DEAL - manufacturer certificates go live for registrable and listable therapeutic device applications

DEAL, the electronic application lodgement system for medical devices, is being developed as part of the overall Strategic Information Management Environment (SIME) computing development at the TGA, and as such is dependent on the delivery timetable for other systems such as the Australian Register of Therapeutic Goods (ARTG). Feedback from DEAL pilot users indicated that the electronic application process is a successful initiative and should be made available to all sponsors as soon as possible.

Given the need to align the implementation of the complete DEAL system with

• the delivery of the ARTG,
• the availability of the new Global Medical Device Nomenclature Coding System (due for release before the end of the year), and
• the progression of the TGA's new medical device legislation,

it is proposed to progress the DEAL implementation in two parts:

1. electronic lodgement of the manufacturer's certificates has been available from 20 November 2000.
2. an electronic medical device application form for entry onto the ARTG of the current registrable and listable therapeutic devices, as well as classes of medical devices as defined in the new legislation, is scheduled for release in May 2001.

This two-part approach will provide early access to DEAL providing sponsors with a more efficient way to meet the current regulatory requirement to provide evidence of Good Manufacturing Practice (GMP) as follows:

"An application for a registrable medical device must be accompanied by current evidence of Good Manufacturing Practice (GMP) specific to that category of medical device, while listed medical devices require GMP if they fall into one of the categories listed in Schedules 6 & 7 of the Therapeutic Goods Regulations."

Sponsors will be able to electronically lodge manufacturer's quality system evidence from both European Notified Bodies (EC Conformity Assessment Certificates and/or manufacturer's Declaration of Conformity) and FDA/other evidence.

Electronically lodged evidence will be:

• checked to ensure that the scope of the certificate assigned by the applicant is supported by the evidence;
• acknowledged by the TGA; and then
• the manufacturer certificate lodgement number can be quoted on paper applications for therapeutic device listing or registration to link the GMP evidence with the paper application, rather than the current GMP process of restricting pre-clearance to a product-by-product process.

Under current legislation, application for the pre-clearance of US FDA Quality System Regulation evidence for a manufacturer who has only been subject to FDA regulatory controls can also be submitted by providing (entering) the FDA-assigned Central File Number (CFN) or Field Establishment Identifier (FEI) number through the DEAL system.

All manufacturer certificates and manufacturer declarations submitted and acknowledged during the DEAL pilot phase will be moved to the 'live' environment and any lodgement number issued will be available for use. The registration of manufacturer's certificates will not incur a charge.

Sponsors who do not already have a userID and password (issued for the pilot) can download a copy of the TGA E-business Client Access form (for DEAL) from the Internet at www.ebs.tga.gov.au (Use the [Apply/New User] icon) and return the form by facsimile to the TGA at 02 6232 8579.

Based on the information provided, a user access profile will be created to enable electronic access to the medical device area in SIME. User information and access details will be returned to the provided email address.

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Device registration news

The Device Registration and Assessment Section looks back on the year 2000 as a highly successful year in terms of registration statistics, Mutual Recognition Agreement (MRA) activities, and the high level of involvement of the Section's staff in developing and preparing for the new device legislation.

At the end of the December quarter, the average evaluation time was 70 days, with 45 submissions finalised in the quarter.

The Section has also celebrated the end of the disinfectant backlog that has existed since 1996. Since that time, 107 applications to register disinfectant products have been received, most during 1996 and 1997, before the deadline for submissions of applications for products that were on the market at the time of introduction of the disinfectant legislation. All applications have now been resolved.

The backlog of submissions over 90 days is also almost resolved. Several of the long-standing submissions were referred to the Therapeutic Devices Evaluation Committee at its December meeting, and action for final resolution recommended. It is expected that the backlog will be essentially cleared during the first quarter of 2001.

The Section issued 5 Certificates under the MRA with the European Union during 2000, with several more inquiries received. These assessments were of Australian products for entry onto the European market. There have been no applications for entry of products from Europe under the MRA.

The TGA has also finalised development of a Standard Operating Procedure (SOP) with the National Serology Reference Laboratory (NRL) on evaluation of tests for diagnosis of Hepatitis C and HIV. The SOP contains agreed performance criteria, and is also expected to help provide more certainty for sponsors in the evaluation process.

The Device Registration and Assessment Section is well placed for a productive and busy year during 2001.

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Listed medical devices and safety evaluation

In June 2000, the TGA introduced changes to the fee structure for medical device applications. One of the changes was the introduction of an evaluation fee of $4000 for assessing whether a Listable or Listed device is safe for the purposes for which it is to be used.

This "safety evaluation" fee will apply only to specified device products. At the present time, the listable devices subject to evaluation include:

• Contact lens care products that require evaluation of preservative efficacy aspects
• Hydrogel dressing products that require evaluation of microbial limit compliance
• Products such as hyaluronic acid injections that are manufactured by means of bacterial fermentation, but are otherwise analogous to products of animal origin. This category also includes artificial body fluids, such as knee or shoulder joint replacement fluids
• Internal adhesives
• Products containing heparin where the heparin is not already included in the ARTG, or otherwise evaluated by the TGA
• High output lasers
• Radiotherapy equipment (brachytherapy sources)
• Radio-active stents
• In-vitro diagnostic devices intended for use in mass screening programs (pending a possible change to the Regulations to make such products registrable).

From time to time, other products may be added as concerns arise or new technology emerges. This will not normally be on an ad hoc basis, but rather as the result of a recommendation from the Therapeutic Device Evaluation Committee (TDEC), recommendation from other areas of the Department of Health and Aged Care or in response to general public health concerns. Such changes in policy may require retrospective evaluation of products already listed on the Australian Register of Therapeutic Goods.

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Scheduling of medical devices

Sponsors are reminded that medical device products containing a substance scheduled in accordance with the recommendations of the National Drugs and Poisons Schedule Committee (NDPSC) must be appropriately labelled as required for the assigned schedule. Labelling requirements are set out in the Standard for Uniform Scheduling of Drugs and Poisons (SUSDP).

Scheduling is controlled at State/Territory level in the relevant Drugs and Poisons legislation which adopt the recommendations of the SUSDP. It is the sponsor's responsibility to ensure that the product complies with the relevant labelling requirements. However, staff coordinating applications for Listing and Registration will normally inform the sponsor of scheduling status, if applicable.

Where a product contains a new chemical entity, ie one that is not already listed on the Australian Register of Therapeutic Goods (ARTG) or the Australian Inventory of Chemical Substances (AICS), consideration by the NDPSC of Poisons Schedule requirements is unlikely to have occurred previously. Chemicals on the AICS but which are being used for the first time as ingredients in a product for domestic use, are also unlikely to have been previously considered by the NDPSC. For disinfectant products containing a new chemical entity, referral to NDPSC, where appropriate, will be done in conjunction with the toxicology evaluation. New disinfectant actives will routinely be referred to the NDPSC for consideration but new and existing excipients will only be referred where the hazard profile of the chemical is consistent with the NDPSC guidelines for inclusion in the various Poisons Schedules. For other products, the decision may be separate from the evaluation process and interim labelling may be required, pending the decision of the NDPSC.

Examples of some device products currently subject to scheduling are:

• Injectable hyaluronic acid (S4 only) - viscoelastics for eye surgery, synovial joint fluid replacement, tissue augmentation
• Injectable collagen (S4 only) - tissue augmentation, tissue scaffolds (implanted), coatings (implanted)
• Injectable polysulfated glycosaminoglycans (S4 only) - viscoelastics for eye surgery, synovial fluid replacement
• Injectable silicones (S4) - tissue augmentation, eye surgery
• Glutaraldehyde for human therapeutic use (S2, S5 or S6) - disinfectants/sterilants, tissue glues (external and internal)
• Gentamicin sulfate (S4 only) - anti-bacterial coating of implants
• Lignocaine (S2 or S4) - analgesic applied to some temporary implants/diagnostic aids
• Heparin for internal use (S4) - blood collection and processing equipment

Sponsors should note that entries in the SUSDP refer to all salts and derivatives of the substance unless specifically exempted.

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Therapeutic Device Evaluation Committee (TDEC) reports

The 2000/2 and 2000/3 meetings of the Therapeutic Device Evaluation Committee (TDEC) were held at the TGA Symonston complex on Friday 21 July 2000 and Friday 1 December 2000.

The major issues discussed during the 2000/2 meeting were:

1. The evaluations of an intra-ocular lens and two disinfectant products;
2. A comparison between two approved systems for biventricular pacing;
3. The St Jude Medical Tempo and Meta 1256 Pacemaker Hazard Alerts;
4. Problem report investigations regarding rechargeable battery packs and the use of closed suction systems on patients connected to ventilators;
5. Standards for Bone Void Fillers;
6. Global Harmonisation Taskforce (GHTF) Guidance Documents;
7. The proposed new regulatory system for medical devices; and
8. The status of preservative efficacy requirements for contact lens care solutions.

The major issues discussed during the 2000/3 meeting were:

1. The evaluations of tissue heart valves, injectable sodium hyaluronate and a home collection sampling device for bowel cancer;
2. Consideration of new technology associated with a specific brand of pacemaker;
3. Problem report investigations regarding injectable sodium hyaluronate, a syringe infusion pump and an insulin injector;
4. Patient Information about complications associated with prosthetic heart valves;
5. The levels of assessment for Class III and Active Implantable Medical Devices;
6. The Global Harmonisation Taskforce (GHTF) Study Group 2 debate on adverse event reporting times;
7. Revision of TDEC's Guidelines on Confidentiality and Conflict of Interest;
8. Consideration of the outcomes from a meeting of TDEC's Advisory Panel on Cardiovascular Devices; and
9. The proposed new regulatory system for medical devices.

The 2001/1 TDEC meeting will be held at the TGA in Canberra on Friday 6 April 2001.

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Update on new medical devices legislation

Australia is harmonising its medical device regulatory system with international best practice based on the recommendations of the Global Harmonisation Task Force, and the European medical device requirements. It is anticipated that the new regulatory system will be implemented in 2001.

Work is progressing on the amendments to the Therapeutic Goods Act 1989 and an exposure draft of the Therapeutic Goods (Medical Devices) Amendment Bill will be available for industry comment in early February. It is expected that the Bill will be introduced into Parliament in the Autumn Sitting 2001.

The new Act will be restructured into chapters with a new chapter for medical devices. There will also be a separate set of Medical Device Regulations for the new regulatory system.

Medical devices on the Australian Register of Therapeutic Goods (ARTG) at the date of implementation will have five years to meet the new regulatory requirements. Some new medical devices, including currently exempt medical devices, will have two years from the date of implementation to comply with the new requirements.

Update on the regulation of disinfectants

A meeting of the Disinfectant Working Group was held on 5 December 2000. The review of the Draft Guidelines for the Evaluation of Sterilants and Disinfectants was discussed. A number of amendments were considered with industry agreeing to provide further comments on a revised draft document.

Industry has nearly finalised their Industry Code of Practice for Household Cleaning Products. This will be a voluntary code for those products making antibacterial claims but excluded from being regulated under the Therapeutic Goods Act 1989. The Code will provide a standard practice for sponsors wishing to make claims for products outside of the TGA's regulatory scope.

The Working Group reiterated their support of the move to shift hospital grade disinfectants (with specific claims) and household/commercial grade disinfectants (with specific claims) from the registrable category to the listable category on the Australian Register of Therapeutic Goods.