Contents. Regulatory Bodies... 13

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2 Contents UNITED STATES... 3 Regulatory Bodies... 3 Product Classification and Regulatory Control... 3 Application Documents... 3 Quality System Requirements... 4 Product and Manufacturer s License... 4 Registration Steps... 4 EUROPEAN UNION... 5 Regulatory Bodies... 5 Product Classification and Regulatory Control... 5 Medical Devices Directive... 5 Application Documents... 5 Quality System Requirements... 6 Product and Manufacturer s License... 6 Registration Steps... 6 CHINA... 7 Regulatory Bodies... 7 Product Classification and Regulatory Control... 7 Application Documents... 7 Quality System Requirements... 7 Product and Manufacturer s License... 8 Application Steps... 8 JAPAN... 9 Regulatory bodies... 9 Product Classification and Regulatory Control... 9 Application Documents... 9 Quality System Requirements Product and Manufacturer s License Application Steps (for Class II device only) SOUTH KOREA Regulatory Bodies Product Classification and Regulatory Control Application Documents Quality System Requirements Product and Manufacturer s License Application Steps MALAYSIA Regulatory Bodies Product Classification & Regulatory Control Application Documents Quality System Requirements Product and Manufacturer s License Application Steps Page1

3 BRAZIL Regulatory Bodies Product Classification & Regulatory Control Application Documents Quality System Requirements Product and Manufacturer License Application Steps CANADA Regulatory body Product Classification and Regulatory Control Application Documents Quality System Requirements Product and Manufacturer s License Application Steps Page2

4 Regulatory Bodies UNITED STATES Food and Drug Administration (FDA): The US FDA is the governmental authority that regulates medical device products intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease intended to affect the structure or any function of the body of humans or other animals. Center for Devices and Radiological Health (CDRH) is responsible for regulating firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States. In addition, CDRH regulates radiation-emitting electronic products (medical and non-medical) such as lasers, x- ray systems, ultrasound equipment, microwave ovens and color televisions. Product Classification and Regulatory Control There are approximately 1700 generic types of devices and are grouped under 16 medical specialties referred to as panels. Each of these generic types of devices is assigned to one of three regulatory classes based on the level of control necessary to assure the safety and effectiveness of the device. A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to premarket approval. PMA is the most stringent type of device marketing application required by FDA. The applicant must receive FDA approval of its PMA application prior to marketing the device. Application Documents Medical Device User Fee Cover Sheet (Form FDA 3601) CDRH Premarket Review Submission Cover Sheet 510(k) Cover Letter Indications for Use Statement 510(k) Summary or 510(k) Statement Truthful and Accuracy Statement Class III Summary and Certification Financial Certification DOC and Summary Reports Executive Summary Device Description Substantial Equivalence Discussion Proposed Labeling Sterilization and Shelf Life Biocompatibility Software EMC and Electrical Safety Performance Testing - Bench Performance Testing - Animal Performance Testing - Clinical Page3

5 Quality System Requirements There is not always a requirement to have the QMS audited prior to sale in the US. Devices that need a 510k do not need an FDA audit prior to market clearance. The manufacturer should be prepared for an FDA quality system inspection at any time after market clearance. Devices that need a premarket approval will mostly require an FDA audit (site inspection) prior to sale. Product and Manufacturer s License Both 510k premarket notification and Premarket Approval do not expire. Establishment Registration (License Holder) All manufacturers are required to register their establishment and list the devices prior to commercialization. Register annually with FDA between October 1st and December 31st of each year. Required to list the devices that are made there and the activities that are performed on those devices. Local Agent Must either reside in the U.S and assist FDA in communications with the foreign establishment. No responsibility related to reporting of adverse events under the Medical Device Reporting regulation or submitting 510(k) Premarket Notifications Registration Steps Upon market clearance, manufacturers are required to list their product under a registered establishment. Page4

6 Regulatory Bodies EUROPEAN UNION In Europe, medical devices are required to be CE-marked through an EC Notified Body (a conformity assessment body designated by the EC) before commercialization. Each Notified Body has its own set of review scope, and there is often a choice of registration route for manufacturers. For some Europe countries, manufacturer are required to go through additional registration or regulatory processes in order to receive market clearance for their CE-marked products. Additional Registration Required France (AFSSAPS) Germany (DIMDI) Italy (MOH-NSIS) Ireland (IMB) Spain (AEMPS) Netherland (CIBG) for IVDs only No Additional Registration Required Austria Belgium Bulgaria Czech Republic Demark Finland Greece Poland Portugal United Kingdom Product Classification and Regulatory Control There are three separate Medical Devices Directives covering medical devices: Implantable medical devices directive (AIMD) Medical devices directive (MDD) In vitro diagnostic medical devices directive (IVDD) Medical Devices Directive Application Documents Part A Name of Manufacturer Quality System Information of Manufacturer Device Summary Classification and Applied Rules List of Applicable Standards and Guidelines Page5

7 Part B Detailed Product Information Essential Requirements Risk Analysis Product and Quality Assurance Sterilization Aseptic Filling Documentation of Quality System Packaging Qualification, Shelf Life and Logistics Product Labeling, Instruction for Use Technical and Mechanical Investigation Microbiological Investigation Preclinical Investigation Device Incorporating Medical Substance Device Incorporating Non-Viable Materials of Animal Origin Device Incorporating Phthalates Device with Measuring Function Clinical Evaluation Quality System Requirements EN ISO 13485:2012 is the harmonized standard for quality systems compliance under Directive 93/42/EEC Notified Body requires an audit of the QMS before certification and CE marking (except Annex IV -EC Verification) Product and Manufacturer s License License Holder There are no medical device licenses required in the EU. Approved product will have a CE certificate issued by the notified body, which is normally valid for 3 years. However, notification of the first placing on the market to the competent authorities are required in some EU states. (Germany-DIMDI, Italy-DGMMD, France-AFSSAPS) Local Agent Manufacturers outside the EU have to appoint an authorized representative within the EU. The AR name and address must appear with the manufacturer s name and address on the product label. Registration Steps Page6

8 Regulatory Bodies CHINA The China Food and Drug Administration (CFDA) is responsible for supervision and administration of medical devices in China. It is the governmental authority that issues Medical Device registration Certificate for foreign manufacturers. Foreign manufacturers must submit their applications to the national office of CFDA located in Beijing. Product Classification and Regulatory Control There are 3 product classes under the current CFDA product classification system. The criteria for classification is based on its structural characteristics, form of operation and conditions of use. For foreign manufacturers, there is no much difference for class II and class III products in term of submission requirements except that the review time for class III products may take longer than class II products. Application Documents 1. Manufacturer s License 2. Marketing Approval from Country of Origin 3. Authorization Letter to Legal Representative Agent 4. Declaration Letter of Authenticity 5. Electrical Safety Test Report (IEC or IEC ) 6. Authorization Letter to a. Authorization to Registration Agent b. Authorization to Prepare Standard c. Appointment of After-Sales Agent 7. Declaration Letter a. Confirmation of Identical Standards b. Guarantee of Quality c. Commitment of Legal Representative Agent d. Commitment of After-Sales Agent e. Declaration of Test Report f. Clinical Report Declaration 8. Product Standard 9. Product Manual 10. Clinical Trial Report 11. Software Validation Report 12. Raw Material Manual 13. Invitation letter for quality system audit (for implant products only) 14. Specification, Industry Standards & Test Report 15. Business License of Registration Agent 16. Business License of Legal Representative 17. Business License of After Sales Agent 18. Application Form Quality System Requirements The manufacturing site must demonstrate compliance to ISO 13485, US FDA QSR or equivalent certification from the home country. Oversea audit is highly unlikely to happen due to budget concerns. Page7

9 Product and Manufacturer s License License holder The license is under the name of the overseas manufacturing site. The license issued will be valid for 4 years and product renewal process is very similar to a new application. Registration Agent: To coordinate and control CFDA registration. Any local company or person residing in China. Legal Agent: Report any adverse events regarding the medical device that occurs inside or outside China to SFDA. Handle any recall incidences in China if they arise After Sales Agent: Provide technical service and maintenance support, which must be included in the business scope of the business license Application Steps Page8

10 Regulatory bodies JAPAN Ministry of Health, Labor and Welfare (MHLW) A cabinet level ministry of the Japanese government provides regulation on drugs, medical devices and cosmetics Pharmaceuticals and Medical Devices Agency (PMDA): An Independent administrative agency under MHLW and is responsible for the scientific review of medical device for marketing authorization Registered Certification Body (RCB) There are currently 13 RCBs providing 3 rd party review on behalf of PMDA Product Classification and Regulatory Control Application Documents Page9

11 Quality System Requirements The manufacturing site of the imported products must demonstrate compliance to QMS (Quality Management System) ordinance No.169 which is based on ISO 13485:2003, with some deviations. For class I, no inspection applies. For class II under RCB review, inspection will be by a RCB. For all other class II as well as all of classes III and IV, inspection will be conducted by the PMDA. An inspection is a mandatory part of a new medical device application. QMS approval expires after five years, and the manufacturer must apply for renewal six months before expiration. Product and Manufacturer s License Product Class I medical devices require a device notification Class II medical devices require a device certificate Class III and IV medical device require a device approval. Product license does not expire. Local Company The local license holder must have a license for Marketing Authorization Holder (MAH) or Designated Marketing Authorisation Holder (DMAH). Overseas Manufacturer Foreign medical device manufacturers do not need a MAH license themselves, or a license for manufacture. Foreign manufacturers need to register their company. The application for registration shall be completed by the foreign manufacturing facility, but a DMAH could apply on behalf of the foreign facility. Application Steps (for a Class II device only) Page10

12 Regulatory Bodies SOUTH KOREA The Ministry of Food and Drug Safety (MFDS) is the government agency responsible for promoting the public health by ensuring the safety and efficiency of foods, pharmaceuticals, medical devices and cosmetics in South Korea. There are currently six 3 rd party reviewing authority for the class II device Product Classification and Regulatory Control Class SE Review Type Review Body GMP License Type IV N SER MFDS HQ P Approval IV Y TDR MFDS HQ P Approval III N SER MFDS HQ P Approval III Y TDR MFDS HQ P Approval II N SER Regional MFDS P Approval II Y TDR 3rd Party P Approval II Notified Products 10-day review Regional MFDS P Approval I - - E-Listing O Notification Note: SE Substantial Equivalency Having a similar product available on the market Application Documents Document Required TDR SER Intended Use P P Operation Principle P P Electrical/Mechanical Safety P P Biological Safety P P Sterility Data P P Radiation Safety P P EMC P P Performance data P P Physical/Chemical characteristics P P Stability data P P Clinical Evaluation & Investigation P Origin or grounds for discovery and development P Use in other countries P Note: General Technical Document Review (TDR) - For products that are basically the same as an approved product in the market and is able to show substantial equivalence Safety and efficacy review (SER) - For products that are different from those currently available on the market (New structure, new performance, new intended use, or innovative concept) Quality System Requirements All Medical Devices are required to be manufactured under GMP. Premarket GMP audit is mandatory for all class II, III and IV devices.. Certification of compliance to Standards for manufacturing and quality management of Medical Devices (KGMP, similar to ISO 13485) Page11

13 Both document review and site inspection are conducted by 3rd party GMP inspector organization accompanied by KFDA officer For company with multiple manufacturing sites, only one of the highest class site will be sampled. The other sites will be evaluated by off-site document review. Product and Manufacturer s License Product All Class II, III and IV devices require a device license without no expiry date. The registered product could be placed on the market with a valid KGMP certificate. Local License Holder With the phasing out GIP license, foreign firm could now have their representative office in Korea as the license holder. Quality System A KGMP certificate will be issued after a successful audit (on-site audit or document review). The certificate will be valid for 3 years. Application Steps Page12

14 Regulatory Bodies MALAYSIA Medical Device Authority - reviews & registers product & licenses establishment 3 rd party conformity assessment body review evidence of conformity Product Classification & Regulatory Control Source: Medical Device Control Division, Ministry Of Health Malaysia Page13

15 Application Documents Declaration of conformity (DOC) An attestation that each device complies with the appropriate EPSP. Information sufficient to identify the device The risk class allocated to the device The type of conformity assessment elements applied The date from which the DOC is valid The name and address of the device manufacturer The name, position and signature of the responsible person ASEAN CSDT Executive Summary Relevant essential principles for Safety and Performance (EPSP) and method used to demonstrate conformity Device description Summary of design verification and validation documents Device labelling Risk analysis Manufacturer information Page14

16 Quality System Requirements Manufacturers of Class C and D devices should have a full quality management system that includes design and development. Manufacturers of Class B devices should have a quality management system also; however, the procedures incorporated within it may not include design and development activities. Manufacturers of Class A devices are expected to have the basic elements of a QMS in place but need not include design and development activities. For Class B, C and D devices, the MDB or CAB needs to be satisfied that the manufacturer has an effective quality management system in place, appropriate for the device under assessment. In doing this, the MDB or CAB will consider any relevant existing certification and, if not satisfied, e.g. with its scope or with post-market performance history, may carry out an on-site audit of the manufacturer s facility. Product and Manufacturer s License Product License The product license has to be applied by a qualified establishment, which is valid for 5 years Establishment License An establishment could be a manufacturer, importer, distributor or an authorized representative appointed by a foreign manufacturer. Application Steps Page15

17 Regulatory Bodies BRAZIL ANVISA National Health Surveillance Agency regulates medical devices, cosmetic, drugs, and food. IMMETRO National Institute of Metrology, Quality and Technology responsible for certification schemes ANVISA performs all registration and inspection functions within the agency. Product Classification & Regulatory Control There are 4 product classes which correspond to European MDD classes using the same risk classification and rules. Documentation required are almost the same for 4 classes except on GMP. Application Documents A copy of payment bank receipt provided by ANVISA. Free sales certificate (it can be replaced by the INMETRO certificate when applicable) Certificate of Good Manufacturing Practice (GMP) Instructions manual in Portuguese Labeling and packaging A copy of authorization of the manufacturer to import and commercialize its medical device Clinical trials or information A declaration of conformity INMETRO certification, when applicable Quality System Requirements Good manufacturing practice (GMP) certification, based on an inspection conducted by ANVISA, is required for registration (RDC No. 25, May 21, 2009). The GMP certificate must be submitted with the registration application for all Class III and IV devices, as well as for Class I and II devices on the exemption list. The GMP certificate is valid for two years, and ANVISA alone determines whether subsequent evaluations can be completed remotely through a paperwork audit. Product and Manufacturer License All foreign manufacturers must have a local distributor or representative. All devices, with a few exceptions, must be registered with ANVISA. The product license is valid for 5 years. Application Steps Page16

18 Regulatory body CANADA Therapeutic Products Directorate, Health Canada Product Classification and Regulatory Control Similar product classification as EU MDD Class I Medical Device Establishment License; Class II-IV Medical Device License; Only Class III & IV require documentation review Application Documents Device classification Device name & Description Application history Name and Address of Manufacturer as it appears on the device label Mailing address for Regulatory Correspondence License Application Type Intended use List of Standards Complied with in the Manufacture of the Device (Only class II) Attestation of Safety and Effectiveness (Only class II) Attestation of labeling (Only class II) Attestation of investigational testing for IVDDs (Only class II) Evidence of safety and effectiveness (Class III and IV) Attestation of drug safety, efficacy and quality Signature Quality System Requirements Manufacturer must provide to Health Canada a valid certification of Quality System Requirements by Accredited CMDCAS Registrar before issuance of Device License Class I Not required; Class II IV CAN/CSA ISO excluding design The CMDCAS certificate is valid for 3 years with annual surveillance Product and Manufacturer s License Foreign manufacturers are not required to use local authorized representatives (ARs). Registered products will be posted on Health Canada website. Application Steps Page17

19 Prepared on 11 Jan, 2014 Copyright Notice: This document is proprietary to Veecare Asia and should not be reproduced without permission. Disclaimer: This document is provided for informational purposes only and is not intended to convey any legal advice. Page18

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