Medical Technology Regulation

An Insight Into Medical Device Requirements in Kenya

March 19, 2012 | by Philippa Moore

The Kenyan Pharmacy and Poisons Board have released draft guidance (January 2012) specifying minimum requirements for advertising and promoting drugs and medical devices. The document is aimed at ensuring the legal framework is adhered to and that the message received by consumers from therapeutic goods manufacturers is factual and evidence based.

Drug and device manufacturers and distributors are responsible for the statements and activities of their sales and marketing representatives and must ensure the representatives working for them are authorised by the Kenyan Pharmacy and Poisons Board and comply with the requirements specified.

The guidance formalises that no medical device can be marketed without registration with the Kenyan Pharmacy and Poisons Board and that misleading statements cannot be made.

For a copy of the guidance or information regarding regulatory requirements in international markets, contact KD&A.

This article appears in the categories Medical Technology Regulation News

Brazil IVD Requirements – Aligned with GHTF Principles

March 2, 2012 | by Philippa Moore

Brazil’s regulatory agency, Anvisa, has introduced reforms to simplify classification processes for IVD products. From the 18^th of May 2012 IVD manufacturers will be subject to new regulations which are aligned with the Global Harmonisation Task Force (GHTF) principles and therefore similar to the world’s major IVD markets. The new system is characterised by 9 classification rules which are based on the following 5 criteria:

The product’s indication, as specified by the manufacturer;
The level of technical, scientific, or medical knowledge of the user;
The importance of the information generated by the test result to establish the diagnosis;
The importance and impact of the result for the individual patient and for public health; and
The epidemiology implications.

The new regulations will replace the current classification system (adopted under Resolution RDC 206/2006) which does not establish the rules defining how product risk should be determined by the manufacturer. Anvisa recognise the current regime has resulted in confusion within the industry. It is consequently hoped the new regulation will bring clarity and assist manufacturers to develop the required registration documentation.

Contact KD&A for further information relating to accessing international IVD markets or visit our services page.

This article appears in the categories Medical Technology Regulation News

In-house IVDs – TGA Release New Guidance

February 23, 2012 | by Philippa Moore

The TGA have published a guidance document for manufacturers of in-house IVDs (in-vitro diagnostic device) to assist in ensuring compliance with the new regulatory framework, released on 1 July 2010. The guidance is easy to understand and is a must read for Australian in-house IVD manufacturers.

An in-house IVD is defined as the following in the Therapeutic Goods (Medical Devices) Regulations 2002 as amended, Regulation 1.3:

An in-house IVD device means an IVD medical device that is:

(a) Within the confines or scope of an Australian medical laboratory or Australian medical laboratory network:

i. Developed from first principles; or

ii. Developed or modified from a published source; or

iii. Used for a purpose, other than the intended purpose assigned by the manufacturer; and

(b) Not supplied outside that medical laboratory or medical laboratory network.

In-house IVDs are, in general, pathology tests that have been developed or modified by a medical laboratory to carry out testing on human samples, where the results are intended to assist in clinical diagnosis or in making decisions concerning clinical management. The regulations are not limited to NATA accredited medical testing laboratories but extend to all laboratories that manufacture in-house IVDs as prescribed in the regulations. There are three broad situations where, in accordance with Regulation 1.3, a laboratory is considered to have manufactured an in-house IVD.

In-house IVDs must be classified according to the classification rules given in the Therapeutic Goods (Medical Device) Regulations 2002 as amended. Based on the determined classification conformity assessment procedures shall then be followed.

All Class 4 in-house IVDs shall comply with the requirements defined for commercially supplied Class 4 IVDs.

The conformity assessment procedures for Class 1-3 IVDs are specified in Schedule 3, Part 6A of the Regulations. To meet the basic requirements, the following activities must be completed:

Notify the TGA annually of the contact details of the laboratory and provide the name and risk class for each in-house IVD manufactured. This must be completed annually via the TGA’s online system, eBusiness. Details will be recorded on the In-House IVD Notification Database.
Meet the requirements defined in by the National Pathology Accreditation Advisory Council (NPAAC) performance standard.
Obtain and maintain National Association of Testing Authorities (NATA) accreditation (or conformity assessment body accreditation (as deemed suitably by the TGA)).
Meet the standard ISO 15189 Medical Laboratories – Particular Requirements for Quality and Competence.

The manufacturer (the laboratory) is required to hold information in relation to their quality management system, the design and manufacture of each in-house IVD and other documentation specified in the NPAAC standard. A post market system must also be implemented.

With a transition period that begun in 2010, in-house IVD manufacturers have until the 30 June 2014 to comply with the specified requirements. It is recommended manufacturers demonstrate compliance as soon as possible to avoid a long TGA review period.

The TGA Guidance can be found at http://www.tga.gov.au/pdf/ivd-regulatory-requirements.pdf.

For assistance completing regulatory activities for in-house IVDs, contact KD&A.

This article appears in the categories Medical Technology Regulation News TGA

What Does Recall Really Mean? The GHTF Aim to Provide Clarity

February 16, 2012 | by Philippa Moore

The recent PIP breast implant saga is a reminder of just how important it is for us, the medical device industry, to have a universal system for identifying, classifying and resolving product recall situations. Despite its importance, the term recall is currently not harmonised. The term has different meanings depending on region which can result in confusion for regulatory authorities and users worldwide. The Global Harmonisation Task Force (GHTF) has released a draft guidance document which may just pave the way for harmonised terminology, clarifying things for all medical device manufacturers.

The guidance document defines Field Corrective Actions (FCAs) which include Field Safety Corrective Actions and Non Safety related Field Corrective Actions. The actions are classified based on the type and extent of the corrective action and importantly, the level of risk posed to patients, users or others affected by the device’s use. The classification system provides a mechanism for manufacturers to develop comprehensive strategies including planning for communication, action and follow up and for regulatory authorities to monitor progress of the FCA.

The guidance document provides practical examples of each type of FSCA (of which there are 5) and Non Safety related Field Corrective Actions (of which there are 3). These are given below.

Safety Related Field Corrective Actions (e.g. FSCA):

Device Removal (Device Recall)
Device Modification
Implant Alert
Device Precaution
User Warning

Non Safety related Field Corrective Actions:

Device Withdrawal
Device Enhancement
Stock Recovery

The classification system requires manufacturers to propose an expected level of risk to patients, users and others if use of the device was to continue. Classification of FCAs is divided into 3 levels, these are given below:

FCA Class I: Taken by a manufacturer when death or serious deterioration in the state of health of a patient, user or other person has occurred, or there is a reasonable probability that exposure to or use of the device can lead to death or a serious deterioration of health.
FCA Class 2: Taken by a manufacturer when there is a reasonable probability that the exposure of use of the medical device has or can lead to temporary illness, injury, mistreatment or deterioration of the state of health of a patient, user or another person
FCA Class 3: Taken by a manufacturer when there is a reasonable probability that the exposure or use of the device will not lead to temporary illness, injury, mistreatment or deterioration in the state of health of a patient, user or other person.

Whilst still in draft form, the document does provide useful guidance and is a must read for all medical device manufacturers. Find it here.

KD&A can assist your organisation to develop suitable post market procedures to ensure you are prepared and can comply with the regulatory requirements in the markets into which you sell your devices. Visit the Post Market Surveillance System page or contact KD&A.

This article appears in the categories Medical Technology Regulation News

Changes Afoot for Medical Device Manufacturers in Argentina, Brazil, Colombia and Cuba

February 1, 2012 | by Philippa Moore

The agencies which regulate medical devices in Argentina, Brazil, Colombia and Cuba have initiated plans to work together to recognise certification of medical device manufacturers. The regulatory bodies ANMAT (Argentina), ANVISA (Brazil), INVIMA (Colombia) and CECMED (Cuba) have recently signed an agreement as a result of an initiative which was passed during the Pan-American Health Organisation (PAHO/OPS) September/October 2010 summit.

The details of the mutual agreement are to be defined during 2012 and it is hoped that the agreement will be operative from 2013. The four regulatory bodies will work independently to begin with to certify manufacturers as compliant with mutually recognised good manufacturing practice (GMP) standards. This model will then adapt to allow for joint inspections to the GMP standards. Down the track it is planned that other activities (including product recall) will be completed on a mutual basis.

The mutual agreement will mean reduced regulatory burden for medical device manufacturers in these regions, and may eventually broaden to bring benefit to overseas manufacturers also. As with many other regions worldwide, a mutually governed approach to medical devices is developing.

For assistance obtaining regulatory certification outside of Australia, please contact KD&A.

This article appears in the categories Medical Technology Regulation News

The Australian Government Release a Blueprint for TGA’s Future – How Does This Affect Your Organisation?

January 9, 2012 | by Philippa Moore

The Australian government released the Blueprint for TGA’s future in early December 2011 which describes the results of 18 months of discussion and review of proposed reforms. The reforms are designed to improve the transparency and efficiency of therapeutic goods regulation and will affect almost all manufacturers and sponsors of therapeutic goods in Australia.

The government’s blueprint includes the following:

Plans to focus on improving communication and engagement with the community with the intention of becoming a well known and understood regulatory agency.
Plans to establish an Australian Therapeutic Goods Advisory Council which will facilitate direct public feedback and comment on TGA activities
An intention to improve current arrangements for the regulation of therapeutic goods advertising by creating a central point for all complaints about advertising, and the development of options for further consideration.
A plan to update and include in the regulation of complementary medicines the ‘guidelines for the levels and kinds of evidence to support indications and claims’ to increase rate of compliance with regulatory and legislative requirements.
Medical device reforms including increased rigour of pre-market regulatory assessment of high risk devices, reclassification of load bearing joint replacements (from Class IIb to Class III), a requirement that Australian Register for Therapeutic Goods (ARTG) inclusions to specify all devices sold under each ‘kind of medical device’ inclusions, and an increase in the product information available on the TGA website.
A commitment to maintain an emphasis on self-regulation of industry in relation to promotion of therapeutic goods.
An indication that a modest increase in fees will apply to implement the fundamental reforms.

Whilst reforms are welcomed, there appears to be some disappointment in the failure to implement reforms to create equality in the promotion of therapeutic goods. Based on the government’s current stance, a level playing field appears somewhat out of reach for industry. It has also been said that an increase in fees is likely to be not well received by sponsors and manufacturers in Australia, with current fees already considered to be significant for smaller companies.

For manufacturers and sponsors, the reality of the reforms is here, meaning it is time to prepare your organisation to comply with the requirements or implement plans to do so. For medical device reforms, transition periods apply however it is recommended that a focus on compliance within your organisation is actioned as soon as possible.

To better understand new requirements for your organisation and for guidance regarding the most effective way to comply, contact KD&A.

This article appears in the categories Medical Technology Regulation News TGA

IEC 60601-1, 3rd Edition

December 16, 2011 | by Philippa Moore

IEC 60601-1 third edition has become a common subject of discussion for medical device manufacturers in recent times. The third edition of 60601-1 represents an overhaul of the 60601 group of medical electrical equipment safety standards.

A commonly used standard, 60601-1 is an important tool for manufacturers when demonstrating compliance with the Essential Principles and Essential Requirements. Standards selection and compliance is an important component of device development, manufacture and testing.

Some changes debated and included in the third edition of 60601-1 are as follows:

The scope of 60601-1 has been expanded to include automatic external defibrillators (AED).

The definition of medical electrical equipment has been expanded to add ‘or compensation or alleviation of disease, injury or disability’ to the definition of medical electrical equipment. Historically, medical electrical equipment was limited to devices intended by their manufacturer to ‘diagnose, treat or monitor a patient.’

Collateral standards in the IEC 60601 family have become a normative part of the general standard on the date of its publication. In effect, this approach allows for an unlimited number of amendments to add new general requirements to IEC 60601-1 because each new collateral standard becomes a nominative part of IEC 60601-1 when published.

However, the most significant change is the requirement for the manufacturers of electromedical equipment and systems to have a formal risk management system in place in order to comply with the third edition of IEC 60601-1.

There is much cross over between ISO 14971, the risk assessment standard for medical devices, and 60601-1 third edition. For example, 60601-1 features over 100 instances where applications of a specific clause, modification of a test protocol, or provisions of a particular safety feature depend upon a determination that the risk is acceptable (or that there is unacceptable risk). Manufacturers must determine risk acceptability using ISO 14971 complaint risk management process.

For many medical device manufacturers, ensuring compliance with the third edition of 60601-1 is an important issue. Whilst there are many publically available guidance documents online, KD&A recommend working with electrical safety experts in order to properly understand specific product requirements based on the third edition requirements and complete necessary activities to achieve and maintain ongoing compliance.

This article appears in the categories Medical Technology Regulation News

Premarket Evaluation of High Risk Medical Devices in the EU

November 14, 2011 | by Philippa Moore

Recently the EU has come under heavy scrutiny for failing to produce adequate premarket clinical evidence that demonstrates efficacy and safety of innovative, higher – risk medical devices.

Medtech experts from around Europe have collaborated to produce a report in which they argue that it is time to introduce randomised clinical trials (RCTs) in the EU for high risk medical devices (these are defined as innovative Class III medical devices and innovative implantable medical devices).The authors also propose centralising the evaluation process of these products. (more…)

This article appears in the categories EU Medical Technology Regulation News

Some IVDs and Radiology devices to be exempt from FDA 510(k)

November 3, 2011 | by Philippa Moore

The FDA (US Food and Drug Administration) has announced plans to ease the pre-market notification, or 510(k), requirements for certain in-vitro diagnostic (IVD) and radiology devices with well established safety and effectiveness profiles.

In a draft guidance document, the agency has listed 30 different device types that it intends to exempt from 510(k) notification requirements through the appropriate regulatory processes.

Stakeholders had until October 2011 to submit feedback on the guidance, which includes devices for which FDA believes that a less stringent oversight would not compromise public health and safety. These include common urine and blood tests, alcohol breath tests, blood clotting protein tests and radiology device accessories such as film cassettes, film processors and digitisers.

The majority of devices listed in the guidance document are currently medium risk (class II) or low risk (class I), with respect to class II devices, the FDA intends to propose their down-classification and exemption from the 510(k) review, while class I devices it will propose an amendment to the classification regulations to exempt these devices from the 510(k) requirements.

These devices, however, would be still subjected to other requirements such as those pertaining to labelling, good manufacturing practises, and medical device reporting.

Until the FDA proposes and finalises such down-classification and exemption, it will exercise enforcement discretion with regard to 510(k) submission requirements for these devices.

This means the FDA do not intend to enforce the 510(k) requirements with respect to the devices listed in the guidance document provided that they do not exceed the limitations on exemption specified in the classification regulations.

To view the draft guidance document, visit the FDA website. For assistance obtaining US FDA clearance, contact KD&A.

This article appears in the categories FDA Medical Technology Regulation News

EU publish much awaited draft regulation for e-labelling of medical devices

October 27, 2011 | by Philippa Moore

The European Commission has finally issued it’s much awaited draft regulation on e-labelling, the final version of which is expected to be adopted by 14 December and come into force during 2012.

The proposed regulation sets out conditions under which instructions for use in paper format may be replaced by electronic versions with respect to medical devices that are intended for exclusive use by professionals users and for which use by other persons is not reasonably foreseen.

While acknowledging the benefits of e-labelling, the commission states that the possibility of providing instructions for use in electronic form instead of paper should be limited to certain medical devices and accessories intended to be used in specific conditions.

For reasons of safety and efficiency the draft regulation indicates that medical device users should always have the option of obtaining the instructions for use in paper form on request. The regulation also includes several other procedural safe guards. For example, it requires manufacturers to carry out a documented risk assessment to ensure the appropriateness of providing electronic instructions. This risk assessment should, among other things, demonstrate that providing electronic instructions maintains or improves the level of safety achieved by providing the instructions for use in paper form. The risk assessment will need to be updated in view of experience gained in the post market phase.

The proposed regulation states that electronic instructions for use should be available through a website to ensure unconditional access and to facilitate the communication of updates and product alerts. Regardless of the language related legal obligations imposed by EU member states, the regulations state that manufacturer should indicate on their website in which EU languages the electronic instructions for use are available.

Except for class I medical devices, the commission believes that the fulfilment of obligations laid out in the regulation should be reviewed by a notified body. The draft regulation lists the devices for which electronic instructions for use can be provided.

When finalised, the regulation will be published in the Official Journal and is expected to come into force one year after the publication date.

For a copy of the draft regulation can be found at the European Commission website. Contact KD&A for assistance to establish e-labelling for your medical device.

This article appears in the categories EU Medical Technology Regulation News