Key Regulatory Agencies and Authorities

Introduction

  • Navigating the global regulatory environment is essential and challenging.
  • This chapter serves as a guide to key regulatory agencies across various regions, including:
    • North America
    • Europe
    • Africa
    • Asia
    • Latin America (LATAM) and the Caribbean
    • The Middle East and North Africa (MENA)
    • Oceania
  • The chapter explores:
    • The scope, roles, and responsibilities of these agencies.
    • The unique regulatory framework in each region.
    • Global harmonization initiatives that started in 1992 with the Global Harmonization Task Force (GHTF) and continue through the International Medical Device Regulators Forum (IMDRF).
  • Provides an overview of primary agencies in major countries, detailing how they regulate:
    • Medical devices
    • Combination products
    • In Vitro Diagnostics (IVDs)
  • Discusses upcoming regulatory changes.
  • The goal is to equip stakeholders with a comprehensive understanding of global bodies responsible for the regulation and advancement of medical devices, combination products, and IVDs through international compliance and market entry.

North America

  • Table 3-1 provides a list of Regulatory Agencies for North American countries.

United States (US)

  • Medical devices, combination products, IVDs, and other device-related healthcare products are regulated by the US Food and Drug Administration (FDA), an agency within the Department of Health and Human Services (HHS).
  • The FDA includes:
    • Center for Devices and Radiological Health (CDRH)
    • Center for Biologics Evaluation and Research (CBER)
    • Center for Drug Evaluation and Research (CDER)
    • Multiple headquarters (HQ) offices across the country.
  • Field activities, such as recalls, market withdrawals, bioresearch monitoring, and inspections, are conducted by FDA's Office of Regulatory Affairs (ORA).
Medical Devices
  • Medical devices and radiation-emitting electronic products, including x-ray and ultrasound equipment, are regulated by CDRH.
  • CDRH is divided into seven offices:
    • Office of the Center Director (OCD)
    • Office of Management (OM)
    • Office of Strategic Partnerships and Technology Innovation (OST)
    • Office of Science and Engineering Laboratories (OSEL)
    • Office of Communication and Education (OCITE)
    • Office of Product Evaluation and Quality (OPEQ)
    • Office of Policy (OMP)
  • OPEQ evaluates medical devices for clinical or commercial use and is further divided into offices with specific oversight:
    • OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices
    • OHT2: Office of Cardiovascular Devices
    • OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices
    • OHT4: Office of Surgical and Infection Control Devices
    • OHT5: Office of Neurological and Physical Medicine Devices
    • OHT6: Office of Orthopedic Devices
    • OHT7: Office of In Vitro Diagnostics
    • OHT8: Office of Radiological Health
Combination Products
  • The Office of Combination Products (OCP) was established in 2002 to facilitate the assignment and registration of combination products.
  • OCP assigns a lead center (CDRH for devices or CDER for drugs) based on the primary mode of action of the combination product.
  • The lead center has primary jurisdiction but may consult with the OCP and other FDA centers.
In Vitro Diagnostics
  • Responsibility for evaluating IVDs is split between CDRH and CBER.
  • CDRH, specifically the Office of In Vitro Diagnostics (OHT7), regulates IVDs, except for tests used for blood donor screening.
  • Blood donor screening tests, such as HIV tests, are regulated by CBER.
Upcoming/Proposed Changes
  • The FDA has proposed a reorganization based on an evaluation by the Reagan-Udall Foundation and an internal review.
  • The reorganization includes an updated structure to enhance collaboration between the ORA and agency subject matter experts.
  • The ORA is proposed to be renamed the Office of Inspections and Investigations (OII).
  • Reorganization activities began on October 1, 2024, with the initiative announced in January 2023, intended for implementation within the 2024 calendar year.

Canada

  • Health Canada regulates products and health risks and consists of branches, offices, and bureaus, including the Office of Audit and Evaluation (OAE) and the Regulatory and Operations Enforcement Branch (ROEB).
  • The ROEB conducts compliance and enforcement activities, including field inspections and enforcement measures, and consists of eight directorates, each responsible for specific areas of expertise.
Medical Devices
  • The Medical Devices Directorate (MDD) regulates human use medical devices in Canada and includes six offices:
    • Director General's Office: Authorizes the sale of higher-risk medical devices and investigational testing.
    • Bureau of Licensing Services: Authorizes the sale of lower-risk medical devices.
    • Bureau of Investigation Testing Authorization, Special Access Program and Postmarket Surveillance: Evaluates the safety data of marketed medical devices and provides access to unlicensed medical devices in emergency situations.
    • Bureau of Evaluation: Reviews medical device applications for digital health devices, IVD devices, cardiovascular devices, musculoskeletal devices, and general and restorative devices.
    • Bureau of Planning and Operations: Develops procedures and training.
    • Bureau of Policy and International Programs: Develops and implements guidance documents and policies.
Combination Products
  • Historically, combination products had to comply with both the Canadian Medical Devices Regulations and the Canadian Food and Drug Regulations.
  • Medical devices were regulated by the MDD, and drugs by the Pharmaceutical Drugs Directorate (PDD, formerly referred to as the Therapeutic Products Directorate).
  • In 2006, Health Canada implemented an interim policy stating that a combination product will be subject to either medical device or drug regulations, depending on the principal mechanism of action.
  • The guidance document "Classification of Products at the Drug-Medical Device Interface" describes considerations for classification.
  • The Office of Science can provide a classification recommendation, with consultation from the Therapeutic Products Classification Committee (TPCC) as needed.
In Vitro Diagnostics
  • IVDs are subject to the Medical Devices Regulations and are overseen by the MDD.
  • The Bureau of Evaluation reviews applications for new and modified IVD devices.

Europe

European Union

  • Table 3-2 provides a list of National Competent Authorities (NCAs) for European Union (EU) countries.
Medical Devices
  • The European medical device regulatory framework is overseen by:
    • European Commission (EC) and its system of experts
    • Medical Device Coordination Group (MDCG)
    • Member States and their NCAs
    • Notified Bodies
  • The European Commission (EC) drafts regulations for medical device market access, with contributions from the European Parliament and Member States.
  • Member States enforce market surveillance of medical devices, combination products, and IVDs.
  • NCAs are appointed by Member States to address these responsibilities.
  • The Competent Authorities for Medical Devices (CAMD) project aims to enhance collaboration, improve market surveillance, and deliver better communication across the EU.
  • The EC and Member States cooperate via the MDCG, a group of experts that provides guidance and assistance in the implementation of medical device regulations.
  • Notified Bodies (Conformity Assessment Bodies - CABS) are private organizations designated by Member States to assess the conformity of products (including Medical Devices) with the General Safety and Performance Requirements set out in the EU Medical Device Regulation (MDR) and EU In Vitro Diagnostic regulation (IVDR).
  • CABs are notified to the EC by their respective Member States and are listed on the New Approach Notified and Designated Organizations (NANDO) website, each with an identification number.
  • As of October 2024, 50 notified bodies were able to certify under the MDR.
  • Team-NB is a collective notified body organization that promotes transparency and supports notified bodies across Europe, fostering continuous product improvement and patient access to safe and innovative devices.
  • Team-NB actively implements the new Medical Device and In-Vitro Diagnostic Regulations by creating and updating guidance documents, ensuring harmonized standards, encouraging innovation, and keeping members informed of regulatory updates.
  • Members of Team-NB benefit from access to Commission meetings, reports, and early updates, and are eligible for initiatives like the TCPII mutual agreement with Europe.
Combination Products
  • Medical devices intended for use with a medicinal product are called medical device and medicinal product combinations.
  • Manufacture of a medical device can fall within four regulatory scenarios, two of which are governed by the EU MDR:
    • When the medical device incorporates, as an integral part, a substance considered a medicinal product and the action of the medicinal substance is ancillary.
    • When the medical device is intended to administer a medicinal product and is not a single integral product.
  • Medical device and medicinal product combinations governed by the EU MDR are overseen by EC, MDCG, NCA and CABS, as well as the European Medicines Agency (EMA).
  • EMA supervises, scientifically evaluates, and monitors the safety of medicines and also evaluates certain medical devices, especially those with an integral medicinal product.
  • Under EU MDR, CAB can seek EMA's opinion on the quality, safety, and benefit-risk profile of the medicinal substance used in conjunction with a medical device. EMA provides its opinion within 210 days of receipt of all necessary documentation.
  • EMA also has a role with respect to substance-based devices (even if the device does not incorporate a medicinal product), when the EU MDR does not cover requirements on absorption, distribution, metabolism, excretion, local tolerance, toxicity, interaction with other devices, medicinal products or other substances, and potential for adverse reactions. EMA will provide an opinion on the compliance of the device with requirements laid down in Annex I to Directive 2001/83/EC relating to medicinal products for human use. This opinion will be drawn up within 150 days of receipt of all the necessary documentation.
In Vitro Diagnostics
  • The European IVD regulatory framework is governed by the same key regulatory agencies as in the medical device framework: EC, MDCG, Member States and NCAs, and CABS.
  • Table 3-3 provides a list of NCAs valid for both medical device and IVD registration under EU MDR and EU IVDR.
  • As of October 2024, there were 13 Notified Bodies able to certify under the EU IVDR.

Non-EU European Countries

  • Non-EU countries have different NCAs than the EU.
  • Major non-EU countries with their own rules for regulating medical devices, combination products, and IVDs are described below, and their NCAs are listed in Table 3-3.
Medical Devices
  • The EU medical device market Regulations (MDR and IVDR) apply to some European countries adopting EU legislation via different types of bilateral agreements.
  • The Mutual Recognition Agreement (MRA) is one of the key agreements between the EU and non-EU countries facilitating bilateral trade in several key sectors, including medical devices. This includes:
    • European Free Trade Association (EFTA) countries (Iceland, Liechtenstein, Norway)
    • Turkey
    • Micronations Andorra and Monaco
  • These countries have adopted CE (conformité européenne meaning European conformity) marking as the mutually recognized conformity assessment process for medical devices; however, each has its own competent authority and mandatory labeling or documentation language(s).
  • Russia:
    • Oversight of medical devices falls under Roszdravnadzor, which operates under the Ministry of Health of the Russian Federation and has three subordinate scientific expert institutions (FGBUS).
    • The Medical Device Registration and Control Department within Roszdravnadzor handles the registration of medical devices.
    • Entering the Russian market requires adherence to local laws and regulations.
    • Success in registering medical devices in Russia hinges on a comprehensive understanding of the regulatory framework.
    • The Medical Device Registration and Control Department makes decisions regarding the registration and denial of medical devices.
    • Roszdravnadzor:
      • Monitors the assortment and prices of vital and essential medicines.
      • Ensures the safety of medical devices.
      • Grants permits for importing and exporting substances.
      • Issues licenses for importing medical devices.
      • Provides opinions (permits) for importing and exporting samples of human biological materials.
      • Monitors the safe use and disposal of medical devices.
      • Ensures compliance with relevant legislation.
      • Conducts departmental and internal control of the quality and safety of medical activities at federal and regional levels.
      • Oversees the circulation of medicines, ensuring their quality, and implementing pharmacovigilance.
  • Switzerland:
    • The NCA is Swissmedic, which supervises and authorizes therapeutic and healthcare products.
    • The Law on Therapeutic Products regulates Swissmedic's activities.
    • Bilateral agreements between the EU and Switzerland determine compliance assessment and routes of certification.
    • Switzerland adheres to the EU system of compliance.
    • On 26 May 2021, the EU commission issued a notice to stakeholders on the status of the EU-Switzerland MRA for medical devices.
    • In the absence of a deal on the Institutional Framework Agreement, a full update of the MRA cannot be considered, including the MRA medical devices chapter.
    • The trade benefits provided by the MRA for medical devices, such as mutual recognition of conformity assessment results, elimination of the requirement for an authorized representative, and alignment of technical regulations, will no longer be in effect until a potential agreement on the proposed modification to the MRA is reached.
    • Swissmedic is responsible for the authorization market surveillance of medicinal products and medical devices.
    • Swissmedic collaborates both internationally and nationally with partner authorities and performs laboratory testing to help ensure the quality of authorized medicines and medical devices.
  • United Kingdom (UK):
    • The Medicines and Healthcare products Regulatory Agency (MHRA) regulates the use of medicines, medical devices, and blood components for transfusion in the UK.
    • The responsibilities of MHRA include ensuring that applicable standards are met with regards to product safety, quality and efficacy (effectiveness), as well as securing safe supply chains for the distribution of medicines, medical devices, and blood components.
    • The MHRA is also responsible for operating the UK medical device vigilance system.
    • Before a medical device can be placed on the UK market it must have a UK Conformity Assessed (UKCA) or CE certificate, that must be issued by an independent UK Approved Body.
    • MHRA does not certify medical devices but has oversight of UK Approved Bodies and can remove medical devices from the UK market if they are unsafe.
Combination Products
  • Combination products are regulated in each non-EU country based on the local legislative framework; regulatory authorities regulating these products are summarized in Table 3-4.
In Vitro Diagnostics
  • Each non-EU country has a local legislative framework regulating IVDs, which falls under the medical device umbrella; the regulation of IVDs is also overseen by the regulatory authorities summarized in Table 3-4.

Africa

  • Table 3-4 provides a list of select regulatory agencies for regulated markets in Africa.

Asia

  • Asia is a significant market for therapeutic products.
  • China and Japan are among the top five countries for global revenue from the sale of medical devices and pharmaceuticals.
  • Table 3-5 provides a list of select regulatory agencies for regulated markets in Asia.

China

Medical Devices
  • China's National Medical Products Administration (NMPA) was established in 2018 under the State Administration for Market Regulation, replacing the previous China Food and Drug Administration (CFDA).
  • NMPA oversees the safety, standards, registration, and quality management of medical devices.
  • NMPA has 21 affiliated institutions.
  • The Center for Medical Device Evaluation of NMPA (CMDE) handles the acceptance and technical review of domestically produced Class III medical devices and imported medical devices, as well as the filing of imported Class I medical devices.
  • CMDE has eight divisions to evaluate the registration of medical devices and IVDs:
    • Division 1: Active medical devices such as medical x-ray equipment
    • Division 2: Active medical devices, such as medical ultrasound equipment
    • Division 3: Non-active medical devices, such as cardiovascular and general surgical non-active implantable devices
    • Division 4: Non-active medical devices, such as orthopedic and dental non-active implantable medical devices
    • Division 5: Non-active medical devices, such as extracorporeal circulation devices and infusion devices
    • Division 6: Clinical laboratory instruments and IVD reagents
    • Clinical and Biostatistics Division 1: Clinical evaluation for medical devices
    • Clinical and Biostatistics Division 2: Clinical evaluation for IVDs
Combination Products
  • According to NMPA Announcement No. 52 of 2021, combination products are medical products composed of both drugs and medical devices, manufactured as a single entity.
  • Combination products that primarily function as drugs should be registered according to drug-related requirements, while those that primarily function as medical devices should be registered according to medical device-related requirements.
  • The Center for Drug Evaluation (CDE) leads the evaluation for combination products registered as drugs, while CMDE leads the evaluation for those registered as medical devices.
  • If a joint review is needed, the materials are shared by two centers for simultaneous review.
In Vitro Diagnostics
  • According to the Provisions for In-vitro Diagnostic Reagent Registration and Filing, IVD reagents refer to those managed as medical devices.
  • This includes reagents, reagent kits, calibrators, and quality control products used for the in vitro testing of human samples in the process of predicting, preventing, diagnosing, monitoring treatment, observing prognosis, and evaluating health status.
  • These products can be used alone or in combination with instruments, tools, equipment, or systems.
  • IVD reagents used for blood screening managed under drug regulations and those labeled with radioactive isotopes are not covered by the Provisions.
  • IVDs are reviewed and evaluated by CMDE Division 6 and Clinical and Biostatistics Division 2.

Japan

  • Medical devices, combination products, IVDs, and other device-related healthcare products are regulated by the Pharmaceuticals and Medical Devices Agency (PMDA), in partnership with the Ministry of Health, Labour and Welfare (MHLW).
Medical Devices
  • PMDA and MHLW work together to regulate medical devices.
  • The MHLW is responsible for administrative activities, including decisions regarding the designation of products as medical devices.
  • The PMDA is responsible for reviewing premarket applications and postmarket safety data for medical devices.
  • Japan classifies and regulates medical devices based on potential risk:
    • Low-risk devices can be self-certified and require submission to PMDA, but no formal review is conducted.
    • Moderate-risk devices require premarket certification, where the application is submitted to a Registered Certification Body (RCB) accredited by the MHLW.
    • High-risk devices are subject to a full premarket approval process, where an application is submitted to the PMDA for review, requiring ultimate approval of the MHLW.
Combination Products
  • In 2014, the PMDA published Handling of Marketing Application for Combination Products, which describes the handling of products that combine drugs and medical devices.
  • Combination products are assessed on an individual basis to determine a single applicable product category (medical device or drug).
  • Premarket applications are submitted to the PMDA for review under the designated product category.
  • In cases where it is difficult to determine the product category, consult with the MHLW's Evaluation and Licensing Division or Office of Medical Device/Cellular and Tissue-based Products.
In Vitro Diagnostics
  • Japan recognizes IVD reagents but not IVD devices.
  • A product designated as an IVD in other regions may be categorized as containing both a medical device and an IVD reagent in Japan.
  • IVD reagents undergo a classification process.
  • Based on the risk classification, the premarket application may be self-certified after filing with the PMDA, require RCB certification, or require premarket review by the PMDA and approval by the MHLW.
Upcoming/Proposed Changes
  • PMDA's Steering Committee announced that PMDA will open international offices for the first time in 2024.
  • The first overseas offices will be in the US and Southeast Asia and will include both PMDA government officials and local hires.

South Korea

  • The Ministry of Food and Drug Safety (MFDS), formerly known as the Korea Food and Drug Administration (KFDA), regulates medical devices in South Korea and also regulates drugs, food, and cosmetics, and oversees clinical trials.
  • The legal framework is based on the Medical Devices Act, the Enforcement Decree of the Medical Devices Act, and the Enforcement Regulations of the Medical Devices Act.
  • The Medical Devices Act regulates medical device manufacturing, distribution, and import to improve public health and ensure the efficient management of medical devices.
  • The Enforcement Decree of the Medical Devices Act is part of the legal framework that regulates medical devices.
  • The Enforcement Regulations of the Medical Devices Act outline the requirements for enforcing the Medical Devices Act and its Enforcement Decree.
  • The MFDS grants three types of market authorizations:
    • Premarket notification for medical devices with minimal potential risks.
    • Premarket certification or premarket approval for higher-risk classes.
  • Regulatory approval requirements include device approval and quality system certification (Korea Good Manufacturing Practices - KGMP), specified in the Medical Device Manufacturing and Quality Control Standards.
  • In addition to international test standards, the MFDS has local product standards and performance testing requirements.
  • Additional testing in South Korea may be required if existing test reports do not meet Korean requirements.
  • Companies without a physical presence in South Korea must appoint a Korea License Holder (KLH) as an in-country representative, acting as a liaison between the manufacturer and the MFDS.
  • Applications for product registration and K-GMP certification must be submitted through the KLH.

LATAM and the Caribbean

  • LATAM represents a broad geographic region including Central and South America, and the Caribbean.
  • Table 3-6 provides a list of select regulatory agencies for regulated markets in LATAM.
  • Steps are being taken to harmonize regulations across multiple markets.

Upcoming/Proposed/Recent Changes

  • Representatives from Mexico's COFEPRIS, Colombia's INVIMA, and Cuba's CECMED signed the Acapulco Declaration in April 2023.
  • The Acapulco Declaration is intended to establish a new regional regulatory group called the Latin America and Caribbean Medicines and Medical Devices Regulatory Agency (AMLAC) and harmonize regulations.
  • Argentina, Brazil, and Chile have declined to join the effort.

El Salvador

  • In El Salvador, the Dirección Nacional de Medicamentos (DNM) was responsible for the regulation of medical devices, medicines, and active pharmaceutical ingredients, as well as clinical trials.
  • Other types of regulated products, including veterinary products, were regulated by other agencies.
  • In late 2023, legislators announced the creation of a new regulatory agency called the Superintendencia de Regulación Sanitaria (Superintendency of Health Regulation, SRS).
  • The SRS began operating in 2024, consolidating the regulatory responsibilities of several agencies, including the DNM, and aligning El Salvador's regulatory infrastructure more closely with other major LATAM markets.

MENA

  • The acronym MENA refers to nations in the Middle East and North Africa.
  • Table 3-7 provides a list of select regulatory agencies for regulated markets in the MENA region.

United Arab Emirates (UAE)

  • In September 2023, the UAE established a new independent regulator called the Emirates Drug Corporation (EDC).
  • The EDC replaced the existing Regulatory Agencies (MOHAP) and has oversight for several regulated product types, including medical devices and pharmaceuticals.

Oceania

  • Oceania refers to nations in the central and South Pacific, the largest of which is Australia.
  • The primary regulated markets in the Oceania are Australia and New Zealand, as summarized in Table 3-8.

Australia

  • The TGA is responsible for the regulation of therapeutic goods, including medical devices, combination products, and IVDs.
  • The TGA is broken down into branches and divisions, including:
    • Medical Devices and Product Quality Division
    • Medicines Regulation Division
    • Regulatory Practice and Support Division
Medical Devices
  • The assessment, testing, and monitoring of medical devices fall within the responsibilities of the Medical Devices and Product Quality Division of the TGA.
Combination Products
  • The TGA defines regulatory pathways and requirements for therapeutic products based on the applicable product category (medicines, biologicals, medical devices, etc.), as defined in the Therapeutic Goods Act of 1989.
  • The TGA recognizes that some products may have attributes that fall into two or more product categories and defines such products as boundary products or combination products.
  • Boundary products are therapeutic goods that have some of the attributes of two or more categories of regulated goods and for which the appropriate regulatory pathway is not immediately obvious.
  • Combination products are products that contain more than one type of therapeutic good with more than one therapeutic action or effect, such as medical device/drug combinations, medical device/biological combinations, or drug/biologic combinations.
  • Version 2.0 of the guidance document Boundary and Combination Products Medicines, Medical Devices, and Biologicals was published in December 2023 and is intended to provide insight into how the TGA regulates boundary and combination products; it replaces guidance document Australia Medical Devices Guidelines: 35. Device-medicine Boundary Products.
  • Boundary devices are regulated by the TGA depending on the principal therapeutic effect of the product, the therapeutic claims, and the intended use of the product mentioned in product information and/or advertising materials.
  • Products which incorporate or administer medicinal substances may be regulated by the TGA as either medical devices or medicines (drugs).
  • Combination products are regulated based on the principal therapeutic effect for the product and may also consider factors such as therapeutic claims and intended use.
  • Device/drug combination products regulated by the TGA include:
    • Medical devices used to administer a drug which is provided separately.
    • Medicines co-packed with or contained within the same pack as medical devices.
    • Medical devices used for administering medicines where the medical device and drug form a single integral product.
  • These combination products are regulated by the TGA as either medical devices or medicinal (drug) products: medical devices are evaluated by the Medical Devices and Product Quality Division, and drugs are evaluated by the Medicines Regulation Division.
  • A list of examples of boundary products were published within examples of boundary and combination products and their product category.
  • In cases where the product category or regulatory pathway for a boundary or combination device is not clear, it is recommended to consult the TGA, which has separate email addresses for general information queries and those regarding the regulation of prescription drugs, medical devices, and over-the-counter-medicines.
In Vitro Diagnostics
  • The TGA defines IVDs as:
    • "Any medical device which is a reagent, calibrator, control material, kit, specimen receptacle, software, instrument, apparatus, equipment or system, whether used alone or in combination (with other diagnostic goods for in vitro use), intended by the manufacturer to be used in vitro for the examination of specimens derived from the human body, solely or principally for the purpose of giving information about a physiological or pathological state, a congenital abnormality or to determine safety and compatibility with a potential recipient or to monitor therapeutic measures".
  • The assessment of IVDs falls within the responsibilities of the Medical Devices and Product Quality Division of the TGA.

New Zealand

  • Medical devices, combination products, IVDs, and other device-related healthcare products are regulated by Medsafe, a business unit of the Ministry of Health.
  • Medsafe is a relatively small organization, comprised approximately of 60 staff, which are split into the following six groups:
    • Clinical Risk Management
    • Compliance Management
    • Product Regulations
    • Regulatory Practice and Analysis
    • Medicine Control
    • Operations.
Medical Devices
  • Medical devices are regulated by Medsafe, but there is currently no approval system for medical devices under the Medicines Act 1981.
  • Local manufacturers, importers, and exporters must notify non-exempt devices to the Web Assisted Notification of Devices (WAND) Database.
  • The database collects information on medical devices supplied to New Zealand, so Medsafe may monitor postmarket activity and contact sponsors in the event of a safety issue.
Combination Products
  • The Medicines Act 1981 includes definitions of medical devices and medicines (drugs) but does not define combination products.
  • The legal definition of medicines/drugs excludes medical devices, whereas the definition of medical devices excludes products that achieve their principal intended action by pharmacological, immunological or metabolic means but includes products which may be assisted in their function by such means.
  • Although combination products are not strictly defined by Medsafe, the authority does regulate both medical devices and drug products.
  • It is recommended that specific questions on combination products be directed to Medsafe, which has separate email addresses for general information queries, and medical device or WAND related queries.
In Vitro Diagnostics
  • IVDs are subject to regulation in New Zealand.
  • Per the Medicines (Database of Medical Devices) Regulations 2003, they are not currently required to be notified to the WAND database.

Conclusion

  • This chapter has delved into the global regulatory landscape, highlighting the crucial role played by regulatory agencies across different regions of the world in guaranteeing the safety, efficacy, and regulatory conformity of medical devices, combination products, and IVDs.
  • Each authority, spanning North America to Oceania, bears the crucial duty of protecting public health through rigorous oversight of development, marketing approval, and postmarket surveillance.
  • Despite the variety in their methodologies and standards, these regulatory entities share a common goal to maintain the utmost levels of safety and efficiency in medical devices, combination products, and IVDs.
  • This united effort not only contributes to enhancing global health but also drives the innovation of medical technologies to address the changing healthcare needs of populations around the globe.