Experts agree on the need to regulate manufacturing and imports based on the level of risk or invasiveness involved and warn about the importance of validating foreign certification. These actions will contribute to the application of improved standards and increased patient access to new treatments.
By Kamila Cortez
The concept of what constitutes a medical device is broad, ranging from a syringe, to a pacemaker, to medical software. Many of these devices relate to articles that are used on a daily basis by a large number of people, including band-aids, thermometers and spacers for inhalers, as well as others that are essential for the evaluation and diagnosis of medical conditions, such as X-ray equipment, blood analysis machines and CT scanners. Medical devices also include items that help to prolong and improve the quality of life, including mechanical ventilators, prostheses and dialysis machines. In other words, the term ‘medical device’ corresponds to a great variety of articles, equipment, instruments and elements that are used in the medical field to improve the health of patients and which are crucial for the safe and efficient prevention, diagnosis, treatment and rehabilitation of illness, disease and injury. These devices play a central role in the development of public health and are critical to highly complex and orthopedic treatments and therapies; all with a view to help secure a more inclusive society.
In terms of the current Chilean medical device industry, domestic manufacturing accounts for approximately 10% of the total market. The principal devices made in Chile include in vitro diagnostic kits, dialysis concentrates, surgical clothing, certain dental implants, incontinence nets and latex gloves, among others. The remaining 90% of medical devices present in the Chilean market are imported and according to the study, Medical Device Market by Product Area 2014, the breakdown of these imports is as follows: 33% comes from the United States; 14% from Germany; 10.5% from China; 4% from Mexico; 3.8% from Japan; and 34.3% from other countries.
Chilean law classifies medical devices as belonging to one of four groups, according to their associated level of risk. Class 1 relates to the lowest risk and includes bandages, cervical collars and stethoscopes; Class II includes removable dental prostheses and surgical gloves; Class III is comprised of elements such as condoms, dialysis machines and anesthesia machines; and Class IV, which relates to the highest risk, includes intrauterine devices and heart implants, and valves, among others.
Changes to Chilean law
Medical devices in Chile are regulated by article 111 of the Health Code and Supreme Decree (DS) 825/98. This legislation governs the quality control and certification of all products that are manufactured, imported, sold or distributed in the country. In turn, such activities can only be undertaken by entities that have secured prior authorization of the Public Health Institute of Chile (ISP).
Article 22 of DS 825/98 stipulates that the effective and progressive application of regulations pertaining to different medical devices and elements is by means of Supreme Decree. However, Juan Alberto Lecaros, director of the Observatory of Bioethics and Law at Universidad del Desarrollo, argues that legislation is insufficient in its current form to guarantee the safety of imported high-risk devices. He highlights the facts that there is only one certifying body to conduct quality controls in Chile and that this entity only assesses five devices: medical examination and surgical gloves, condoms, and hypodermic needles and syringes.
“Therefore, there is a lack of institutional capacity to comply with the current law which demands that all devices, particularly those classified as high risk, such as invasive implants and devices for prolonged use, must be subject to quality control and certification by domestic certifying entities”, states the academic.
Lecaros adds that by means of the new Medical Drug Act II, which is currently being debated by the Health Commission in the Senate, possible amendments to article 111 that regulates medical devices are being discussed. These amendments would, essentially, allow for the recognition of foreign certifications in the absence of certifying bodies in Chile.
“While the main sentiment behind this amendment is along the right lines, the act could be simplified to provide more space for the respective ruling. The greatest impact on the medical device market does not come from this legislation but rather the Ricarte Soto Act, which regulates clinical trials. (However) the deficiency of the provisions (of the Ricarte Soto Act), which are lacking in terms of international standards, will simply disincentivize national manufacturing of medical devices” states Lecaros.
In the opinion of Dr María Teresa Valenzuela, Vice Dean for Research and Graduate Studies at the Faculty of Medicine of Universidad de los Andes, the proposals contained within the Medical Drugs Act II establish the need to regulate the medical device market. However, she warns that given the large quantity of medical devices currently on offer, any progress towards the control thereof should be undertaken gradually and with priority given to high-risk and invasive equipment. “(This law) will have a positive impact, as long as it prioritizes those (devices) which need to be the subject of control, which should be based on agreements related to invasiveness criteria”, she says.
According to Janepsy Díaz, Head of the Department of Scientific Affairs at ISP, the amendments will improve the system of registering suppliers and distributors. In turn, this will facilitate the compliance of relevant entities with their auditing responsibilities, as well as extend the list of products subject to mandatory control, optimize the registration process, and help to ensure that the general public has access to safe and effective products. “Towards this end, a mechanism for post-sale health surveillance has been proposed, which in the case of medical devices is known as ‘techno-surveillance’, to verify that initial standards are maintained overtime and throughout the country”, she adds.
Díaz stresses that the main impact of the amendments will be to increase sanitary control of medical devices. This will help to guarantee that the general public has access to safe, effective and appropriate equipment that is traceable from the supplier to the medical center where it is used, including in the case of medical devices that are implanted into patients.
Valenzuela states that most countries do not tend to implement quality control. However, she points out that techno-surveillance, which proposes to collect information related to adverse events occurring with a medical device by verifying its safety, as well as ongoing auditing is obligatory.
“The standards with which medical devices should comply are outlined in ISO 13485, which relates to quality management in manufacturing. In Chile, there is only one certification body overseeing the quality of these products, the Centre for Measurement Study and Quality Certification (CESMEC)”, she notes.
The view from the private sector in regard to the legislative amendments is favorable. Esteban González, LA Regulatory Affairs & Quality Compliance Leader of the Health Care Business at 3M says that, “Chile is practically the only country in the region that does not regulate medical devices. It is important to differentiate between quality certification and quality control because products entering the country may have certification that is issued by a manufacturer, but they do not currently undergo quality control by a health-related body”.
González believes that the legislation will improve the level of certainty, from the point of view of the regulator, in relation to the quality and effectiveness of the products that are sold in Chile. However, any regulation implies the application of controls and industry compliance with the new requirements. Depending on how these new requirements are implemented, it is likely that they will lead to changes in registration times and costs, among other factors. “This is not a bad thing for the industry because it establishes rules, regulations and standards that should be the same as those applied across virtually all countries in the region”, he states.
González adds that steps are being taken at the international level to harmonize and connect regulation in this field. For example, the World Health Organization, by means of its International Medical Device Regulators Forum (IMDRF), has published recommendations to governments on the implementation of harmonized regulation systems. Essentially, the harmonization consists of validating quality certifications, whether they relate to processes, manufacturing, or the product itself, as well as in cases when devices stem from countries that have strict quality control agencies, including the United States, members of the European Union, Canada, the United Kingdom and Japan.
Tulio Oliveira, Business Unit Director – Southern Cluster at Johnson & Johnson, shares this view. He warns that Chile needs to pass new legislation in this area and to do so in line with international standards. He also argues that this legislation should understand the particular characteristics of the industry by helping to increase access to medical devices.
On one hand, Oliveira agrees that new regulations are required to ensure quality, safe and efficient medical devices. On the other, he states that it is necessary to differentiate between legislative discussions about medicines and those related to medical devices. The latter, he states, are still being debated under the framework of the Medical Drugs Act II, in circumstances that require different kinds of discussions.
“It is important to maintain a regulated environment, but at the same time it is necessary to ensure that the public has access (to medical devices) by breaking down the economic or technical barriers that can make this difficult”, he notes.
Oliveira claims that one of the key aspects for the development of the sector is to recognize certifications issued by health authorities in the United States, the European Union, Canada and the United Kingdom, since they have conducted more advanced work in this field. This will help to avoid duplications in terms of control measures.
In order to promote dialogue between the public and private sector as a means of contributing to the development of the medical devices industry, the Chilean-American Chamber of Commerce, AmCham Chile, has formed a committee that specializes in this field. The aim of this committee is to leverage international experience and know-how of companies operating in the sector to address the main challenges related to standards of quality, safety and transparency.
“Health is a fundamental pillar of the wellbeing of the general public and an essential element in achieving equitable and inclusive development. That is why we are interested in promoting public-private dialogue through the Health Committee, actively contributing to the process of transforming the sector so that it reaches the highest possible standards of quality, safety and transparency in terms of its impact on public health”, explains Tatiana Molina, Content Manager at AmCham Chile.
She adds that in the healthcare industry, the medical devices sector is one of the most complex and challenging business segments but in which there is close collaboration between science and engineering. This means that the industry is subject to rapid and continuous evolution, with emphasis on the wellbeing of individuals.
In conclusion, it will be necessary to monitor the progress of the amendments to article 111 of the Medical Drugs Act II in Congress. In particular, it is important to gauge how advantageous advancements in this field will be to the country, not only in regard to quality, but also in terms of availability and access to medical devices.