Questions & answers about regulating medical devices
October 2006
Has a study or research of New Zealand medical devices been undertaken to compare differences with Australia?
A study of the New Zealand medical device sector and its comparison with Australia has not been undertaken as part of the proposals. However, as part of the development of the fees and charges discussion paper, modeling and assumption work has been undertaken using product information available on the Medsafe WAND database.
Will there be anyone on the Authority Board who will be experienced in the medical devices industry?
The five-member Board of the Joint Authority will be appointed by the Ministerial Council as set out in article 6 of the Agreement or Treaty. The Board will be responsible to the Ministerial Council for the governance of the Authority however it will not be responsible for the Authority’s regulatory functions.
The five members on the Board will be made up of:
- The Chair
- The Managing Director of the Authority
- A member with broad commercial expertise
- A member with broad experience in public health and regulatory matters in New Zealand; and
- A member with broad experience in public health and regulatory matters in Australia.
A number of Expert Advisory Committees will also be set up to provide advice to the Authority, including one for medical devices.
Are we going to see unique regulations for the New Zealand medical devices sector? Or is this joint proposal the widening of the TGAs current scheme?
The proposed regulatory scheme for medical devices is a joint proposal for both the New Zealand and Australian markets based on the Global Harmonization Task Force (GHTF) framework. The proposed joint regulatory scheme aims to bring New Zealand’s regulations in line with international best practice for the regulation of medical devices. Once established the joint Authority will replace Australia’s Therapeutic Goods Administration and New Zealand’s Medicines and Medical Devices Safety Authority Medsafe. The new Authority will be similar to a Crown owned entity in New Zealand or a Commonwealth Authority in Australia. It will be equally accountable to the Parliaments of Australia and New Zealand and will also have offices based in both countries.
What is the timeframe for the approval and licensing of medical devices and will the timeframe targets be published?
The timeframes for assessing medical devices and issuing product licences will vary depending upon the level of risk of the device, the level of assessment required, the type of manufacturing certifications submitted and whether additional information is sought during the assessment process.
Applications for Export only products that require no further assessment are expected to be processed in approximately 5 working days from the date of receipt.
Applications submitted under a Mutual Recognition Agreement (MRA) will be issued with a product licence within a few days without any additional assessment.
The majority of applications for low risk devices are expected to be processed and issued with a product licence within 20 working days after receiving the application.
The majority of medium risk devices, where no audit is required of the manufacturing facility, is expected to be completed within 60 – 90 working days, provided the application is complete and contains all the relevant data.
Applications for high risk devices that need a full assessment including an audit of the manufacturer may take several months depending upon the data submitted and the scheduling for the audit.
The timeframes for assessment also need to take into consideration any additional days that may be required where advice on the medical device is sought from an Expert Advisory Committee.
When would the New Zealand database WAND be joined with Australia?
The WAND database will cease to exist after the joint scheme commences and a new database for approved New Zealand and Australian medical devices will come into existence.
When the joint regulatory scheme comes into effect all products listed on New Zealand’s WAND database will be issued with an interim product licence to allow that product to continue being supplied in the New Zealand market during the proposed three year transition period.
All products legally available within the Australian market at the time the joint scheme goes live will also be issued with an interim product licence, which will allow the products to continue being supplied in the Australian market.
At any time during the proposed three year transition period, a product sponsor can apply to the Authority for a full ANZTPA product licence which would allow a medical device to be supplied in both the New Zealand and Australian markets.
What happens in the case where overseas manufacturers have medical device distribution points in both New Zealand and Australia?
Each company that imports a product from an overseas manufacturer will need to apply for a product licence under the joint scheme.
However these importing companies may choose to work together so that one company holds the product licence. These would be business decisions and different companies will have different requirements and ways that they will choose to operate under the proposed joint scheme.
Will this proposed regulatory scheme differ from that of the TGA?
The proposed regulatory scheme for medical devices is based upon the regulatory model developed by the Global Harmonization Task Force (GHTF). This model was adopted by Australia in 2002. The proposed joint scheme takes into consideration the Australian experiences with the GHTF model, and has been modified to accommodate the needs of both Australia and New Zealand.
How much is it going to cost? Will medical devices cost more to purchase?
The total cost of regulating devices for both New Zealand and Australia is estimated to be at its highest A$15.5 million in the first year of operation. It is estimated, based on a set of assumptions about the New Zealand and Australian market, that New Zealand companies would pay just under 15% of this cost.
As part of the development of the discussion paper on the proposed fees and charges, the assumptions about the New Zealand market were checked with industry organisations, including MIANZ. Further checking of these assumptions occurred as part of the first phase of consultation which closed on 15 August 2006. Stakeholder views were sought (particularly in relation to the estimates and assumptions about the New Zealand and Australian markets that have underpinned the development of the proposed model) in order to inform the development of the draft Rule on fees and charges.
Will Mutual Recognition Agreements with other countries be recognised?
The Mutual Recognition Agreements (MRAs) that are currently in place for both New Zealand and Australia will continue to be recognised under the joint scheme.
Australia and New Zealand each have an MRA with Europe covering product approvals. Applications for medical devices with overseas conformity assessment certificates issued under these MRAs, will be issued with an ANZTPA product licence without undergoing additional pre-market assessment. Likewise, New Zealand and Australian manufacturers with a conformity assessment certificate issued by ANZTPA under these MRAs will be accepted without further assessment in Europe.
The TGA is progressing negotiations on a Memorandum of Understanding (MOU) with Health Products Food Branch, Health Canada to recognise Quality Management System (QMS) audits of medical device manufacturers. Once this agreement is in place, and the Authority commences, Australian and New Zealand manufacturers of medical devices will be able to export their products to Canada without the requirement to undergo duplicate audits of their QMS.
The TGA has also commenced informal discussions with the United States Food and Drug Administration (FDA) to scope the feasibility of a similar arrangement between the FDA and ANZTPA.
There is also scope under the joint scheme for the ANZTPA to take into consideration, conformity assessment certificates for medical devices issued by conformity assessment bodies outside the MRA, as part of the overall assessment for a product licence. However, the ANZTPA will reserve the right to reject a certification or conduct an inspection of the manufacturing site if this appeared to be warranted.
There is also an in principle agreement to the use of third parties for assessing Australian and New Zealand manufacturers of medical devices, with the ANZTPA making the final licensing decision. The operational details are yet to be developed.
Can you still market a product just for one market?
An ANZTPA product licence authorises supply of a therapeutic product in both Australia and New Zealand, but the product licence holder can decide to supply in one country only. There is no proposal to issue a product licence that applies in only one country except if there was an exceptional circumstance as contemplated in the Treaty that was signed by both countries in 2003. An exceptional circumstance could arise for cultural, third-country trade, environmental, public health or safety reasons.
There are a small number of products such as tampons and disinfectants that will continue to be regulated by ANZTPA for Australia only. There are no plans to regulate these products in New Zealand under the joint scheme.
Will there be conformity for products which traverse the medical device and medicines regulations in that they could be a device in one country but are considered a medicine in the other? Where would they fit in under the new scheme?
Under the joint scheme, there will be a common definition of medicine and of medical device.
What benefits will industry gain from the joint ANZTPA regulatory scheme?
Benefits of the joint regulatory Scheme include:
- Medicines and medical devices approved for supply in one country would also be approved for supply in the other country helping to limit the licensing and approval costs for the manufacturer and giving New Zealanders and Australians access to the same products;
- Enabling a sustainable regulatory capacity for therapeutic products in the short, medium and long-term;
- Introducing appropriate risk-based regulation consistent with international best practice.
- International recognition of the ANZTPA regulatory stamp of approval which will open the way for exports of New Zealand and Australian therapeutic products to other countries; and
- Encouraging closer economic ties between the two countries.
Will the joint Authority be a notified body?
The Authority will not be a notified body. However it will be recognised by the European Union (EU) member states as a body that can conduct conformity assessments against EU requirements and authorise placement of the CE mark on medical devices.
How will barriers to trade be overcome?
The establishment of the Authority and the regulatory scheme will enhance trans-Tasman co-operation under the Closer Economic Relations agreement and the trans-Tasman Mutual Recognition Arrangement. An ANZTPA product licence will allow a product to be supplied in both the New Zealand and Australian market.
What will happen regarding the advertising standards for dental products and will these products be regulated as medical devices?
Dental products that meet the definition of a medical device under the draft Rule will be regulated by ANZTPA as medical devices, likewise the advertising requirements for medical devices under the joint scheme will also apply.
Will there be timelines for conformity assessments?
Yes. ANZTPA will have target times agreed with industry for conformity assessments. The experiences of the TGA in meeting target times for processing applications for the different risk categories of medical devices will provide important information for developing target times under the joint scheme.
Under transition, how do you cope with the scenario that there may be more than one company distributing a product?
It will be up to individual companies to make a business decision about how to approach this situation.
However, it is possible that there will be a number of companies placing the same product on the market from the same manufacturer. Each company will need a product licence from ANZTPA and will hold the regulatory responsibility of the products they supply.
URL: http://www.anztpa.org/devices/qameddev.htm