Provision No. 2096/2022 was published in the Official Gazette on 23 March 2022 to set out the Management System for Modifications and Authorisations of Medical Product Establishments (GEMHA)1. It will become effective 60 administrative working days after its publication, and…
From 1 September 2017, all virtual manufacturers (previously known as own brand labellers) must hold the full technical documentation for any product they place on the market under their name1. Previously, the UK Medicines and Healthcare products Regulatory Agency (MHRA)…
Guidance has been drafted on notifying the Food and Drug Administration (FDA) of a permanent discontinuance or interruption in manufacturing of a device1,2 under Section 506J of the Federal Food, Drug, and Cosmetic Act (FFD&C Act). The FFD&C Act requires…
Good Manufacturing Practice (GMP) certificates for medical devices and in vitro diagnostics are now valid for five years from the date of issue1. Renewal applications must be submitted within 120 days of the expiry date to extend the validity. GMP…
A total of 22 medical devices have been proposed for inclusion on a list of medical devices that are prohibited from contract manufacturing1: implantable cardiac pacemaker; implantable cardioverter defibrillator; implantable cardiac contractility regulator; implantable circulatory auxiliary equipment; sports injury soft…
The Ethiopian Food and Drug Authority (EFDA) has released a Guideline for Medical Devices Good Manufacturing Practice1. This guideline specifies requirements for current Good Manufacturing Practice (cGMP) during design and development, manufacture, storage, distribution, installation, servicing, and final decommissioning and…
The Regulations Amending Certain Regulations Concerning Drugs and Medical Devices (Shortages) were published on 1 September 20211. These new Regulations extend and modify certain measures already in place through two Interim Orders to help track, prevent and mitigate shortages of…
Updated essential safety and efficacy requirements applicable to health products, excluding in vitro diagnostic medical devices, came into force on 1 October 2021 through publication of Resolution RDC No. 546 of 30 August 20211. This Resolution transposes Mercosur Resolution/GMC/Res. No.…
Resolution RDC No. 554/2021, which was published on 31 August 2021, establishes the minimum requirements for the production of natural rubber latex male condoms1. These new requirements, which came into force on 1 October 2021, adopt Mercosur/GMC Resolution 10/08 and…
With effect from 1 October 2021, Resolution RDC No. 539 of 30 August 2021 establishes the minimum identity and quality requirements for single-use transfusion, gravitational infusion and infusion use equipment for use with an infusion pump1. Topics addressed include conformity…
Resolution RDC No. 544 of 30 August 20211 establishes the general and specific requirements and testing procedures for plastic bags for the collection, storage and transfer of human blood and its components, including requirements relating to use of polyvinyl chloride…
Resolution RDC No. 552 of 30 August 2021 establishes the conditions required for registration, manufacturing, quality control and user information for an intrauterine device (IUD) containing copper1. Chapter II, General Requirements, sets out the specifications for the IUD’s shape, dimensions,…
Resolution RDC No. 555, dated 30 August 20211, establishes the framework for the limulus amoebocyte lysate (LAL) reagent within the technical regulation on medical products (Resolution RDC No. 185/2001). This Resolution entered into force on 1 October 2021. An LAL…
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…
Comments are being accepted until 17 December 2021 on Technical Regulations for Mandatory Requirements for Medical and Laboratory Measurement Instruments1. These Regulations establish mandatory requirements for the following measuring instruments that are used in laboratories of all kinds, medical clinics,…
Chinese medical device market The Chinese medical device market is the fourth largest in the world, with a revenue of 800 billion RMB in 20201 and an annual growth rate of around 20%. Although the Chinese government strives for ‘Made in…
Guidance has been issued to set out the Food and Drug Administration’s (FDA’s) recommendations on testing to assess the safety and compatibility of medical devices in the magnetic resonance (MR) environment and the recommended format for magnetic resonance imaging (MRI)…
New administrative procedures for granting certification of Good Manufacturing Practices, and Good Distribution and/or Good Storage Practices have been published in Resolution of the Collegiate Board (RDC) No. 497/2021 and came into force on 1 June 20211. The purpose of…
In light of the COVID-19 pandemic, and the continuing need for personal protective equipment for medical and hospital staff in El Salvador, Salvadoran Technical Regulation RTS 11.03.01:20, Medical supplies. Face masks for medical use. Technical specifications and test methods will…
Due to an increase in administrative change requests combined with an overall rise in applications received, the Therapeutic Goods Administration (TGA) has announced that it will be prioritising assessments of Good Manufacturing Practice (GMP) Clearances over administrative changes1. Although the…
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…
Comments are being accepted until 20 May 2021 on proposed changes to the management of certain medical device activities1. The proposed changes would affect the procedures for managing renewals of Good Manufacturing Practice certificates, expansion of activities, and renewals of…
All companies that have submitted simple copies of Letters of Legal Representation and Certificates of Good Manufacturing Practice must now submit the original apostilled or consularised document or legalised photocopy within 60 business days of publication of Circular MSyD/AGEMED/CR/51/2021, which…
Guidelines have been published for the issuance of temporary authorisations for medical devices, for healthcare establishments, and for the temporary certification of Good Manufacturing Practices for devices that contribute to the control of the COVID-19 pandemic1. The Guidelines became effective…
Taiwan’s new Medical Devices Act1, which formally separates the regulation of medical devices from pharmaceuticals, is set to take effect on 1 May 2021. The Act defines medical devices as: ‘instruments, machines, apparatus, materials, software, reagents for in vitro…
The Regulations Governing the Inspection of the Medical Device Quality Management System and the Issuance of the Manufacturing License, which were proposed in June 20201, were promulgated on 2 February 2021 and will come into effect on 1 May 20212. …
Comments have been sought on a proposal to amend the Standards of Medical Device Good Manufacturing Practices (GMP)1. Two main changes are proposed. Firstly, for GMP audits that are subject to documentation review only, there are two additional documents that…
Supreme Decree No. 036-2020-SA1 modifies Supreme Decree No. 018-2020-SA, which sets out provisions for, inter alia, Certificates of Good Manufacturing Practice (GMP) used for the registration and importation of medical devices. A change has been made to Article 3.2 of…
Measures have been implemented to facilitate and expedite the production and delivery of equipment to hospitals treating patients with severe acute respiratory syndrome, such as that caused by COVID-19. In an effort to reduce demand for ventilators, the Brazilian Health…
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…
In response to the COVID-19 public health emergency, the Directorate General of Medicines, Supplies and Drugs (DIGEMID) has issued a few legislative documents to support access to critical products. The regulatory documents affecting medical devices are as follows1: Ministerial…
On 19 May 2020, the National Medical Products Administration published Guidelines for evaluating changes in raw materials of passive medical device products1. The purpose of these Guidelines is to provide systematic and instructive guidance on the risk analysis of raw…
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,…
Regulations Governing the Inspection of the Medical Device Quality Management System and the Issuance of the Manufacturing License1 have been proposed by the Department of Health in accordance with Article 22, paragraph 4 of the Medical Devices Act. An application…
Regulatory authority The Central Administration of Pharmaceutical Affairs (CAPA) within the Egyptian Drug Authority (EDA) is responsible for overseeing the regulation of medical devices in Egypt. CAPA has overall responsibility for the evaluation, classification, registration and licensing of locally produced…
A mandatory Mexican Official Standard PROY-NOM-241-SSA1-2018, Good Manufacturing Practices for medical devices, has been drafted and circulated for comment1. The purpose of the standard is to set out the minimum requirements for the design, development, manufacture, warehousing and distribution processes…
New guidance entitled Medical Devices Containing Materials Derived From Animal Sources (Except for In Vitro Diagnostic Devices) has updated a guidance of the same name from November 1998 on the use of animal-derived material in medical device manufacturing1,2. The guidance…
Final guidance has been published by the Food and Drug Administration (FDA) entitled Manufacturing Site Change Supplements: Content and Submissions; Guidance for Industry and Food and Drug Administration Staff1,2. The guidance explains what constitutes a manufacturing site change (including a…
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.…
Amendments have been made1 to Annex No. 01 (Glossary of Terms and Definitions) of the Regulation for the Registration, Control and Sanitary Vigilance of Pharmaceutical Products, Medical Devices and Sanitary Products, approved by Supreme Decree No 016-2011-SA. One of the…
In accordance with the statutory mandate of the 21st Century Cures Act, the Food and Drug Administration has published a proposed list of processes for single-entity and co-packaged combination products that can satisfy the current Good Manufacturing Practice (cGMP) requirements…
On 17 September 2018, Swissmedic will start to accept electronic orders for Export Certificates (Certificates of Free Sale, CFSs) and Manufacturing Certificates (MCs, attestations) for medical devices1. There will be a transitional period lasting until 19 October 2018, during which…
Introduction The regulatory requirements for market placement of medical devices in the Russian Federation are in a state of transition from the country’s domestic legislation to the rules of the Eurasian Economic Union (EEU). At present the two regulatory systems…
A draft partial amendment of the Regulation for Registration of Medical Devices (30 December 2004) has been prepared and circulated for public comment1. The main points of the amendment are as follows: With the provisions of Paragraph 3 of Article…
Guidance entitled Current Good Manufacturing Practice [cGMP] Requirements for Combination Products1 has been published to provide background information on combination products, an overview of the 2013 document on cGMP requirements for combination products2, and the role of the lead Center…
A number of amendments1 have been made to ANMAT Disposition No 7425/132, which concerns the requirement for manufacturers and importers of medical devices and in vitro diagnostics (IVDs) to adhere to Good Manufacturing Practices (GMP). These amendments have been introduced…
