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Malaysia Device Authority of Malaysia (MDA) just recently published the medical device guidance document on the requirements for labelling of medical devices in Malaysia. For the full guidance, please refer to the following for further information: http://www.mdb.gov.my/mdb/index.php?option=com_content&task=view&id=295

A recent announcement by the Therapeutic Goods Administration Australia (TGA) provides information for current users of ISO 13485:2003 who are considering transitioning to ISO 13485:2016, and other interested parties. This announcement comes on the heels of the publication of a new revision to ISO 13485, the medical device quality management systems (QMS) standard for regulatory purposes, which replaces the previous version from 2003 by the International Organization for Standardization (ISO). It is already confirmed that the ISO 13485:2003 and ISO 13485:2016 will coexist for the next three years so as to allow users of the standard to transition to the new revised standard. It is recommended that the users of ISO 13485:2003 work with the TGA, or their EU Notified Body, CMDCAS Registrar, MDSAP Auditing Organisation, or other recognised certification body, to schedule an upgrade audit at a convenient time within the transition period. To add on, ISO 13485:2003 is now formally recognised in Australia under the Conformity Assessment Standards Order (Standard for Quality Management Systems and Quality Assurance Techniques) 2008, made for the purposes of section 41DC of the Therapeutic Goods Act 1989, as a standard for the manufacture of all kinds of medical devices that require a quality management system for conformity assessment. In the interim, the TGA will continue to recognise audits based on ISO13485:2003 for the period indicated on the associated certificate, however these certificates must expire no later than 1 January 2019 (aligning closely with the end of the ISO transition period on 1 March 2019). Additionally, audits based on ISO13485:2003 will continue to be conducted by the TGA until 1 January 2019 unless the manufacturer elects to use the newer standard. Audits performed by the TGA under the EU-AU Mutual Recognition Agreement (MRA), as a Conformity Assessment Body, will be carried out against EN ISO13485:2012 or EN ISO13485:2016 as required by the EU Commission.

The precise impact of a vote for Brexit is currently still uncertain. It would fundamentally change the nature of the UK’s relationship with the rest of the EU and the world and may also result in significant changes for those doing business in the UK. However, these changes may be particularly relevant to the pharmaceutical and medical device industries. Brexit would also bring into question the large amounts of UK law based on EU rules. In each area, the UK would need to decide whether to continue to follow the EU lead or go its own way and may risk damaging trade with the EU which is currently based on the adoption of consistent EU wide standards. Moreover, even if the UK were to decide to continue to follow the EU lead this may, in some circumstances, be insufficient to permit the continued marketing of UK products in the EU. As an example, the pharmaceutical and medical device sectors are among the most highly regulated in the EU. Currently, the demonstration of compliance with related legal obligations permits UK manufacturers to market their products throughout the EU. Brexit would mean that UK manufacturers would no longer be bound by related EU legal obligations. Also, the laws governing pharmaceutical products and medical devices following Brexit would be UK-specific laws, rather than current or future EU laws. Consequently, a voluntary undertaking by UK manufacturers following Brexit to continue to comply with EU obligations may be considered insufficient to support a claim of compliance with related legal obligations. The right for medical device manufacturers to affix a CE mark to their products is based on demonstration of compliance with the obligations laid down in the EU medical device directives and related guidance documents that are currently the basis of related UK law. Brexit would mean that UK medical device manufacturers would no longer be permitted to claim automatic entitlement to market medical devices throughout the EU on the grounds that they have conducted a conformity assessment on the basis of EU device rules and affixed the CE mark to their devices. Like all other non-EU manufacturers, in order to continue to market their products within the EU, UK manufacturers would be required to appoint a European Authorised Representative established within an EU Member State. In addition, UK notified bodies would no longer be entitled to conduct a conformity assessment on the basis of the Directives. As a result, manufacturers working with UK notified bodies in relation to the conformity assessment of their medical devices would be required to appoint a new notified body established in an EU Member State. This is likely to lead to a new conformity assessment to permit the continued marketing of their medical devices in the EU.

According to Health Canada, the Canadian medical device market regulator is planning to extend the deadline for commercially reprocessed devices to obtain Medical Device and Medical Device Establishment Licenses so as to meet market authorization requirements. For companies that engages in reprocessing and distribution of single-use devices regardless in Canada or abroad, the deadline to meet the same Health Canada licensing and registration requirements currently in place for new devices according to the Canadian Medical Devices Regulations (CMDR) is September 1, 2017. There are no plans in extending these requirements to devices that are reprocessed on site at hospitals thus far as these products continues to be overseen by provincial and territorial authorities. Among the CMDR requirements reprocessed medical devices will need to meet in Canada are: Obtaining a Medical Device License (MDL) or Medical Device Establishment License (MDEL) •Quality management system compliance •Device labeling •Investigations and complaint handling •Conducting recalls and incident reporting Regarding labeling, reprocessed device labels should clearly identify reprocessors as their manufacturers as well as provide instructions for safe reuse. Any single-use symbols should also be removed from reprocessed device labels. The initial deadline for reprocessed devices was originally set for September 1,2016, but the date was extended to 2017 as regulators wanted to grant more time for manufacturers and reprocessors to meet CMDR requirements.

Health Canada is preparing the process of adopting the Medical Device Single Audit Program (MDSAP) in place of the current Canadian Medical Devices Conformity Assessment System (CMDCAS) which is slated to commence in 2017. The program will allow device manufacturers to undergo a single audit to satisfy the quality requirements of five participating nations (the US, Australia, Brazil, Canada, and Japan), instead of facing many inspections from different regulators. As Health Canada is keen to fully integrate MDSAP into its regulatory framework by January 2019, it has warned to suspend all medical device licenses that are not supported by a MDSAP certificate by the end of the transition period. CMDCAS registrars have been given the opportunity to apply to be recognized as MDSAP auditing organizations so as to facilitate the transition process. To date, only five of the 13 CMDCAS registrars have been formally recognized to perform MDSAP audits.

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The consolidated final draft of the new Medical Device Regulation (MDR) has recently been published. The new regulation shall replace the current medical device directives, namely Medical Device Directive 93/42/EEC and Active Implantable Medical Devices 90/385/EEC. The IVD Directive 98/79/EC will be replaced by its own new regulation, named the In Vitro Diagnostic Medical Devices Regulation, IVDR. This new regulation on medical devices will bring forth many change for medical device manufacturers. Apart from changes to the classification of some medical devices, the definition of medical devices is also expanded. The definition of medical devices is expanded to include, amongst others, devices with purposes related to prediction and prognosis of diseases. This change might have an impact on quantification products and services in the field of health-related parameters which could now fall within the scope of the new Regulations. For certain high-risk devices, such as implants, products may now undergo an additional check by experts before they are placed on the market. The conformity assessment procedure for these devices can include the intervention of expert panels, designated by the European Commission. Notified bodies may seek advice from an expert panel on applications for conformity assessment for such devices. The notified body shall give due consideration to the views expressed by the expert panel. Although the final draft is expected to be adopted by the end of this year, the new law will come into effect three years after publication in the EU Official Journal.

Israeli investment company Trendlines Ltd. has announced that it is founding a medical technology incubator in Singapore. Trendlines operates a medical technology incubator in Israel and a fund for investing in mature companies from the incubator, is active in R&D for international corporations, and is a partner in a fund with international company Bayer for agtech investments. The incubator is based on ideas originating mainly with universities, government research institutes, and other institutions of higher learning. Singapore resident Eric Loh, former senior VP at Singapore European radiology company Biosensors International, listed on the Singapore stock exchange with a $1 billion market cap, will manage the incubator.

Health Sciences Authority of Singapore(HSA) recently updated the Guidance documents with clarification on grouping (GN-12-1-R2 and GN-12-2-R2) and the class A exemption notification (GN-22-6.2). For the Special Access route under GN 26 and GN 27 SAR for qualified practitioner and PHMC, the applicant company now requires quality management system in place eg. GDPMD certification.

Health Science Authority (HSA) will be rolling out a new Singapore Standard(SS) as early as November 2016. This new guidance will be replacing the current Technical Specification(TS-01) albeit manufacturers and industry participants alike will be given adequate transition period before the official change. HSA also confirmed that the TS will remain live until after the whole industry has transited over to SS. This new SS provides detailed specification for Good distribution practice for medical devices(GDPMDS) in Singapore. ARQon will provide updates once the official announcement is announced.

Closer to home, the Malaysian government recently announced the exemption of all types of Class A (lowest-risk) devices from conformity assessment requirements hence making it easier for companies to bring such products to the market. This is great news to manufacturers who would like to test the market in Malaysia.

Meanwhile in Philippines, Food and Drug Administration Philippines (FDA) has come out with a Draft for New Schedule of Fees and Charges of FDA on Licensing, Registration and other Certification. The rationale for the revision of fees is because of the income retention and withdrawal of subsidy by the Philippines government to FDA. Due to this change, fees and charges will be the only source of funding support for operations and capital expenditures thus making it a need to implement the adjustments.