KD&A

The Kenyan Pharmacy and Poisons Board have released draft guidance (January 2012) specifying minimum requirements for advertising and promoting drugs and medical devices.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.

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.

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):

1. Device Removal (Device Recall)
2. Device Modification
3. Implant Alert
4. Device Precaution
5. User Warning

Non Safety related Field Corrective Actions:

1. Device Withdrawal
2. Device Enhancement
3. 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:

1. 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.
2. 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
3. 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.

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.

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.