Importing and Exporting Medical Devices: A Primer on Regulatory Strategy and Requirements

Why Should You Attend:

Any medical device that is legally in the U.S. may be exported anywhere in the world without prior FDA notification or approval. The export provisions under section 802 of the FD&C Act only apply to unapproved devices. But all medical devices that are imported into the U.S. must meet Bureau of Customs and Border Protection (CBP) requirements in addition to FDA. Product that does not meet FDA regulatory requirements may be detained upon entry.

Devices that have not been approved or cleared in the U.S. must follow the export provisions of the FD&C Act. Foreign firms that manufacture medical devices and/or products that emit radiation that are imported into the United States must comply with applicable U.S. regulations before, during, and after importing into the U.S. or its territories. For exporting, while FDA does not place any restrictions on the export of devices, certain countries may require written certification that a firm or its devices are in compliance with U.S. law. In such instances FDA will accommodate U.S. firms by providing a Certificate for Foreign Government (CFG).

This Webinar will provide an overview of the requirements and expectations and an introduction to the regulations, including 21 CFR 1, Subpart E--Imports and Exports. We will discuss the documentation process and the record keeping requirements. This webinar will provide direction and guidance to device companies involved in importing and exporting of medical devices.

Areas Covered in the Seminar:

• Examine the import and export requirements for medical devices.
• Introduction to FDA references and guidance documents related to import and export requirements.
• Understand the regulatory process if you are a foreign manufacturer or initial importer and want to sell your device in the U.S.
• Import Alerts.
• Recordkeeping requirements and your responsibilities.
• How to export unapproved and approved medical devices.

Who Will Benefit:

This webinar will provide direction and guidance to device companies involved in importing and exporting of medical devices.
All levels of management and departmental representatives and those who desire a better understanding or a "refresh" overview of the export/import process, including:

• QA and Compliance
• Regulatory Affairs
• Marketing/Sales
• Consultants
• International Distributors/Authorized Representatives

Instructor Profile:

David R. Dills, Independent Regulatory & Compliance Consultant, with an accomplished record has more than 22 years of hands-on experience with emphasis on Class I/II/III medical devices, In Vitro diagnostics, and pharmaceuticals in the areas of QA, Regulatory Affairs and Compliance. Since 2000, has provided consultative services on behalf of global manufacturers and subcontracted by third-party consultancies and provides services involving all key stages of the product development, submission, and commercialization process, inspection readiness preparation, GxP compliance, execute audits and regulatory assessments, execute remediation and regulatory strategies, postmarketing surveillance/vigilance reporting, clinical affairs, deploy and remediate QMS and documentation systems, preparation for ISO 13485 registration and CE Mark, and multi-country device registrations. He has been previously employed, with increasing responsibilities by medical device firms and consultancies, including a globally recognized CRO.

Mr. Dills manages quality, regulatory and compliance projects with multiple competing priorities having a direct impact on site operations/commercial opportunities. Develops strategies for governmental approval to introduce new products to market, provides “hands-on” guidance on regulatory requirements, and constructs and reviews drug and device submissions [e.g., 510(k), PMA, IDE), and dossiers/technical files, including applications/registrations for the Pacific Rim, The Americas and EU, and involved in establishing and deploying QA systems with emphasis on preventing the design, manufacture, and shipment of defective products. Manages QS and regulatory problems (e.g. adverse events, MDRs, Agency enforcement and complaints) related to development, manufacturing, and commercialization, and recommends action to senior leadership to ensure effective resolution for manufacturers to achieve sustainable and proven compliant systems. Background encompasses broad capabilities in quality systems and regulatory affairs, validation, and interfaces with FDA and other governmental agencies on the global landscape, MDD/IVDD Directives, ICH, ISO 14971 and 13485, and demonstrates credible experience to maximize performance and optimizes business performance through proactive strategies to mitigate compliance exposure. Develops strategies and adds business value to manufacturers by providing strategic and tactical solutions that facilitate the achievement of regulatory and quality milestones and on minimizing delays due to noncompliance.

Mr. Dills has served on the Faculty Advisory Board for the Pharmaceutical Training Institute and currently serves on the Editorial Advisory Boards for Software Quality Professional and the Institute of Validation Technology (IVT), publisher of the Journal of GXP Compliance and Journal of Validation Technology and on the Readers’ Board for Medical Device & Diagnostic Industry and Medical Product Manufacturing News and was nominated and accepted for inclusion into the 2005-2006 Strathmore’s Who’s Who of Professionals. Mr. Dills has authored and published validation, regulatory and compliance-related articles, commentaries and technical guides, and is an accomplished global industry presenter. Mr. Dills’ academic degrees include Environmental Science and Biology. He is a former Chair and Co-Chair of ASQ’s Section 1506 and an active member of the Biomedical Division, RAPS, PDA, ISPE, and other industry working groups.

Topic Background:

SEC. 802. [21 USC §382] Exports of Certain Unapproved Products

• (a) A drug or device—
  • (1) which, in the case of a drug—
    • (A) (i) requires approval by the Secretary under section 505 before such drug may be introduced or delivered for introduction into interstate commerce; or
    • (ii) requires licensing by the Secretary under section 351 of the Public Health Service Act or by the Secretary of Agriculture under the Act of March 4, 1913 (known as the Virus-Serum Toxin Act) before it may be introduced or delivered for introduction into interstate commerce;
    • (B) does not have such approval or license; and (C) is not exempt from such sections or Act; and
  • (2) which, in the case of a device—
  • (A) does not comply with an applicable requirement under section 514 or 515;
  • (B) under section 520(g) is exempt from either such section; or
  • (C) is a banned device under section 516, is adulterated, misbranded, and in violation of such sections or Act unless the export of the drug or device is, except as provided in subsection (f), authorized under subsection (b), (c), (d), or (e) or section 801(e)(2). If 1 a drug or device described in paragraphs (1) and (2) may be exported under subsection (b) and if an application for such drug or device under section 505 or 515 or section 351 of the Public Health Service Act was disapproved, the Secretary shall notify the appropriate public health official of the country to which such drug will be exported of such disapproval.
• (b) (1)(A) A drug or device described in subsection (a) may be exported to any country, if the drug or device complies with the laws of that country and has valid marketing authorization by the appropriate authority—
• (i) in Australia, Canada, Israel, Japan, New Zealand, Switzerland, or South Africa; or
• (ii) in the European Union or a country in the European Economic Area (the countries in the European Union and the European Free Trade Association) if the drug or device is marketed in that country or the drug or device is authorized for general marketing in the European Economic Area.
• (B) The Secretary may designate an additional country to be included in the list of countries described in clauses (i) and (ii) of subparagraph (A) if all of the following requirements are met in such country:
• (i) Statutory or regulatory requirements which require the review of drugs and devices for safety and effectiveness by an entity of the government of such country and which authorize the approval of only those drugs and devices which have been determined to be safe and effective by experts employed by or acting on behalf of such entity and qualified by scientific training and experience to evaluate the safety and effectiveness of drugs and devices on the basis of adequate and well-controlled investigations, including clinical investigations, conducted by experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs and devices.
• (ii) Statutory or regulatory requirements that the methods used in, and the facilities and controls used for—
  • (I) the manufacture, processing, and packing of drugs in the country are adequate to preserve their identity, quality, purity, and strength; and
  • (II) the manufacture, preproduction design validation, packing, storage, and installation of a device are adequate to assure that the device will be safe and effective.
• (iii) Statutory or regulatory requirements for the reporting of adverse reactions to drugs and devices and procedures to withdraw approval and remove drugs and devices found not to be safe or effective.
• (iv) Statutory or regulatory requirements that the labeling and promotion of drugs and devices must be in accordance with the approval of the drug or device.
• (v) The valid marketing authorization system in such country or countries is equivalent to the systems in the countries described in clauses (i) and (ii) of subparagraph (A).
• The Secretary shall not delegate the authority granted under this subparagraph.
• (C) An appropriate country official, manufacturer, or exporter may request the Secretary to take action under subparagraph (B) to designate an additional country or countries to be added to the list of countries described in clauses (i) and (ii) of subparagraph (A) by submitting documentation to the Secretary in support of such designation. Any person other than a country requesting such designation shall include, along with the request, a letter from the country indicating the desire of such country to be designated.
• (2) A drug described in subsection (a) may be directly exported to a country which is not listed in clause (i) or (ii) of paragraph (1)(A) if—
• (A) the drug complies with the laws of that country and has valid marketing authorization by the responsible authority in that country; and
• (B) the Secretary determines that all of the following requirements are met in that country:
  • (i) Statutory or regulatory requirements which require the review of drugs for safety and effectiveness by an entity of the government of such country and which authorize the approval of only those drugs which have been determined to be safe and effective by experts employed by or acting on behalf of such entity and qualified by scientific training and experience to evaluate the safety and effectiveness of drugs on the basis of adequate and well-controlled investigations, including clinical investigations, conducted by experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs.
  • (ii) Statutory or regulatory requirements that the methods used in, and the facilities and controls used for the manufacture, processing, and packing of drugs in the country are adequate to preserve their identity, quality, purity, and strength.
  • (iii) Statutory or regulatory requirements for the reporting of adverse reactions to drugs and procedures to withdraw approval and remove drugs found not to be safe or effective.
  • (iv) Statutory or regulatory requirements that the labeling and promotion of drugs must be in accordance with the approval of the drug.
• (3) The exporter of a drug described in subsection (a) which would not meet the conditions for approval under this Act or conditions for approval of a country described in clause (i) or (ii) of paragraph (1)(A) may petition the Secretary for authorization to export such drug to a country which is not described in clause (i) or (ii) of paragraph (1)(A) or which is not described in paragraph (2). The Secretary shall permit such export if—
• (A) the person exporting the drug—
• (i) certifies that the drug would not meet the conditions for approval under this Act or the conditions for approval of a country described in clause (i) or (ii) of paragraph (1)(A); and
• (ii) provides the Secretary with credible scientific evidence, acceptable to the Secretary, that the drug would be safe and effective under the conditions of use in the country to which it is being exported; and
• (B) the appropriate health authority in the country to which the drug is being exported—
• (i) requests approval of the export of the drug to such country;
• (ii) certifies that the health authority understands that the drug is not approved under this Act or in a country described in clause (i) or (ii) of paragraph (1)(A); and
• (iii) concurs that the scientific evidence provided pursuant to subparagraph (A) is credible scientific evidence that the drug would be reasonably safe and effective in such country.
• The Secretary shall take action on a request for export of a drug under this paragraph within 60 days of receiving such request.
• (c) A drug or device intended for investigational use in any country described in clause (i) or (ii) of subsection (b)(1)(A) may be exported in accordance with the laws of that country and shall be exempt from regulation under section 505(i) or 520(g).
• (d) A drug or device intended for formulation, filling, packaging, labeling, or further processing in anticipation of market authorization in any country described in clause (i) or (ii) of subsection (b)(1)(A) may be exported for use in accordance with the laws of that country.
• (e)(1) A drug or device which is used in the diagnosis, prevention, or treatment of a tropical disease or another disease not of significant prevalence in the United States and which does not otherwise qualify for export under this section shall, upon approval of an application, be permitted to be exported if the Secretary finds that the drug or device will not expose patients in such country to an unreasonable risk of illness or injury and the probable benefit to health from the use of the drug or device (under conditions of use prescribed, recommended, or suggested in the labeling or proposed labeling of the drug or device) outweighs the risk of injury or illness from its use, taking into account the probable risks and benefits of currently available drug or device treatment.
• (2) The holder of an approved application for the export of a drug or device under this subsection shall report to the Secretary—
• (A) the receipt of any credible information indicating that the drug or device is being or may have been exported from a country for which the Secretary made a finding under paragraph (1)(A) to a country for which the Secretary cannot make such a finding; and
• (B) the receipt of any information indicating adverse reactions to such drug.
• (3)(A) If the Secretary determines that—
  • (i) a drug or device for which an application is approved under paragraph (1) does not continue to meet the requirements of such paragraph; or
  • (ii) the holder of an approved application under paragraph (1) has not made the report required by paragraph (2), the Secretary may, after providing the holder of the application an opportunity for an informal hearing, withdraw the approved application.
• (B) If the Secretary determines that the holder of an approved application under paragraph (1) or an importer is exporting a drug or device from the United States to an importer and such importer is exporting the drug or device to a country for which the Secretary cannot make a finding under paragraph (1) and such export presents an imminent hazard, the Secretary shall immediately prohibit the export of the drug or device to such importer, provide the person exporting the drug or device from the United States prompt notice of the prohibition, and afford such person an opportunity for an expedited hearing.
• (f) A drug or device may not be exported under this section—
  • (1) if the drug or device is not manufactured, processed, packaged, and held in substantial conformity with current good manufacturing practice requirements or does not meet international standards as certified by an international standards organization recognized by the Secretary;
  • (2) if the drug or device is adulterated under clause (1), (2)(A), or (3) of section 501(a) or subsection (c) or (d) of section 501;
  • (3) if the requirements of subparagraphs (A) through (D) of section 801(e)(1) have not been met;
  • (4)(A) if the drug or device is the subject of a notice by the Secretary or the Secretary of Agriculture of a determination that the probability of reimportation of the exported drug or device would present an imminent hazard to the public health and safety of the United States and the only means of limiting the hazard is to prohibit the export of the drug or device; or
  • (B) if the drug or device presents an imminent hazard to the public health of the country to which the drug or device would be exported;
  • (5) if the labeling of the drug or device is not—
• (A) in accordance with the requirements and conditions for use in—
  • (i) the country in which the drug or device received valid marketing authorization under subsection (b); and
  • (ii) the country to which the drug or device would be exported; and
• (B) in the language and units of measurement of the country to which the drug or device would be exported or in the language designated by such country; or
• (6) if the drug or device is not promoted in accordance with the labeling requirements set forth in paragraph (5).

In making a finding under paragraph (4)(B), (5), or (6) the Secretary shall consult with the appropriate public health official in the affected country.

• (g) The exporter of a drug or device exported under subsection (b)(1) shall provide a simple notification to the Secretary identifying the drug or device when the exporter first begins to export such drug or device to any country listed in clause (i) or (ii) of subsection (b)(1)(A). When an exporter of a drug or device first begins to export a drug or device to a country which is not listed in clause (i) or (ii) of subsection (b)(1)A) 2 , the exporter shall provide a simple notification to the Secretary identifying the drug or device and the country to which such drug or device is being exported. Any exporter of a drug or device shall maintain records of all drugs or devices exported and the countries to which they were exported.
• (h) For purposes of this section—
• (1) a reference to the Secretary shall in the case of a biological product which is required to be licensed under the Act of March 4, 1913 (37 Stat. 832–833) (commonly known as the Virus-Serum Toxin Act) be considered to be a reference to the Secretary of Agriculture, and
• (2) the term "drug" includes drugs for human use as well as biologicals under section 351 of the Public Health Service Act or the Act of March 4, 1913 (37 Stat. 832–833) (commonly known as the Virus-Serum Toxin Act).
• (i) Insulin and antibiotic drugs may be exported without regard to the requirements in this section if the insulin and antibiotic drugs meet the requirements of section 801(e)(1).

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