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- 2. CONCLUSION Schedule 2: FEES & LICENCING Schedule 4: DOCUMENTATION Regulatory of MD & IVD in India Asia Regulatory & Quality Consultancy for Medical Device & Drug Schedule 1: CLASSIFICATION Overview: Schedule 1: Classification Schedule 2: Fees & Licencing Schedule 3: Notified bodies Schedule 4: Documentation Schedule 5: QMS for MD and IVD Schedule 6: Post Approval Changes Schedule 7: Clinical Investigation Schedule 8: Exemptions Schedule 3: NOTIFIED BODIES
- 3. CONCLUSIONSchedule 1: CLASSIFICATION Regulatory of MD & IVD in India Asia Regulatory & Quality Consultancy for Medical Device & Drug Class A Class B Class C Class D e.g. Bolster suture, Umbilical occlusion devices, Pharynscope, etc. e.g. Forceps, Angioscopes, Contact lenses, etc. e.g. Surgical dressings, Wound dressings, Condoms e.g. Vascular clips, Cerebrospinal catheter, Pulmonary artery band Medical devices shall be notified by the Central Government and classified by the CLA based on the classification rules specified in the First Schedule of the drafted rules. Schedule 3: NOTIFIED BODIES Schedule 4: DOCUMENTATION Schedule 2: FEES & LICENCING
- 4. CONCLUSION Schedule 2: FEES & LICENCING Regulatory of MD & IVD in India Asia Regulatory & Quality Consultancy for Medical Device & Drug Schedule 1: CLASSIFICATION Schedule 3: NOTIFIED BODIES Schedule 4: DOCUMENTATION Activity Device Class Class A Class B Class C Class D Import CLA CLA CLA CLA Manufacture SLA SLA CLA CLA Permission to conduct clinical investigation Permission from CLA Sale SLA QMS Verification Notified Body1,2 Notified Body2 CLA CLA 1Prior inspection shall not be required before the grant of manufacturing of Class A devices. 2Notified Bodies shall be registered with CLA and shall be audited by CLA. Device Class Activity
- 5. CONCLUSION Schedule 2: FEES & LICENCING Regulatory of MD & IVD in India Asia Regulatory & Quality Consultancy for Medical Device & Drug Schedule 1: CLASSIFICATION Schedule 3: NOTIFIED BODIES Schedule 4: DOCUMENTATION Activity Device Class Class A Class B Class C Class D Import Import Licence Import Licence Import Licence Import Licence Manufacture Manufacturing Licence1 Manufacturing Licence Manufacturing Licence Manufacturing Licence CLINICAL INVESTIGATION FOR investigational DEVICES and new IVDs For an Investigational medical device, the applicant shall need to obtain Permission from CLA to conduct clinical investigation of Class B, Class C and Class D And Clinical Performance Evaluation of new IVDs Sale Regulation as per current C & D rules QMS Verification Notified Body1 Notified Body2 CLA CLA 1Prior inspection shall not be required before the grant of manufacturing of Class A devices. 2Notified Bodies shall be registered with CLA and shall be audited by CLA. Device Class Activity
- 6. CONCLUSION Schedule 2: FEES & LICENCING Regulatory of MD & IVD in India Asia Regulatory & Quality Consultancy for Medical Device & Drug Schedule 1: CLASSIFICATION Schedule 3: NOTIFIED BODIES Schedule 4: DOCUMENTATION For Import and Manufacturing Licences For Class A: USD$1000 (site) USD$50 (each distinct medical device) For Class B: USD$2000 (site) USD$1000 (each distinct medical device) For Class C & D: USD$3000 (site) USD$1500 (each distinct medical device) Medical Devices In-vitro Devices For Class A & B: USD$1000 (site) USD$10 (each distinct IVD) For Class C & D: USD$3000 (site) USD$500 (each distinct IVD)
- 7. CONCLUSION Schedule 2: FEES & LICENCING Regulatory of MD & IVD in India Schedule 1: CLASSIFICATION Schedule 3: NOTIFIED BODIES Schedule 4: DOCUMENTATION Asia Regulatory & Quality Consultancy for Medical Device & Drug Notified Bodies • Need to be registered with CDSCO • Accredited by a National Accredited Body (Such as NABCB) • Schedule fee is to be charged by notified bodies • Registration of notified bodies are prescribed in Schedules
- 8. CONCLUSION Schedule 2: FEES & LICENCING Regulatory of MD & IVD in India Schedule 1: CLASSIFICATION Schedule 3: NOTIFIED BODIES Schedule 4: DOCUMENTATION Asia Regulatory & Quality Consultancy for Medical Device & Drug Only for class A & B MDs/IVDs Notified body responsibilities: QMS Conformance at manufacturing site where necessary by inspection Verify Essential Requirements Validation of Manufacturing Process through objective evidence Conformity of material with defined specifications *SLA to audit 2% of audits carried out and recommended for grant of license by of each Notified Body
- 9. Technical documents needed Class A Class B, C & D • Device master file as specified in Appendix II & III of Part III of Fourth Schedule. • Test licence obtained for testing and generation of quality control data (for domestic manufacturers only), if any; • Copy of performance evaluation report issued by the central medical device testing laboratory or medical device testing laboratory registered under sub - rule (3) of rule 83 CONCLUSION Schedule 2: FEES & LICENCING Regulatory of MD & IVD in India Schedule 1: CLASSIFICATION Schedule 3: NOTIFIED BODIES Schedule 4: DOCUMENTATION Asia Regulatory & Quality Consultancy for Medical Device & Drug • Device description, intended use of device, specification including variants and accessories; • Summary of working principle, analytical technology, relevant analytes and test procedure; • Labels and package inserts (IFU, etc.,), user manual, wherever applicable; • Analytical performance summary including sensitivity and specificity;
- 10. CONCLUSION Schedule 2: FEES & LICENCING Regulatory of MD & IVD in India Schedule 1: CLASSIFICATION Schedule 3: NOTIFIED BODIES Schedule 4: DOCUMENTATION Asia Regulatory & Quality Consultancy for Medical Device & Drug Things to note about Import Licence: Validity of Licence – remain valid in perpetuity unless it is suspended or cancelled or surrendered. In case of New IVD, applicant shall obtain prior permission to import in Form MD – 29 as per Rule 64. Fresh application is required in case of constitution change. Timeline: 9 months Licence is issued in MD-15 MD-15
- 11. CONCLUSION Schedule 2: FEES & LICENCING Regulatory of MD & IVD in India Schedule 1: CLASSIFICATION Schedule 3: NOTIFIED BODIES Schedule 4: DOCUMENTATION Asia Regulatory & Quality Consultancy for Medical Device & Drug Medical Devices with predicate devices Animal Performance study data IVD with predicate devices or non-notified IVDs Only 1, 3, 5, 7 and 8 Design Analysis data Bio-compatibility tests data Risk Management Data 1 2 3 4
- 12. CONCLUSION Schedule 2: FEES & LICENCING Regulatory of MD & IVD in India Schedule 1: CLASSIFICATION Schedule 3: NOTIFIED BODIES Schedule 4: DOCUMENTATION Pilot/Pivotal Clinical Investigation data Regulatory status & Restriction on use in other countries (if any) where marketed or approved Proposed Instruction for use and labels. Medical Devices with predicate devices Information/supporting data of the waiver from clinical investigation is claimed in accordance with the provisions of Medical Device Rules 2017 5 6 7 8 IVD with predicate devices or non-notified IVDs Only 1, 3, 5, 7 and 8 CONCLUSION Schedule 2: FEES & LICENCING Regulatory of MD & IVD in India Schedule 1: CLASSIFICATION Schedule 3: NOTIFIED BODIES Schedule 4: DOCUMENTATION Asia Regulatory & Quality Consultancy for Medical Device & Drug
- 13. Plant master file (PMF)/Power of Attorney (POA) • Site master file (Annex V) • Registration certificate and/or import licence for import of drugs in India (Annex III) CONCLUSION Schedule 2: FEES & LICENCING Regulatory of MD & IVD in India Schedule 1: CLASSIFICATION Schedule 3: NOTIFIED BODIES Schedule 4: DOCUMENTATION Asia Regulatory & Quality Consultancy for Medical Device & Drug General Info. More information in the CDSCO guidance document Personnel Premises Equipment Sanitations Documentations Production Quality Control Loan Licence Manufacture & Licensee Distribution Self-Inspection Distribution Annexes
- 14. Schedule 2: FEES & LICENCING Regulatory of MD & IVD in India Schedule 1: CLASSIFICATION Schedule 3: NOTIFIED BODIES Schedule 4: DOCUMENTATION Asia Regulatory & Quality Consultancy for Medical Device & Drug CONCLUSION Summary • Split up into 8 “Schedules” • Medical Devices(MD)/In Vitro Devices(IVD) and classified into 4 categories A, B, C and D • Different classes of MD/IVD have require varying degrees of permissions from different authorities • Class A and B are able to be handled by notified bodies • Technical Documents differ for each class of MD/IVD
- 15. Schedule 2: FEES & LICENCING Regulatory of MD & IVD in India Schedule 1: CLASSIFICATION Schedule 3: NOTIFIED BODIES Schedule 4: DOCUMENTATION CONCLUSION Contact us for details info@arqon.com www.arqon.com Our Services: Asia Regulatory & Quality Consultancy for Medical Device & Drug
Notas del editor
- Regulatory affairs for medical devices and in-vitro devices in India goes through a process of different “Schedules”. Each schedule determining a different part of the regulatory framework, ultimately going through 8 schedules and obtaining product approval in the end. We will be going through the more important parts of these schedules, namely, the first 4 schedules. Classification, Fees and Licencing, Notified Bodies and Documentation
- In the first schedule, India’s classification of medical devices and in-vitro diagnostic devices have a very specific scope as can be seen here in the example. The types of medical devices are specified in the CDSCO document and put into the 4 classes A, B, C and D. The reasoning behind the classes are the severity of risk of each device. With class A having the lowest risk, and class D having the highest risk. Any medical device or in-vitro device not specified in CDSCO’s list is considered non-notified and a different procedure, which we will go through later is required.
- Currently, the different classes of medical devices or in-vitro devices are being handled by various authorities. All import licences are issues through the CLA or the Central Licensing Authority, while Manufacturing licences are issued by the SLA or State licensing authority, for Class A and Class B, while CLA issues manufacturing licenses for Class C and Class D. Permission from CLA is required to conduct clinical investigations, while Sale licences are controlled by the SLA. For the quality management system verifications, CLA will perform the audits for Class C and Class D, while Notified bodies will be able to handle Class A and Class B. A special case being given to Class A medical devices and IVDs, where prior inspection will not be required before the grant of manufacturing of Class A devices.
- Next is the new PROPOSED system. This is only slightly different in that Class A Manufacturing licences can be issued without prior inspections, and permission is not needed for clinical investigation for Class A devices.
- Moving on to the next “Schedule”, the fees for each import and manufacturing licence are as follows. For medical devices, the licence fees are different depending on their class, with Class A being the cheapest and Class C & D being the most expensive. Take note that the prices for a site and each distinctly different medical device are different. For IVDs, the price range is similar to the MDs with A & B being cheaper than C & D as well.
- Having notified bodies will speed the process of registration along. Companies like us, ARQon, that are registered and accredited by the relevant authorities will help with the registration of the devices. Some other things to note are that the schedule fee is to be charged by notified bodies and if you require more information, registration of notified bodies are prescribed in the schedules.
- Some responsibilities that a notified body can assist with are that they are able to verify the following processes and documents. Including QMS conformance through inspection, Essential requirements for the relevant regulations, Validation of manufacturing process and conformity of material. To ensure that the notified bodies are performing to standard, the SLA is also to audit 2 percent of the audits
- Next, on the next schedule, the Documentation required for registration to obtain the import licence. All of the required documents can be found in the official file from the CDSCO website. We will only be focusing on the differences in documents required for Class A devices and Class B, C and D devices. Seen here, is are the documents that are needed for each category, that the other category lacks. The main idea here is that the higher classes as compared to Class A require more in-depth and thorough documents. An example is shown where Class A only requires a device description, intended use, and specification, the higher classes require a device master file. Or that only an analytical performance summary is required of Class A devices, higher classes require a copy of the performance evaluation report.
- Some things to note about the import licence. The licence is issued in MD-15, and the rough timeline is 9 months to obtain the licence. The validity of the licence will remain valid in perpetuity unless suspended or cancelled or surrendered. In the case of New IVD, the applicant shall obtain prior permission to import in Form MD-29 as per Rule 64. Also, if there is a constitution change, a fresh application is required.
- In the case where the medical device to register has a predicate device, these here are the 8 documents to be submitted together with the application for the import or manufacturing licence. For IVDs, only number 1, 3, 5 ,7 and 8 are required if the IVD has a predicate device or if the IVD is non-notified. “What about non-notified medical devices?”, you might ask. If the device is not in the extensive list, and is not under the “Drugs” category, it is not a regulated device in India.
- Additional documents are the Plant master file, or PMF and the Power of Attorney, or POA documents. If you are familiar with a site master file, a plant master file is almost the same set of documents needed. Documents such as general information about the site, personnel, premises, equipment, et cetera. For the full list of documents needed, refer to the medical device rules 2017 from the CDSCO website in Schedule 4: Part III, Appendix 1. For the Power of Attorney documents, It is required for issue of registration certificate and/or import license for import of drugs in India. Similarly, for more information, see the medical device rules 2017 from CDSCO website in Schedule 4: Part I.
- To end this presentation, I shall provide a summary. The regulatory process for India for MD and IVD registration is split up into 8 distinct schedules. The devices are classified into 4 categories: A, B, C and D. Devices in Class A has the lowest risk assessment, while devices in Class D has the highest. As can be seen in the table previously, each Class require varying degrees of permission from different authorities, depending on the licences they require, where Class A and B are can be handled by accredited and registered Notified bodies. The technical documents required for each class of MD/IVD also differ.
- If you require more information on what was just presented, you can contact us at info@arqon.com, or visit www.arqon.com for more information on the various Medical Device registration processes. If you are interested in what we do, go to our website and learn more about our services. We are also active on LinkedIn and twitter. Be sure to follow us to get regular updates on the regulatory and quality affairs on Medical devices.