Regulatory Affairs Journals
DEVICES

With the increasing importance and development of Medical Devices and in vitro Diagnostics, RAJ Devices was established as a sister publication to RAJ, in 1993.

Contents for May 2001:

• Features
• Worldwide Update Headlines
• Reference

Guest Editorial on Healthcare Technology Assessment
Electronic Records & Signatures
Third-Party Review
IEC 60601-1
The Lifetime of a Device

Australia
Biological origin devices: proposed regulatory changes
Clinical trials: changes to the regulation finalised
Crisis management and tamper-evident packaging: new guidelines available
Dental materials: TGO No 67
Disinfectants: draft guidance on evaluation to be amended
Electronic applications: changes to proposed implementation date
Fees for 'safety evaluation': applicable devices
Gene technology: comments requested on draft implementing Regulations
GMP codes: current status
Medical device regulations: highlights of the Amendment Bill
Plasticised PVC blood bags: TGO No 68
TDEC meeting highlights
Trans-Tasman Authority: under consideration by Australia and New Zealand
TSEs:

• Expert Committee established
• TGA approach to minimising risk of exposure

Brazil
Reused, recycled and refurbished devices: new regulation finalised
VAT and import duties

Bulgaria
Fast-track regulatory procedure: applies to CE-marked medical devices

Canada
Cost recovery:

• document published by TPP
• evaluation of cost recovery initiative

Fees: electronic forms available
Guidance documents posted on the Internet
Health Canada:

• performance report for 1999�2000
• restructuring of the TPP

Healthcare technology assessments: industry view
Licensed medical devices: status checks recommended
MRA: EU/Canada
Patient lifts involved in incidents: addendum to Medical Device Alert 109

Charts
EU legislation directly affecting medical devices
Meetings of regulatory importance
Organisation chart: Czech Republic's State Institute for Drug Control (S�KL)
Standards update

Cuba
Regulatory programme: development strategy

Czech Republic
Organisation chart for S�KL

Editorials/Features
Canadian industry's view on healthcare technology assessments
Electromedical device standard
Electronic records and signatures in the USA
Healthcare technology assessments: Canadian industry view
IEC 60601-1
Lifetime of a device
Third party review under EC and US law

EU
Animal tissues: proposed Commission Decision
EEA Agreement: Amendment to Annex II
EEE Directive: Working Paper circulated for comment
Electrical and electronic waste: current status of Directives
Electronic signatures: common framework; amended proposal for Directive
Environmental issues: Integrated Product Policy
EU expansion: Treaty of Nice published
General Product Safety Directive: amended proposal and Common Position
Legislation directly affecting medical devices
Lifetime of a device
MRAs:

• Canada/EU
• Japan/EU
• USA/EU

Nomenclature: GMDN finalised; Maintenance Agency to be appointed
Parliamentary questions published in Official Journal
Risk management: EN ISO 14971 available
Third party review under EC and US law
TSEs: medical devices unaffected by Common Position
Vigilance: MEDDEV 2.12/1 revision 4, draft 2

France
AFSSaPS website charter
Animal origin products: ban on dura mater replacements
Code of Public Health: reorganisation
Huriet Bill: proposed premarket approval withdrawn
IVD Directive: transposition text published
Mammography: non-compliant products banned
Reimbursement conditions amended

Germany
Ethics Committee: new addition
Health technology assessment bodies: BVMed demands more rights for industry
MPG: second amendment
Notified Bodies: accreditation revoked

Greece
Barriers to trade: reimbursement of orthopaedic medical devices

Hungary
NB designation: Decree now adopted

International
Adverse event reporting
Electromedical device standard IEC 60601-1
MRAs:

• Canada/EU
• Japan/EU
• USA/EU

ISO: new President appointed
Trans-Tasman Authority: under consideration by New Zealand and Australia

Italy
Board of Health: restructuring announced

Japan
MRA: EU/Japan

Korea
Health and Welfare Minister: new appointment

New Zealand
Adrenaline injection kits: MoH issues warning
Trans-Tasman Authority: under consideration by New Zealand and Australia

Slovak Republic
Adverse incident reporting: movements towards harmonisation with EU

Spain
Catgut sutures: immediate withdrawal from market
Pricing: dual labelling requirements

Sweden
Blood and plasma: control of donations and transfusions
SOS:

• new Director appointed
• transfer of responsibilities to MPA

UK
Adverse incidents:

• electronic reporting using new website
• overview of 2000

Catgut sutures: cessation of supply
Coronary stents: vigilance guidance issued
MDA:

• Corporate Plan 2000�2005
• safety notices posted on Internet
• vigilance guidance issued for coronary stents
• website redesign to facilitate electronic reporting

NICE:

• guidance documents issued
• Support Units to be established
• transparency proposals outlined
• work programme for 2001

Packaging symbols: leaflet available
Safety notices issued by MDA
Symbols for use on packaging: leaflet available

USA
Administrative procedures: revision and amendment of regulations
BIPA: impact on medical devices
Blood and blood components: FDA confirmation in part for final rule
Bloodborne pathogens standard revised
BNP test system: classification
Budgetary priorities: AdvaMed applauds President Bush's stance
Classification of BNP test system
Current Good Tissue Practices (cGTPs): requirements for manufacturers
Electronic records and signatures
Guidance:

• draft documents
• final documents

HACCP: feasibility study for medical device manufacturing
Hazardous materials: review of transportation standards
Home uterine activity monitors: reclassification and codification
Inspections of manufacturers: compliance programme guidance manual available
IVDs: classification of BNP test system
MDMA: 2001 Public Policy Agenda available
Medical errors: final summary published identifying action plan
MRA: EU/USA
Needlestick prevention: bloodborne pathogens standard revised
Orthopaedic devices: reclassification from Class III to Class II
OTC test sample collection systems: reclassification, exemptions and restrictions
Pedicle screws: implications of FDA fraud claims
Pharmacy compounding systems: exemption from premarket notification
Reclassification:

• home uterine activity monitors
• orthopaedic devices
• OTC test sample collection systems

Risk management: HACCP principles
Third party review under EC and US law
Tissue/cellular based products: regulatory framework

Who's Who at the Czech Republic's State Institute for Drug Control
Standards Update
Legislation Affecting Medical Devices in the EU
Meetings of Regulatory Importance

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