Resolution RDC No. 550 of 30 August 20211 establishes the minimum identity and quality requirements for breast implants and the requirement of compliance certification of the product under the Brazilian Conformity Assessment System (SBAC). The Resolution came into force on…
The minimum identity and quality requirements for hypodermic needles and gingival needles have been established through Resolution RDC No. 540 of 30 August 2021, which came into force on 1 October 20211. Excluded from the scope of this Resolution are needles…
Resolution RDC No. 541 of 30 August 2021 establishes the minimum identity and quality requirements for single-use, sterile hypodermic syringes made of plastic and intended for fluid aspiration or fluid injection, performed manually or by syringe pump1. The scope of…
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,…
With effect from 1 October 2021, Resolution RDC No. 547 of 30 August 2021 has established the minimum identity and quality requirements for surgical gloves and gloves for non-surgical procedures of natural rubber, synthetic rubber, a mixture of natural and…
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…
Guidance has been released1 to assist in the integration of Unique Device Identification (UDI) and the implementation of UDI obligations as part of an organisation’s Quality Management System (QMS), as required by Article 10(9)(h) of Regulation (EU) 2017/745 on medical…
Since 30 May 2021, Quality in 510(k) Review Files are no longer being accepted by the Food and Drug Administration (FDA)1. Instead, companies should consider using the electronic Submission Template and Resource (eSTAR). The FDA launched its Quality in 510(k)…
Resolución Exenta No. 837 of 7 May 20211 is the reference document for the implementation of the Quality Assurance Program for equipment used in public or private nuclear medicine establishments in Chile. The document establishes the quality tests, periodicity, tolerance,…
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…
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…
Introduction In Europe, manufacturers are transitioning away from the long-established Medical Device Directive (MDD)/Active Implantable Medical Device Directive (AIMD Directive)/In Vitro Diagnostic Directive (IVD Directive) to the new but not yet fully supported Medical Device Regulation (MDR)1/IVD Regulation (IVDR)2. In…
From 1 January 2025, only ISO 13485 certificates issued by third-party certification bodies accredited by the Singapore Accreditation Council (SAC) will be accepted for medical device licence applications1. By the end of 2021, certification bodies should aim to achieve SAC…
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. …
A partial amendment of the Ministerial Order for the Standard of Manufacturing Control and Quality Control for Medical Devices and In vitro Diagnostic Pharmaceutical Products (Ministerial Order No. 169 of 2004, the QMS Ministerial Order) has been proposed1. The amendment would…
In light of the COVID-19 pandemic and the difficulty of carrying out overseas inspections, Argentina will accept1 ISO 13485 or Medical Device Single Audit Program (MDSAP) certificates instead of certificates issued by the National Administration of Drugs, Food, and Medical…
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…
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…
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…
Introduction The agency in charge of regulating medical devices in Argentina is the National Administration of Drugs, Food Products and Medical Technology (ANMAT). ANMAT Disposition No 1285/2004 (restatement of Disposition 2318/2002) defines a medical device as any equipment, device, material,…
Pursuant to Article 22 of the Medical Device Act1, the Medical Device Quality Management System Regulations have been drafted and a 24-page English version has been circulated for public comment2. Taiwan’s standards relating to facilities, equipment, organisation and personnel, production,…
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…
Five new guidance documents have been published recently by the Saudi Food and Drug Authority (SFDA): MDS-G34, Guidance on Requirements for Unique Device Identification (UDI) for Medical Devices (11 December 2019)1 The purpose of this guidance is to specify the…
The Russian Federation has approved requirements for organising and conducting internal quality control and safety monitoring of medical activities in medical organisations through the publication of Order No 381n, dated 7 June 2019, which was registered by the Ministry of…
The Ministry of Food and Drug Safety of the Republic of Korea has proposed amendments1 to the Medical Devices Act to address certain limitations identified during operation of the Act. The proposed revisions are as follows: Clarification of the…
Introduction The agency in charge of regulating medical devices in Argentina is the National Administration of Drugs, Food Products and Medical Technology (ANMAT). ANMAT Disposition No 1285/2004 defines a medical device as any equipment, device, material, product or system of…
In June 2019, the Therapeutic Goods Administration (TGA) released new guidance1 on the Therapeutic Goods (Conformity Assessment Standard for Quality Management Systems) Order 20192. The 2019 Order specifies relevant conformity assessment standards for medical device Quality Management Systems (QMSs), and…
Public consultation is being held until 31 August 2019 on a draft Guideline on the quality requirements for drug-device combinations1 developed by the European Medicines Agency (EMA). The guideline provides advice on the documentation expected for drug-device combinations (DDCs) in…
A number of new guidance documents pertaining to medical devices have been published1 by the Saudi Food and Drug Authority: MDS-G35, Guidance to Implement a Medical Devices Standard ‘Quality Management System’ Regulatory Requirement (ISO 13485:2016) (15 April 2019); MDS-G34,…
The Department for Pharmaceuticals, in association with the Bureau of Indian Standards (BIS), has published six draft Quality Control Orders and invited comments on them from stakeholders1: Medical Devices – Medical Electrical Equipment (Quality Control) Order, 2018; Medical Devices…
On 1 March 2019, the Regulations Amending the Medical Devices Regulations (Updating ISO Standard)1 amended the Medical Devices Regulations by replacing ‘13485:03’ with ‘13485:16’ in paragraphs 32(2)(f), 32(3)(j) and 32(4)(p). The Medical Devices Regulations require manufacturers to submit a Quality Management…
Two new final guidance documents have been published1 by the Saudi Food and Drug Authority (SFDA): MDS-G20, Guidance on Requirements for Clinical Investigations of Medical Devices; and MDS-G30, Guidance on Patient-Matched Medical Devices Using 3D Printers. In addition, eight new draft…
An amendment has been proposed to the Standards of Medical Device Good Manufacturing Practices (GMP) in the Republic of Korea1. If finalised, the amendment would harmonise Korea’s requirements with international practices by adopting ISO 13485: 2016. It would improve the…
A Guidance Document for Medical Devices has been drafted1 by the Indian Pharmacopoeia Commission (IPC) to act as a consolidated reference document describing the standards, regulatory and other requirements for medical devices in India. Topics addressed by the draft guidance…
On 9 May 2018, the US federal government published its spring 2018 Unified Agenda of Federal Regulatory and Deregulatory Actions1, which provides federal agencies with the opportunity to update the public on the government’s regulatory priorities. One of the identified…
Introduction The Food and Drug Administration (FDA) Commissioner, Dr Scott Gottlieb, authored a blog post on 9 May 2018 discussing the Spring 2018 Unified Agenda of Federal Regulatory and Deregulatory Actions1, which provides federal agencies with the opportunity to update the American…
Introduction The world of laboratory testing is becoming more complicated and more complex, with genetic testing at the forefront. At the same time, global economies have changed and health insurance is now radically different with the passing of the Affordable…
Introduction Medical devices distributed in Japan are subject to the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics (PMD Act), which has been enforced since November 2014…
Technical experts from the International Organization for Standardization Technical Committee ISO/TC 210 have developed a handbook1 containing practical guidance and an accurate interpretation of the requirements specified in ISO 13485:2016. The handbook’s guidance applies to the various stages of a…
The Food and Drug Administration has launched a voluntary pilot programme entitled Premarket Approval Application Critical to Quality (PMA CtQ)1. This pilot programme began on 29 September 2017 and will end on 31 December 2018; due to resource constraints, it is limited to…
Regulatory authority Health Canada is the Federal department responsible for reviewing medical devices and in vitro diagnostic devices (IVD devices) to assess their safety, effectiveness and quality before being authorised for sale in Canada. Within Health Canada, the Health Products…
The Center for Devices and Radiological Health (CDRH) is running a Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot Program (CfQ Pilot Program) from 2 January 2018 until 28 December 20181. This voluntary pilot programme has been designed to:…
Updated lists of standards harmonised under the Active Implantable Medical Device Directive (90/385/EEC), the Medical Device Directive (93/42/EEC) and the In Vitro Diagnostic Directive (98/79/EC) have been cited in the Official Journal in the form of three Commission Communications1-3. Of…
Brazil is a large country with extensive and constantly expanding medical device regulations. This report explores the changes that are likely to have the greatest impact on companies’ regulatory strategies during 2018. Firstly, it sets out the official regulatory agenda…
