Regulatory authority The Food and Drugs Authority (FDA) is the government agency responsible for medical device regulation in Ghana in addition to cosmetics, household chemical substances, food, drugs, herbal medicinal products, tobacco, blood and blood products, and the regulation of…
Guidance has been published to explain the requirements for obtaining an importation licence and a shipment clearance for distillation apparatus1. The requirements apply to importers of distillation apparatus imported for healthcare providers or medical educational facilities, or non-governmental healthcare providers…
New guidance (MDS-G18) has been published by the Saudi Food and Drug Authority (SFDA) to clarify the requirements for the importation of medical devices, including in vitro diagnostics (IVDs), and non-medical IVDs intended for educational or non-clinical research purposes1. Medical…
MDCG 2021-271 provides answers to 20 questions plus three practical examples on the requirements that apply 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). The…
Swissmedic’s leaflet on the procurement of medical devices in health institutions has been updated in January 20221. Chapter 7 now clarifies that: ‘For the reasons already stated, healthcare professionals and institutions should usually procure products from a Swiss manufacturer or…
On 13 November 2021, the Brazilian National Health Surveillance Agency (ANVISA) cancelled1 the simplified process for importing medical devices used in health services to expand their availability during the COVID-19 public health emergency, as set out in Resolution RDC No.…
Guidelines have been released by the Egyptian Drug Authority on the procedures and rules that apply to obtaining import approvals for laboratory and diagnostic devices and their imported accessories1. Topics covered include the following: procedures for obtaining import approvals…
Comments are being accepted on a proposal to insert a new section 43A on the suspension and cancellation of import licences for medical devices for personal use1 in the Medical Devices Rules, 2017. The proposed new text would read as…
The Brazilian National Health Surveillance Agency (ANVISA) has extended by 60 days1 the simplified process for importing medical devices used in health services to expand their availability during the COVID-19 public health emergency, as set out in Resolution RDC No.…
A period of public consultation has been held on a proposal to amend Resolution RDC No. 172 of 8 September 2017, which sets out the procedures for the import and export of goods and products intended for scientific or technological research…
Guidance has been issued for manufacturers/importers with respect to the voluntary/mandatory registration of medical devices1. Firstly, the Central Drugs Standard Control Organization has set out the initial steps to be followed by manufacturers/importers for the registration of non-notified medical devices:…
On 8 September 2021, the Directorate of Medicine and Pharmacy (DMP) released an Information Note (No. 1023 D/DMP/18) relating to establishments manufacturing and importing drugs and health products1. Within the context of managing the COVID-19 pandemic, the DMP has put…
A partial revision of the Medical Devices Act will come into force on 21 January 2022 (Legal No. 18319), six months after its date of publication1. Among the changes, Article 18-2 will be added to Chapter 3(4) to specify that no-one…
Introduction As the standard of living continues to rise in Thailand and around the world, people continue to demand better healthcare. Better healthcare can come in many forms, from early detection diagnostics utilising artificial intelligence to wearable technology. Heavily relying…
Since 16 July 2021, Health Canada is no longer accepting applications for thermometers and ventilators1 under Interim Order No. 2, Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-192, as these devices are no longer…
Comments have been solicited on Draft Resolution No. 1049, dated 27 May 2021, which sets out the requirements for the approval of ‘compassionate use’ programmes for medical devices1. This Resolution applies to programmes for the compassionate use of medical devices…
On 1 May 2021, several new regulations came into force to support the region’s new Medical Devices Act, which formally separates the regulation of medical devices from pharmaceuticals. A list of these regulations is provided below, along with links to…
Royal Decree No. (M/54) has approved the new Medical Devices and Supplies System Regulation1, which will eventually replace the Medical Devices Interim Regulation. The following activities are subject to the provisions of the new Regulation: designing and manufacturing of…
In an effort to unify and streamline regulations on the management of medical devices in Vietnam, the Ministry of Health (MoH) has drafted a new Decree intended to replace the three current Decrees on medical device management (Decree No. 36/2016/ND-CP…
On 1 March 2021, Interim Order No. 2 Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-191 (IO No. 2) was signed by the Minister of Health, repealing and replacing the previous Interim Order…
The Brazilian Health Regulatory Agency (ANVISA) has simplified the process for importing medical devices used in health services to expand their availability during the COVID-19 public health emergency1. The Resolution of the Collegiate Board (RDC) No. 483/2021 allows the direct…
New rules are being implemented/enforced with respect to the registration and circulation of laboratory and diagnostic reagents (IVD reagents)1. Since 1 April 2021, it is prohibited to import laboratory or diagnostic reagents into Egypt without prior import approval from the…
Rules have been drafted1 to control the border inspections and examination of imported condoms (including those with spermicidal lubricant), general medical masks, surgical masks, and N95 medical masks. To import these medical devices, the applicant (importer) must submit a completed…
Brexit has resulted in substantial changes to the way in which medical devices are imported from Great Britain to Ireland. The Health Products Regulatory Authority of Ireland (HPRA) has therefore reminded1 device companies about the changed processes and outlined the…
On 25 September 2020, the National Medical Products Association (NMPA) announced a simplified registration route to be followed when the production of imported medical device products moves to China1. To be eligible, the imported medical devices must be in Class…
Six guidance document revisions have been issued recently by the Saudi Food and Drug Authority (SFDA): MDS-G21, Guidance on Requirements of Shipments Clearance at Ports of Entry, version 4.0, 20 October 20201 The purpose of this guidance is to clarify the…
In response to the COVID-19 pandemic and to ensure the safety and well-being of the public, the Ministry of Health and Welfare has adopted1 the proposal of 30 June 20202 to conduct on-site quality inspections and examinations of imported medical…
In response to the extra demand for essential health products created by the COVID-19 pandemic, the Spanish Agency for Medicines and Health Products (AEMPS) issued a number of extraordinary import authorisations for health products to address those needs. As the…
In May 2020, the Brazilian Health Regulatory Agency (Anvisa) published an Information Note to clarify what lung ventilators are, how they work, and the actions taken by Anvisa to facilitate access to them in the context of COVID-191. Anvisa has…
An update has been published1 to the Brazilian Health Regulatory Agency’s (Anvisa’s) rules for the manufacture, import and acquisition of medical devices identified as indispensable for use in the healthcare services because of the COVID-19 pandemic. Such devices include surgical…
Act No. 17248, dated 7 April 2020, has amended Article 49 of the Medical Devices Act with respect to the renewal of manufacturing permits1. With effect from 8 October 2020, manufacturing permits, manufacturing certifications, manufacturing reports, import permits, import certifications,…
Guidance has been drafted to clarify the requirements for importers wishing to obtain shipment clearance for products subject to Saudi Food and Drug Authority/Medical Devices Sector (SFDA/MDS) regulation at the Saudi ports of entry1. Regulated products covered by this draft…
In response to the COVID-19 pandemic and to ensure the safety and well-being of the public, the Ministry of Health and Welfare has proposed conducting on-site quality inspections and examinations of imported medical masks1. The inspections would apply to general…
On 5 March 2020, the National Medical Products Administration (NMPA) circulated for comment an Announcement on the Transfer of Medical Devices with Imported Registration Certificates to Chinese Enterprises for Production (Draft for Comment)1. Under this pathway, applicants would be able…
A partial revision of the regulations concerning exemptions from the medical device import requirements has been published to improve the operational shortcomings of the system1. The revisions expand the scope of medical devices that are required to obtain manufacturing licences…
New guidance (MDA/GD/0018) has been published to clarify the requirements for notification of importation and/or supply of medical devices of all risk classes intended solely for the purpose of demonstration for marketing or education1. The guidance document explains the process…
Vietnam’s Ministry of Health has released a new Decree No 03/2020 (effective 1 January 2020) on the management of medical devices in Vietnam1,2. Decree No 03/2020 has amended and supplemented provisions in Article 68 of Decree No 36/2016/ND-CP dated 15…
Comments are being accepted until 3 November 2019 on a Technical Regulation for Medical Devices and Accessories, which has been drafted by the Ministry of Industry, Commerce & Tourism in coordination with National Health Regulatory Authority (NHRA)1. The purpose of…
All applications for new import permits, as well as for modifications to existing import permits, must now be submitted electronically through the Mexican Digital Window of Foreign Trade (la Ventanilla Digital Mexicana de Comercio Exterior)1. The new rules apply to…
Market overview It is estimated that local manufacturers only meet 10% of the market demand for medical devices in Vietnam, while 90% of medical devices are imported, especially advanced technology like diagnostic imaging equipment. Local manufacturers have only been able…
A Provision has been published1 that sets out the process for requesting authorisation from the National Medical Products Directorate for the importation of medical products, including used medical products and in vitro diagnostics (IVDs). Applicants must use the Platform of…
In order to enable Canada to conform to its international trade obligations under the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP), regulatory amendments to the Medical Devices Regulations (MDR)1 and the Radiation Emitting Devices Regulations (REDR)2 were required. The…
Legislative framework Medical devices are governed by Supreme Decree No 825/98 (Regulations with Control of Medical Use Products and Elements1) and Decree No 725 (the Sanitary Code2). Legislation dates from 1997, when medical devices were included in the Sanitary Code.…
On 18 September 2018, the Saudi Food and Drug Authority (SFDA) issued MDS-G29, Guidance for the Medical Devices Samples for Laboratory Testing, version 1.01. The purpose of this guidance is to clarify the procedure for laboratory testing of medical device…
A Circular has been issued1 that sets out an updated policy for the implementation and enforcement under the Medical Device Act 2012 for medical devices imported from/exported to countries without diplomatic ties with Malaysia (e.g. Israel). This revised policy states…
Comments have been sought on a proposed Regulation for the Supervision and Administration of Chinese Agents of Imported Medical Devices1. The purpose of the Regulation is to strengthen the supervision and administration of imported medical devices, to regulate Chinese agents…
The National Health Surveillance Agency (ANVISA) has clarified the procedure for dealing with cases of divergence between shelf-life information contained in the product registration and in the import process1. An example would be when the shelf-life specified in the medical…
Regulatory authority The Competent Authority for medical devices in Zimbabwe is the Medicines Control Authority of Zimbabwe (MCAZ). This Agency is responsible for, inter alia, control and assessment of the quality of medical devices, and issuing registrations and distributor registration…
Updated guidance has been published to clarify the requirements that importers must follow in order to obtain shipment clearance1 at the country’s ports of entry for products subject to Saudi Food and Drug Authority (SFDA) regulation. The primary changes from…
GN-07, Guidance Notes for Listing of Importers of Medical Devices1, has been fully revised by the Medical Device Control Office (MDCO). Corresponding changes have also been made to COP-04, Code of Practice for Listed Importers of Medical Devices, and Form…
