Towards the end of June 2018, a draft Amendment of the Medical Device Supervision and Administration Regulations was circulated for public comment1. These proposed changes are quite extensive: 12 articles are proposed for addition, two for deletion and 39 for…
In order to expedite the importation of health products into Brazil, new rules have been published that create four different import channels that take into account a product’s type and its associated risk criteria1. The green channel is a simplified…
Introduction On 5 May 2017, the new Regulation 2017/745 on medical devices (MDR) was enacted, with a full implementation date across the 28 European Union (EU) Member States set for 26 May 20201. On this day, the Regulation will replace…
The requirements for obtaining an importation licence and a clearance for a non-medical in vitro diagnostic (IVD) have been clarified in a new guidance document (MDS-G16) from the Saudi Food and Drug Authority (SFDA)1. The guidance applies to importers of…
Guidance on the importation requirements for personal use and custom-made medical devices (MDS-G15) has been published by the Saudi Food and Drug Authority (SFDA)1. This guidance specifies the requirements and procedures for obtaining an importation licence and shipment clearance for…
Specific guidance has been provided by the Saudi Food and Drug Authority (SFDA) on obtaining an importation licence and shipment clearance for medical devices in national emergency situations (e.g. a natural disaster, criminal or terrorist acts, war)1. In national emergency…
China has reduced the import tariffs on 201 technology products, including around 30 medical device types1, under an amendment to the World Trade Organisation’s Information Technology Agreement, which was ratified by China in September 2016. Affected medical devices include electrodiagnostic…
Specific data must be submitted through a new electronic system called the Automated Commercial Environment (ACE) when a product regulated by the Food and Drug Administration (FDA) is offered for import into the USA. The ACE system is operated by…
All imported medical devices, food supplements, medical cosmetics, herbal products and other allied healthcare borderline products that are controlled by the Pharmacy and Poisons Board (PPB) must comply with the Pre-Export Verification of Conformity (PVoC) to Standards programme implemented by…
Instancias reguladoras El Ministerio de Salud (MSP) es el ente rector de la política pública de salud. La Agencia Nacional de Regulación Control y Vigilancia Sanitaria (ARCSA) realiza el control de registro sanitario de los dispositivos médicos y otros productos.…
Regulatory authority The Ministry of Health (MSP) is the governing body responsible for public health policy. The National Agency for the Regulation and Sanitary Surveillance and Control (ARCSA) controls the sanitary registration of medical devices, amongst other products. In addition,…
Introduction India is one of the largest medical device markets globally and therefore needs a robust system for the regulation of medical devices. At present only a few medical devices in India are regulated as drugs under the Drugs and…
Guidance has been issued 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. No medical devices may be…
In order to streamline the process for obtaining customs clearance of radiation devices and to ensure the traceability of those devices from importation through to the end user, new guidelines have been published in FDA Circular No 2017-0131. The Circular…
Clarification has been provided1 to importers and India’s port offices following reports of imported consignments of medical devices and in vitro diagnostics (IVDs) being unnecessarily detained at their point of entry into the country. In cases of slight discrepancy between…
Resolution RDC No 203 of 26 December 2017 sets out the criteria and procedures for the importation, on an exceptional basis, of products that are subject to sanitary surveillance but are not registered with the National Health Surveillance Agency (ANVISA)1.…
The procedures for importing products subject to sanitary surveillance, which includes medical devices, into Brazil have been simplified by Resolution RDC No 208/20181. Probably the most significant change is that imported devices will no longer have to undergo inspections at…
Regulatory authority Singapore’s healthcare regulatory framework consists primarily of: the regulator, which is the Ministry of Health along with its statutory boards; and the regulated, which are the public and private healthcare providers. Medical devices are regulated under the Health…
Regulatory authority After its independence in 1947, the Pakistan Government adopted India’s Drugs and Cosmetics Act, 1940. However, owing to the Act’s limitations, the Government of Pakistan enacted a completely new Drugs Act in 1976, which was administered by the Drug…
The Saudi Food and Drug Authority has finalised and published eight new guidance documents relating to medical devices1: MDS-G7, Guidance on Medical Devices Bundling Criteria; MDS-G12, Guidance on Importation Requirements for Chemicals Used in Medical Devices Applications; MDS-G13, Guidance for…
Guidance has been published that specifies the requirements for notification of importation and/or supply of unregistered medical devices intended solely for the purpose of demonstration for marketing or for the purpose of education1. The guidance applies to all applicants who…
