Medical Devices – USA, Europe, Asia Regulatory News – Nov 2022

Asia

Philippines FDA Publishes Circular on The Abridged Processing of Medical Devices Registration with Approval by The NRA of Any ASEAN Member Country

Philippines FDA issues Circular No. 2022-008 on 27th September 2022, aims to provide guidelines on the abridged processing of applications for registration of medical devices with product approval issued by the NRA of any ASEAN member country under the AMDD-CSDT requirements. This Circular shall apply to Class B, C and D medical devices that are covered under AO No. 2018-0002, with product approval issued by the NRA of any ASEAN member country under the AMDD-CSDT requirements, and which are to be imported, distributed and sold in the Philippines. This issuance shall not cover medical devices with issued Certificate of Product Registration (CPR) based on abridged approval in other countries outside the ASEAN. Furthermore, in consonance with AO No. 2018-0002, this Circular shall not cover in vitro diagnostic and refurbished medical devices.

HSA Guidance on Medical Device Advertisements and Sales Promotion: Overview

The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to the regulatory requirements for medical device advertisements and sales promotion. The document is intended to provide additional clarifications regarding the existing regulatory requirements, as well as recommendations to be taken into consideration when placing medical devices on the market and conducting marketing campaigns associated thereto. The authority also mentions that provisions of the guidance are non-binding in their legal nature, are not intended to introduce new rules or impose new obligations, and could be subject to changes, should such changes be reasonably necessary to reflect corresponding changes to the underlying regulations. The current document represents the second revision of the guidance issued by the HSA.

Europe

Guidance on EAR: obligations and responsibilities under the Regulations

In October 2022, the Medical Device Coordination Group (MDCG) published a new Guidance on obligations and responsibilities of the Authorised Representative. According to the Regulations on medical devices (MDR) and in vitro diagnostic medical devices (IVDR), when the manufacturer is not established in the EU, they must appoint a European Authorised Representative (EAR).

Specifically, the new MDCG Guidance addresses several points:

• Definitions
• Designation, mandate, termination of the mandate
• Registration and verification obligations
• Minimum tasks and responsibilities
• Liability
• Change of EAR
• Person Responsible for Regulatory Compliance (PRRC)

Issue of export certificates (Free Sales Certificates) for medical devices

Export certificates (Free Sales Certificates, FSC) are issued solely for products that are defined as medical devices under the terms of the Swiss legislation and for which a certificate of conformity is available, making them marketable in Switzerland. Swissmedic does not issue FSCs for veterinary medical devices or products that are defined as medical devices only in the country of destination, e.g. toothbrushes, instruments for dental laboratories, general laboratory equipment etc.  To order a Free Sales Certificate, please complete the electronic order form and provide all the corresponding documentation (e.g. EC certificate, declaration of conformity, product list in compliance with the requirements of our information sheet, etc.). All orders are submitted electronically with our constantly updated order form.

MDCG Joint Implementation plan on IVDR

The Medical Device Coordination Group (MDCG) released a new update to its joint plan on the preparedness and implementation of the In Vitro Diagnostic Regulation (IVDR). Despite the progress made – as explained in the last release of the Plan, the transition from the IVD Directive presents a significant challenge to stakeholders.

Committee for Advanced Therapies (CAT)

Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on Advanced Therapy Medicinal Products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 hereafter this Regulation lays down specific rules concerning the authorisation, supervision and pharmacovigilance of Advanced Therapy Medicinal Products and set up a Committee for Advanced Therapies (CAT or the Committee). Since the CAT is part of the European Medicines Agency, the Integrated Quality Management System, endorsed by the Agency Management Board on 11 March 2004, applies to this Committee; Having regard to Article 61(8) of Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for authorization and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency.

USA

Inspection Readiness: Ensuring Access to Contracted Archives and Documenting Drafts

Companies need to know how to access their archives – day or night – when using a third party for document storage and preparing for an FDA inspection, an FDA inspections expert advised at the WCG FDA news Annual FDA Inspections Summit in Washington, D.C., Nov. 16-18.

AI Tool Detects More than 80 Percent of Liver Cancers in New Study

John Hopkins Kimmel Cancer Center in Baltimore, Md., used artificial intelligence (AI) blood test technology to detect more than 80 percent of liver cancers in current liver cancer and at-risk patients. Researchers used the AI tool to assess 724 individuals from the U.S., EU or Hong Kong with hepatocellular carcinoma (HCC) or who were at average or high-risk for HCC. The blood test uses technology that detects cell-free DNA – fragments from DNA cancer cells that are shed into the bloodstream – to identify abnormal patterns.

Large-Scale Trial Shows Lunit Breast Cancer AI More Accurate than Radiologist Reviews

Lunit’s study of 55,579 mammograms showed an increased cancer detection rate and a lower patient recall rate using the company’s Insight MMG breast cancer artificial (AI) solution than a team of two radiologists, the South Korea-headquartered company reported.

Inspection Readiness: Tips for Handling Original Documents and Tracking Transfers

A comprehensive readiness plan for an FDA inspection includes thorough knowledge of your document archiving and transfer procedures, according to an FDA inspections expert speaking at the WCG FDA news Annual FDA Inspections Summit in Washington, D.C., Nov. 16-18. Walking attendees through his list of 10 questions to consider when preparing for an FDA inspection, David L. Chesney, principal of DL Chesney Consulting, spoke about the problem of having multiple originals. Make sure written procedures define versions, such as draft, final and original, he said, adding that final versions should be reconciled with originals and any removals need to be documented. Another question for inspection readiness is whether or not manufacturers have written requirements for in-house, remote or contracted employees and third-party vendors to transfer materials into the archives.

Designing Secure Medical Devices

Cybersecurity relates closely to both design controls and risk management in the medical device arena. So, any efforts to address cybersecurity must be incorporated into existing design and development planning, as well as overall risk management practices. That means that companies cannot simply stick an authentication algorithm or other Band-Aid on their connected device and be in compliance with regulations.

Industry seeks clarity, ICH Q9 alignment in FDA’s device production software guidance

Comments in response to the US Food and Drug Administration (FDA)’s draft guidance on software assurance for computer and data processing systems associated with medical device production have asked the agency to align some of the language in the document with the recent International Council for Harmonisation’s (ICH) Q9 guidance, exclude system lifecycle tools from the guidance and include information on cybersecurity. The draft guidance details a risk-based approach to “establish confidence in the automation used for production or quality systems, and identify where additional rigor may be appropriate” as well as steps for validating the software and its appropriate use. When implemented, FDA said the framework will help meet the requirements of 21 CFR 820.70(i), which dictates the maintenance schedule requirements of medical equipment.

Ophthalmic Devices Panel Recommends Eye Cups, Droptainers be Class I

The FDA’s Ophthalmic Devices Panel met Thursday and reached consensus that unfilled/empty eye cup and “Droptainers” ophthalmic devices — currently unclassified — should be considered Class I with general controls, as recommended by the FDA.

MDUFA Fees to Fund TAP Pilot and Speed Device Development

Sponsors of medical devices will see increased user fees under the recently reauthorized Medical Device User Fee Amendments (MDUFA) V, but they can also look forward to more rapid submissions and approvals under a new user fee funded pilot program, according to one Washington D.C.-based regulatory attorney.

FDA Pushes Back Comment Period on IRB, Informed Consent Rules

In response to requests for a later deadline, the FDA has granted more time to comment on a pair of long-awaited proposed rules on institutional review board (IRB) reviews and informed consent requirements for clinical trials, pushing back the deadline until Dec. 28.

South Africa

Guideline on how to lodge a complaint on medicines and medical devices

The guideline outlines the process to follow, and the information required when lodging a complaint on medicine and medical devices. The lodging of complaints initiates and facilitates the investigation process by SAHPRA. This guideline covers all types of complaints relating to the quality, safety and/or efficacy and advertising of medicines and medical devices. Adverse reactions resulting from the use of medicine are excluded from this guideline and should be reported to the Vigilance Unit at SAHPRA.