Technical Info for Glass Syringes: Supplement to ISO 11040-4: 

It provides important technical information that manufacturers of glass syringes intended to deliver drugs or biological products need to consider. This guidance is particularly pertinent for manufacturers who need to demonstrate conformity with ISO 11040-4 and ensure proper connectivity with other medical devices.

EUROPE

Europe and EUDAMED

The EU Commission provides extensive information on the European Regulations 2017/745 (MDR) and 2017/746 (IVDR), current topics in the European medical device sector, and the European database for medical devices, EUDAMED. A workshop on July 10, 2024, discussed priorities and challenges in implementing these regulations to ensure a secure supply of innovative medical products. The workshop results will guide future collaboration with the European Commission, emphasizing the importance of swift and effective regulation implementation.

Important Points

1. Common Goal: The primary aim is to ensure patient access to safe and innovative medical products through the successful implementation of MDR and IVDR regulations.
2. EUDAMED Platform: EUDAMED is designed as a central platform for data exchange on medical devices in Europe, consisting of six modules, though not all are fully operational yet.
3. Workshop Outcomes: Authorities and the European Commission identified priorities and challenges, with the results forming the basis for further regulatory work and an open letter urging the EU Commission to prioritize the implementation of medical device regulations.

Learn more about EU Medical Device Registration.

CANADA

Updates to Medical Device Standards and Draft Guidance

The consultation on updates to Health Canada's list of recognized standards for medical devices and related guidance is open from July 25 to September 23, 2024.

Important Points

1. Participation: Stakeholders can provide input by emailing [email protected].
2. Focus Groups: The consultation targets medical device manufacturers, regulatory affairs representatives, and healthcare professionals.
3. Key Questions: Feedback is sought on the clarity of the list and guidance, any missing concepts, and suggestions for additions, removals, or updates to the list.

GMP Inspections and Extended TGA GMP Certificate Validity

Starting July 1, 2024, Health Canada will implement temporary surveillance inspections for domestic and overseas manufacturers of medicines, Active Pharmaceutical Ingredients (APIs), biologicals, and blood products. These inspections will be full-scope but shorter in duration, reducing typical inspection times by about 50%. The initiative aims to address the backlog of GMP inspections caused by the COVID-19 pandemic. Additionally, the validity of TGA-issued GMP certificates for domestic sites will be extended from three to four years if no re-inspection has occurred in the past three years.

Important Points

1. Introduction of Surveillance Inspections: These are full-scope but reduced-duration inspections covering all aspects of the manufacturer's Pharmaceutical Quality System (PQS) and operations, potentially reducing inspection time by 50%.
2. Eligibility Criteria: Only manufacturers with a good or satisfactory compliance rating (A1 or A2) from their previous TGA inspection are eligible for surveillance inspections. Sites with lower ratings, ongoing compliance issues, or those requiring initial or variation inspections are ineligible.
3. Extended Validity of GMP Certificates: TGA-issued GMP certificates for licensed sites that have not had a re-inspection in the last three years will have their validity extended from three to four years.

Health Canada's Proposed Changes to Medical Device Standards

Health Canada has updated the list of recognized standards for medical devices and the guidance on using standards to support compliance with the Medical Device Regulations. The updates include a new method of version recognition, six new standards, twelve updated standards, and the removal of fourteen standards. The updated guidance document clarifies the application of standards by manufacturers and the new version recognition method.

Important Points

1. New Method of Version Recognition: Standards are now listed without specific years and editions to simplify version recognition.
2. Addition and Removal of Standards: Six new standards have been added, twelve updated standards now include notes, and fourteen standards have been removed.
3. Consultation Period: Feedback is sought from stakeholders on the clarity of the list and guidance, the changes in standards, and any missing concepts, with a 60-day consultation period from July 25 to September 23, 2024.

Learn more about CDMR Canada Medical Device Registration & Approval.

CHINA

Notice on Issuing On-site Inspection Guidelines for Medical Device Quality Management

The newly revised "Medical Device Business Quality Management Standards" will be effective from July 1, 2024. To guide and standardize on-site inspections, the National Medical Products Administration has issued the "Guiding Principles for On-site Inspection of Medical Device Business Quality Management Standards." These principles will be used for various types of inspections, including business license verifications, renewals, and routine supervision.

Important Points

1. Implementation Date: The revised standards and the accompanying guiding principles will be effective from July 1, 2024.
2. Inspection Criteria and Results: The inspection results will be categorized as “passed inspection,” “rectification within a time limit,” or “failed inspection,” based on compliance with key and general items. Specific thresholds determine these categories.
3. Rectification Process: Companies given a "rectification within a time limit" must submit a rectification report within 30 working days. Failure to meet requirements after re-inspection can lead to a denial of the business license.

Learn more about China Medical Device Registration & Approval.

Regulatory enrolment process (REP)

The Regulatory Enrolment Process (REP) streamlines the filing and processing of regulatory information for companies, dossiers, products, regulatory activities, and transactions through structured web-based templates. These templates replace existing Health Canada forms and facilitate a common submission intake across various product lines, enabling Health Canada to receive a wider range of regulatory information via the Common Electronic Submission Gateway (CESG) and automate transaction imports.

Important Points

1. Streamlined Submission Process: REP uses web-based templates to replace traditional forms, promoting a unified submission intake across different product lines.
2. Automation and Efficiency: The process allows Health Canada to automate the import of regulatory transactions into its repositories, enhancing efficiency.
3. Implementation Timeline: REP is mandatory for Human Use Drugs, Veterinary Drugs, and Disinfectants, with specific implementation dates for Medical Devices and other categories.

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