Procedure for registration of Medical Devices

[Procedure] Procedure for registration of Medical Devices for manufacture and import into Bangladesh All Medical Devices of Class B, C and D, as per the below mentioned classification shall be registered before they are imported or manufactured into the country. 1. Application for registration of Medical devices which are already being importedor manufactured into the countryshall be made immediately from the issue of this guideline. 2. For Medical Devices which are to be imported or manufacturedfor the first time, the applicant has to apply for registration before such importor manufacture. 3. The application for registration has to be made by alocal authorized person of the manufacturer or foreign supplier or authorized agent to the DGDA. Procedure for application. 1. Application for registration of a Medical Devices shall be made by theauthorizedperson orlocal authorized agentof the manufacturer, or foreign supplier in the prescribed form to the office of the DGDA. 2. Prescribed fees of Taka _______ shall be paid along with the application. 3. Separate application and fees are to be paid for separate applications, separate manufacturing premises and separate products. Similar type of Medical Devices if manufactured in the same premises can be applied in the same application form (Example – All Stents – Similar type, All Intra Ocular Lenses – Similar type, All Catheters – Similar type, All Orthopaedic Implants – Similar type, All Sutures – Similar type etc.). However an application shall not have more than 5 products and for more than5 products separate applications shall be made. (To consider company placing product as a manufacturer) Details to be submitted in the application 1. Name, address, telephone number and email of the local authorised agent, 2. Authorisation letter, in original, from the manufacturer authorising the local agent to be the applicant. This will not be required if the application is made by the manufacturers own office in Bangladesh. 3. Name, address, telephone number and email id of the company/person responsible for placing the product in the market, if not the same as the manufacturer. Certified by a company’s legally authorised person. 4. Details of the local manufacturer in case part processing is planned to be carried out in Bangladesh.(Exclusivity for local part manufacture and which part of manufacture considered as “Manufacturer” status) Product Details 1. Name of the Device, including brand name and generic name, if any. 2. Device Class as per GHTF classification, 3. Device details and description, 4. Device sizes, 5. Principle use of the device, 6. Device Master File, (required only in cases where the CE/US FDA approvals are not available) should include material of construction and details of quantitative analysis, if required 7. Short description of the manufacturing process. Multi-facility manufacturing details may be given,( Brief description of manufacturing process and accompanied with flow diagram) 8. Labelling and Packaging details, 9. Details of accessories required for using the product,if applicable 10. Details of any predicate/ substantially equivalent product, if applicable, 11. Standard of the product,(Prevailing International standards like ISO(International Organization for Standardization)/ASTM(American Society for Testing and Materials)/IEC(International Electrotechnical Commission)/AAMI(Association for Advancement of Medical Instrumentation) 12. Device user’s manual /Direction for use , e labeling if any (Example : e Instruction For Use ) (IFU),) Marketing and Regulatory details 1. Regulatory status in the country of manufacture and in other developed economies : (a) For class B Devices, FSC from country of origin, (b) For class C and D Medical Devices , FSC from any one of the countries – EU, USA, Canada,Australia and Japan and FSC from country of origin. (c) Conformityassessment certificate or equivalent certificate has to be submitted. 2. List of countries where the device is marketed, 3. Details regarding any withdrawal / market recall initiated by the regulatory authority fromthe market for any reasons in the last two years, Combination devices 1. The medical benefits of Drug-device combination products should be described in detail. 2. Drugs which are incorporated with the device and have action ancillary to device, data on the drug’s safety has to be given, 3. Clinical trial data of devices containing new drugs have to be submitted. ( Refer New Drug definition under Drug Act and Rules Bangladesh and make amendment if necessary) Sales and post marketing process details : 1. Sales, Service and Distribution model details of the product, ( Example : Direct marketing/ Channel partners; Service support etc), procedure by applicant/ manufacturer 2. Post Marketing : Adverse report handling, Field Action , product recalls including re-export of the product and complaint management procedure by applicant/ manufacturer [Device category] Medical device list: DEFIBRILLATOR Keyword | Therapeutic code | category | Description ADAPTOR | 74 | B | CABLE AND ADAPTER, DEFIBRILLATOR CABLE | 74 | B | CABLE AND ADAPTER, DEFIBRILLATOR DEFIBRILLATOR | 74 | C | DC-DEFIBRILLATOR, HIGH ENERGY, (INCLUDING PADDLES) DEFIBRILLATOR, BATTERY POWERED DEFIBRILLATOR, TRANSTELEPHONIC DEFIBRILLATOR/MONITOR, BATTERY POWERED DEFIBRILLATOR/MONITOR, LINE POWERED DEFIBRILLATOR | 74 | D | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, EXTERNAL, AUTOMATIC LEAD, ELECTRODE, CARDIOVERTER, DEFIBRILLATOR, PERMANENT PAD | 74 | B | PAD, DEFIBRILLATOR PADDLE PADDLE | 74 | B | PADDLE, PAD, ELECTRODE, DEFIBRILLATOR (EXTERNAL) PATCH | 74 | D | LEAD, ELECTRODE, CARDIOVERTER, DEFIBRILLATOR Note: Need to take permission for B, C and D [Annex-3 ] Annexure-3 Application checklist for permission for Manufacture & import of Medical devices Complete application has to fill in clear manner. If any data is not relevant and applicable,please enter N/A (not applicable) . Annex details wherever required. SL No | Details | comments | Supporting Documents 1 | Name, address and communication details of the Manufacturer /Agent in Bangladesh 2 | Authorisation letter of the Authorised Agent 3 | Name address and communication details of the manufacturer 4 | Are the products already imported in Bangladesh, if so since when 5 | Name of the product, including its generic name, if any 6 | Device class and classification system followed. Attached conformity assessment certificate. 7 | Details of the Conformatory Assessment body 8 | Since how long the device is being used commercially? Has clinical evaluation and safety issues been addressed for the device? 9 | Principle use of the device 10 | Is it a drug-device combination? 11 | If the above is “yes”, is the drug a new drug 12 | Is it a kit comprising of more than one device? 13 | Sizes of the device 14 | Is Device Master File submitted 15 | Short description of the Manufacturing process 16 | Procedure for sterilization 17 | Procedure for release of the Device in the market 18 | Name and qualifications of technical personnel for manufacture and quality assurance 19 | Layout plan of the premises accompanied by the floor plan. 20 | Details of QMS and manual 21 | Is the product tested before release, if yes, submit details; if no, specify criteria for release 22 | Has the product been withdrawn due to any reasons? If yes please specify. 23 | Recall procedure to be followed in case the product has to be withdrawn 24 | Names of the countries where the device is exported. Note: Please answer the above question and attached the supporting documents. Need to apply along with the information of Annex 3.