to follow to import fully manufactured samples of medical and laboratory supplies and devices, and laboratory and diagnostic reagents, for non-commercial purposes (i.e. research and development, validation or evaluation, reverse…
On 22 September 2024, the Egyptian Drug Authority announced1 that with regard to the registration files for sterile parts of imported dental implants that have obtained an initial acceptance number from the General Administration of Registration at the Central Administration…
Administrative requirements for the temporary importation and use of medical devices by medical institutions to meet an urgent clinical need have been issued and implemented in China through publication of Announcement No. 97 of 20241. These requirements clarify the obligations…
The Egyptian Drug Authority (EDA) has set out1 the procedures to be followed in case of expiry of quality certificates for medical supplies and devices issued under the former European Directive 93/42/EEC on medical devices. In accordance with the implementation…
As reported previously in the Journal, all non-notified Class C and D medical devices that were under mandatory registration moved to the licensing regime with effect from 1 October 20231 and now require a manufacturing/import licence to be placed on…
Circular Letter No. 1/2024 sets out the implementation and enforcement policy relating to medical devices that are imported from, or exported to, countries without diplomatic ties with Malaysia that are subjected to trade restrictions1. Although the Medical Device Act 2012…
New guidance MDA/GD/0066, Importation of Medical Device for Personal Use, has been published1 to outline the requirements for the importation of personal use medical devices. The guidance applies to all home use medical devices that fall within the definition of…
Regulatory authority The Iranian Food and Drug Administration (IFDA) is an independent agency which operates under the Ministry of Health and Medical Education and oversees the evaluation, classification, registration, licensing, and importation of all medical devices. The head of the…
A first revision has been released1 of the guidance that presents questions and answers on requirements relating to importers and distributors under Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).…
From 1 January 2024, any applicant that is deemed to be guilty of repetitive violations by the National Health Regulatory Authority (NHRA) will no longer be eligible1 for the exemptions for medical device importation provided for under Circular 23/2020. In…
The format of establishment registration certificates for medical device manufacturers and importers has been amended. The establishment registration certificate for medical device manufacturers will follow the format of the newly amended Form B.S.P.11, while the establishment registration certificate for medical…
Comments have been solicited on a draft guidance document entitled Importation of Medical Device for Re-Export (IRE)1. This guidance is intended to clarify the requirements and notification process for an applicant (e.g. an established company in Malaysia, licensed establishment or…
In August 2023, the Medical Device Authority (MDA) published a draft guidance document entitled Importation of Medical Device for Personal Use for public comment1. This document is intended to inform the public on the guidelines for bringing (importing) medical devices…
Introduction Medical devices, along with medicines, are basic elements of any healthcare system. Both medicines and medical devices need to be regulated in order to guarantee their quality, efficacy and safety when used by a patient. In Tunisia, medicines have…
The National Health Surveillance Agency (Anvisa) has updated its Medical Device Import Manual to provide the latest information to importers on the rules for submission and analysis procedures for medical device import processes under the responsibility of the Health Product…
New guidance has been published for medical product manufacturers, suppliers, donors, importers, health institutions, and recipients on the regulatory requirements that apply to the special import permit system1. The guidance should also assist Ethiopian Food and Drug Authority experts on…
The Central Drugs Standard Control Organisation has reminded stakeholders that all non-notified Class C and Class D medical devices that are currently under mandatory registration will come under the licensing regime with effect from 1 October 20231. From this date, these…
On 3 March 2023, the Vietnamese government issued Decree No. 07/2023/ND-CP1 amending Decree No. 98/2021/ND-CP on the management of medical equipment to extend certain transitional arrangements and make several other changes and additions to the regulatory requirements for medical devices…
The National Administration of Drugs, Food and Medical Technology (ANMAT) has further extended1 until 30 June 2023 its exception of the sanitary registration requirements for the import of face masks, chinstraps, examination gloves (excluding sterile gloves), and infrared (IR) thermometers.…
Circular No. (2) of 17 January 2023 announces the initiation of scope verification for Authorised Representatives as part of the importation applications’ review process1. As a result, any importation shipment that is not within the Authorised Representative’s registered scope will…
The National Institute for Drug and Food Surveillance’s (INVIMA’s) Directorate of Medical Devices and Other Technologies has issued Circular No. 5000-0001-221 to clarify and update guidelines on the application of Decree 4725 of 2005. It is hoped that this will…
Food and Drug Administration (FDA) Circular No. 2017-013-A has been published1 to align and amend FDA Circular No. 2017-013 with provisions of Department of Health Administrative Order No. 2018‑0002, and to provide guidance for medical radiation devices in line with…
Circular No. 05/2022/TT-BYT, dated 1 August 2022, sets out details for the implementation of several Articles of Government Decree No. 98/2021/ND-CP on the management of medical equipment1. The Circular, which took immediate effect: sets rules for the classification and…
The Medical Devices (Third Amendment) Rules, 2022 have added a new section 43A on the suspension and cancellation of import licences for medical devices1 into the Medical Devices Rules, 2017. The new text reads as follows: ‘43A. Suspension and…
New guidance has been released on the requirements for obtaining clearance at the Ethiopian ports of entry for medical devices, including in vitro diagnostics (IVDs)1. Medical devices may be imported by medical devices importers, government and non-governmental health institutions, clinical…
In February 2022, the Ethiopian Food and Drug Authority issued the 76-page Medicine and Medical Device Import, Export, and Wholesale Control Directive No. 872/20221 in accordance with Article 71(2) of the Food and Medicine Administration Proclamation No. 1112/2019. Any person…
Interim Order No. 3, Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19, has been approved1 for one year to replace Interim Order No. 2 (March 2021). This third Interim Order maintains all the flexibilities…
