Guidance (SAHPGL-MD-21) has been provided on obtaining a Certificate of Free Sale (CFS), which serves as confirmation that the listed medical devices, including in vitro diagnostic medical devices (IVDs), are legally sold or distributed, without restriction, in South Africa1. The…
Certificates of Free Sale, Manufacturing Certificates and Export Certificates will be issued electronically from 1 March 20261. Upon completion of the application and successful payment, the electronic certificate will be issued by the Medical Device Authority via email within seven…
Comments have been solicited on the draft first version of SAHPGL-MD-21_v1, Guideline for Medical Device Certificate of Free Sale1. The purpose of this Guideline is to set out the process and requirements for applicants that manufacture medical devices, including in…
To support the export trade of medical devices and standardise the handling of service matters relating to the issuance of export sales certificates for medical devices by drug regulatory authorities, the National Medical Products Administration has revised and reissued the…
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…
Comments have been sought on the second edition of MDA/GD/0051, Medical Device for the Purpose of Export Only1. This guidance document specifies requirements for an application for exemption from the registration requirements for medical devices destined for export only, in…
The application links for obtaining a Certificate of Free Sale (CFS) for a medical device or an in vitro diagnostic reagent became live in June 2025. To obtain a CFS for a medical device, the Google form Application for a…
Since 13 February 2025, all Certificates of Free Sale (CFSs) for medical devices, cosmetics, personal care products, and biocides under the jurisdiction of the Spanish Agency for Medicines and Medical Devices (AEMPS), as well as export certificates for medical devices,…
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…
The Health Products Regulatory Authority has updated the process for applicants to follow when requesting Certificates of Free Sale (CFSs) for medical devices1. It is hoped that these changes will create a more efficient application process for both applicants and…
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…
In order to streamline1 the process for issuing a Neutral Code to an applicant for manufacturing medical devices for export purposes, applications may now be submitted digitally via the Online System for Medical Devices portal2. The Neutral Code will be…
Since 2 January 2024, the Food and Drug Administration (FDA) will only issue electronic export documents for medical devices rather than paper documents1. Switching to electronic PDF documents improves efficiency in issuing export documents, reduces the amount of time it…
Guidance entitled Process to Request a Review of FDA’s Decision Not to Issue Certain Export Certificates for Devices – Guidance for Industry and Food and Drug Administration [FDA] Staff has been updated1. The updated guidance includes minor changes to align…
If a country only issues Certificates of Free Sale (CFSs) in digital format, certain rules need to be followed before those certificates will be accepted in Panama1. Manufacturers must print out the CFS that was provided to them digitally and…
With effect from 1 October 2023, a Certificate of Free Sale (CFS) will only be issued for registered medical devices, so CFSs for export-only medical devices will no longer be issued1. CFSs for export-only medical devices that were issued before…
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…
On 1 August 2023, an amendment was published1 to Act 362/2011 Coll. on medicines and medical devices, which also amended certain laws. This amendment is a temporary version that is valid from 1 August 2023 until 31 December 2023. On…
A new Certificate of Free Sale (CFS) application form for medical devices qualifying under Regulation (EU) 2023/607 (so-called ‘legacy’ devices) has been developed by the Health Products Regulatory Authority1. This application must be accompanied by a declaration of conformity, manufacturer…
In December 2023, the Food and Drug Administration (FDA) plans to begin transitioning from paper export documents for medical devices to electronic export documents1. The documents that will be issued electronically include: Certificates to Foreign Government; Certificates of Exportability…
Section 3304 of the Consolidated Appropriations Act, 2023 amended section 801(e)(4) of the Federal Food, Drug and Cosmetic Act (FFD&C Act) and directed the Food and Drug Administration (FDA) to provide certification for devices that are not exported from the…
Based on the success of its pilot project, Health Canada has decided to replace permanently the paper-based process for requesting a manufacturer’s certificate to export (MCE) with an electronic process. It has therefore updated the guidance document GUI-0097 to reflect…
Comments were accepted until 13 January 2023 on a second edition of MDA/GD/00451. This draft guidance on application requirements proposes extending the scope from export-only Certificates of Free Sale (CFSs) to other CFSs and manufacturing certificates. The first edition of…
The Competent Authorities for Medical Devices (CAMD) has released a question-and-answer document1 to provide guidance to Member States and economic operators on the issuance of Certificates of Free Sale (CFSs) under Article 60(1) of Regulation (EU) 2017/745 on medical devices…
An updated schedule of fees payable under the Medicines Act 1981 became effective on 1 July 20221. A Regulatory Statement to Foreign Government for a medical device now costs NZ$186 per statement. Reference 1. https://www.medsafe.govt.nz/regulatory/FeesScheduleJuly2022.pdf
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…
Country Electronic applications Timeframe Application process and documents required Fees Comments Germany Depends on the regional Competent Authority About 2 weeks Application forms vary from region to region, therefore the regional Competent Authority needs to be identified first. Documents usually required…
The Medical Device Authority has announced a policy decision regarding the implementation and enforcement of certain registration and labelling requirements for export-only medical devices1. All medical devices for export only, regardless of their class, are exempt from the conformity assessment…
[This chart cannot be displayed in this search and must be viewed directly from the February 2022 Journal PDF.] Country Electronic applications Timeframe Application process and documents required Fees Comments Ireland ü About 10 working days after validation of the…
On 5 January 2022, Health Canada launched a six-month pilot project to implement an electronic version of the manufacturer’s certificate to export (MCE)1. Once the pilot is over, the former paper-based process, which was halted in March 2020 because of…
The process by which the Brazilian National Health Surveillance Agency (ANVISA) will issue electronic only Product Certificates (notification certificates or medical device registrations) and Certificates to Foreign Government (notification or registration certificates for exporting medical devices) has been set out…
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…
[This chart must be viewed directly from the November 2021 Journal PDF.] Country Electronic applications Timeframe Application process Documents required Fees Comments France X 3–10 days Download relevant documents from the CCIR website. Complete, print and sign the Application Form…
The process by which the Therapeutic Goods Administration (TGA) includes Class I non-measuring, non-sterile medical devices in the Australian Register of Therapeutic Goods (ARTG) changed on 1 October 2020 and, in December 2020, this change was extended to Class 1 in…
Following statutory revisions introduced by the Coronavirus Aid, Relief, and Economic Security (CARES) Act, the Food and Drug Administration (FDA) has implemented1 a certification for medical devices not exported from the USA. If certain requirements are met, a Certificate for…
Since the beginning of October, all applications for Certificates of Free Sale, Market Standing Certificates, and Non-Conviction Certificates for notified medical devices must be made online via the specific medical device portal: https://cdscomdonline.gov.in/1. These certificates will continue to be issued…
The CERTPS application system has been launched by the Spanish Agency for Medicines and Health Products (AEMPS) to facilitate the management of Certificates of Free Sale (CFS) for exported medical devices1. Medical devices produced in Spain exclusively for export do…
The Health Products Regulatory Authority of Ireland has issued another update to AUT-G0026, Guide to applications for certificates of free sale for medical devices1. The changes are largely administrative and have been used to simplify/clarify the text. The previously requested…
Final guidance entitled, Process to Request a Review of FDA’s [Food and Drug Administration’s] Decision Not to Issue Certain Export Certificates for Devices, was published in late 20191,2. This guidance specifies the process by which persons may seek a review…
Interested parties have until 3 February 2020 to submit comments on proposed changes to the guidance on Export certification for medical devices – Applying for a Certificate of Free Sale or an Export Certificate1. This second version of the guidance…
On 1 July 2019, a new schedule of fees payable under the Medicines Act 1981 came into effect1. The new fee for a medical device Regulatory Statement to Foreign Government (per statement) is NZ$178.25. Reference 1. https://www.medsafe.govt.nz/regulatory/Fees/New%20Fees.pdf
New guidance has been developed to assist in the notification of export-only medical devices, including in vitro diagnostic medical devices1. The importation, exportation, or placement of a medical device in the Malaysian market requires the medical device to be registered…
Guidance has been drafted (MDA/GD/0051) on the requirements for notification of export-only medical devices1, including export-only in vitro diagnostic medical devices, to the Medical Device Authority (MDA). The importation, exportation or placement of a medical device in the Malaysia market…
Amended ordering requirements for Certificates of Free Sale (CFS) came into effect on 13 February 20191 to take account of experience gained with the new issuing process that was introduced during 2018. Problems had been unexpectedly common, especially with grouping medical devices,…
The Medical Device Authority of Malaysia has issued a new guidance document (MDA/GD/0045) outlining the application requirements for a Certificate of Free Sale (CFS) for export-only medical devices, including in vitro diagnostic medical devices1. This scope of the guidance extends…
Guidance has been issued to Indian manufacturers on the application process for Certificates of Free Sale (CFSs) for notified medical devices1. The guidance document applies to those medical device manufacturers who intend to obtain a CFS for the exportation of…
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…
A first revision of the formal policy on the implementation and enforcement of an exemption from registration for export only medical devices has been published1. Section 5(1) of the Medical Device Act 2012 (Act 737) states that no medical device shall…
In September 2018, the Therapeutic Goods Administration introduced a new process for issuing Certificates of Free Sale and Export Certificates1. This process sets out the eligibility criteria for applying for a Certificate of Free Sale or an Export Certificate, what…
On 12 October 2018, the Therapeutic Goods Administration’s summary of fees and charges was updated to include a change in the application fee for export only medical devices1. The revised document states that the application fee for inclusion in the…
