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MEDICAL DEVICE REGULATIONS.pptx
- 1. MEDICAL DEVICE REGULATIONS M RPradeep M.Pharm Deputy Drugs Controller (Retired) 1 12/22/2022
- 2. TRAINING PROGRAMME • Forthe Technical Experts of • DYNAMIC TECHNO MEDICALS • ON 29/03/2018 , 10.30 am to 01.00 pm. • SUB: An over view of the Medical Device Regulation Rules 2017 & its Practical implementation in Quality improvement • Venue: Kodikuthimala,Edathala,Aluva. 2 12/22/2022
- 3. DYNAMIC TECHNO MEDICALS •PRODUCTS UNDER MD LICENCE • Class A • Surgical dressings • Orthopaedic appliances • Compression stickings • Sports supports • Rehabilitation aids • Silicon foot care products etc 3 12/22/2022
- 4. CLASS B,C &D PRODUCTS • B- CASTING TAPE-different types • C-SUTURES • D-SILICON DRESSINGS 4 12/22/2022
- 5. MDR 2017 • MDRules 2017 vide GSR 78(E) dated 31/01/17 came into force w e f 01/01/2018 • Applicable for Sub:used for In Vitro Diagnosis and Surgical dressings, Surgical bandages, Surgical staples, Surgical sutures, ligatures,blood and blood component collection bag with or without anticoagulant ,covered under sub clause (i) • Sub: including mechanical contraceptives, • disinfectants and insecticides notified usc (ii) & devices notified usc (iv) of S.3(b) of the Act 5 12/22/2022
- 6. Need for Regulations •To ensure safety, efficacy, quality and performance of Drugs & Medical Devices • To regulate the import, export, manufacturing, • sales, stock, distribution & safety of Drugs, Cosmetics, Biological and Medical devices to protect public health. • Regulations must be effective and uniform. • The mechanism must act efficiently & speedily 6 12/22/2022
- 7. M D NOTIFIEDAS DRUGS from 3/89 • Disposable Syringes • Disposable Needles • Disposable perfusion sets • 3 items in 17-3-89 • IVDD for HIV, HBsAg & HCV in 27-8-2002 • Ablation Devices in 25-01-06 7 12/22/2022
- 8. Sterile Devices underDrugs w e f 06-10-2005 • Cardiac stents • Drug eluting stents • Catheters • Intraocular lens • I V cannula • Bone cements • Heart valves • Scalp vein set • Orthopaedic implants • Internal prosthetic replacements 8 12/22/2022
- 9. MD NOTIFIED ASDRUGS • 15 MD are now under notified drugs. • 12 more after Medical Device Rules 2017 • NEBULISERS • B P MONITORS • DIGITAL THERMOMETERS • GLUCOMETERS • w e f 01-01-2020 9 12/22/2022
- 10. NOTIFIED MD ASDRUGS • IMPLANTABLE MD • MRI EQUIPMENT • CT SCAN EQUIPMENT • DEFIBRILLATORS • DIALYSIS MACHINES • PET EQUIPMENT • X-RAY MACHINES • BONE MARROW CELL SEPARATOR 10 12/22/2022
- 11. MD UNDER DPCOLIST • OUT OF 27 MDs,5 DEVICES ONLY are under NLEM list & under price Control • CARDIAC STENTS • DRUG ELUTING STENTS • CONDOMS • INTRA UTERINE DEVICES • ORTHOPAEDIC KNEE IMPLANTS 11 12/22/2022
- 12. MANUFACTURING OF AMD • Any process or part of process for making, assembling, altering, ornamenting, finishing, packing, labelling or adapting any MD with a view to its sale or stock or export or distribution, • but does not include assembling or adapting a device already on the market for an individual patient as directed by a RMP 12 12/22/2022
- 13. SOME DEFINITIONS-CHAPTER I •Long term use- • use of a MD for more than 30 days • Short term use- • use for 60 min to 30 days • Transient use- use for less than 60 min • Change in constitution- proprietorship to partnership or LLP or vice versa. From private to public company or vice versa. Change in ownership of 51% of shares of company 13 12/22/2022
- 14. DIFFERENCE BETWEEN DRUG • Discoverydominates • Safety & Efficacy • (chemical Action) • Clinical trials (4 phases) • (randomized, gold std) • All drugs need CT • GMP • Local & systemic toxicity • Long product life cycle • Drug Interactions MEDICAL DEVICE • Design Dominates ( Engg) • Safety & Performance • (Physical action) • Clinical evaluation • ( No gold Standard) • Low, medium &high risk • QMS • Biocompatibility • Short product life cycle • Device Malfunction 14 12/22/2022
- 15. CHAPTER 2. CLASSIFICATION •MD other than IVD MD are classified in Part I of the First Schedule, • IVDMD in Part II of the schedule • 1.Low risk - Class A • 2.Low Moderate Risk - Class B • 3.Moderate High Risk - Class C • 4. High Risk - Class D • Class wise list published in cdsco website 15 12/22/2022
- 16. GROUPING • Application tobe submitted for • Import purpose • Manufacture for sale or distribution • Sale, stock, exhibit or offer for sale • The manufacturer shall follow the principles of safety & performance, updating contemporary scientific & technological knowledge & development with Govt Guidelines. 16 12/22/2022
- 17. PRODUCT STANDARDS • Conformto BIS Specifications • U/s 3 of BIS Act.1985 • GOI Notifications • ISO Standards • IEC( International Electro Technical Commission) • Pharmacopoeial Standards • Validated, Manufacturers Standards 17 12/22/2022
- 18. CHAPTER 3- LICENSING AUTHORITIES •CLA • Import of all classes of MD • Manufacture of Class C,D • Clinical investigation & approval of investigational MD • Clinical performance evaluation & approval of new IVDMD & coordination with SLA • SLA for manufacture for A,B & sale of ALL. 18 12/22/2022
- 19. NATIONAL ACCREDITATION BODY • TheCG by notification, designate a NAB • Certification Body for Notified Bodies • Will assess the NB & issue Qualification Certificate or reject their application. • Prepare standards for accreditation by NB • Prepare norms & procedures for NBs • Audit the NB periodically for conformity 19 12/22/2022
- 20. NOTIFIED BODY • Applyto NAB for accreditation • NB carry out audit of mfg sites for A&B as advised by SLA.NB must register with CLA. • NB with min 2 yrs exp. may apply for C & D • Apply in Form MD-1 online to CLA for Regn • CLA issue a Reg, Certificate in Form MD-2 valid for 5 yrs. • NB can act through a Qualified person also. 20 12/22/2022
- 21. TESTING LABORATORIES • 1.N I B – Noida for IVD HIV, HBsAg, HCV, blood grouping sera, Glucose strips etc • 2. CDTL Chennai for Condoms • 3. CDL, Kolkata for surgical dressings, bandages, cotton, disinfectants etc. • 4. RDTL, Gowhati for Disposable syringes, needles, Ivcannula, perfusion sets etc. • 5. DCTL,Mumbai for IUD & Falope rings 21 12/22/2022
- 22. OFFICERS ENTRUSTED • MedicalDevice Testing Officer S-20 by CLA • Medical Device Officer u/s-21 by CLA&SLA • Testing of MD • Central MD TL for testing & evaluation of MD • Appellate Lab approved by CDSCO • All labs must be NABL Certified for Testing MD 22 12/22/2022
- 23. • CHAPTER 4 Mfreof MD/IVDMD For Class A/B fees Rs 5000/-+Rs 500/-per MD Apply to SLA Through online portal of MOHFW Form MD-3 for Lic/Form MD-4 for LL Grant Class A in Form MD-5/MD-6 for LL Only document verification for Class A& Audit by NB, within 120 days of grant of MDL by SLA. For Class B, audit by NB within 90 days. 23 12/22/2022
- 24. FOR CLASS C& D • Apply through online portal to CLA • Apply in Form MD-7 & MD-8 (LL). • CLA may use services of an expert for scrutinising the appln & related documents. • The scrutiny must be completed within 45 days of receipt& inspect the firm with experts. • CLA can take the services of NB also. • Fees Rs 50000/-for site Rs 1000/- per MD 24 12/22/2022
- 25. REQUIREMENTS FOR GRANT •Must comply QMS specifications • Must have employed qualified & experienced competent TS(2 yrs exp after Degree) for mfg and testing of MD. To be inspected within 60 days of appln. with two MDO (one Sr) with or without experts, or a NB. For licensed firms inspection is not mandatory for additions.IR to be submitted to CLA with copy to applicant. within 45 days of IR grant the lic in Form MD-9 / Form MD-10 (for LL) 25 12/22/2022
- 26. APPLICATION DOCUMENTS • CLASSA • Device description • Intended use of device • Specs including variants & accessories • Material of construction • Labels, package insert, user manual • Summary of ADR • SMF • Signed undertaking agreement • Essential principles check list • Analytical performance check list etc 26 12/22/2022
- 27. DOCUMENTS contd • Constitutiondetails of Mfrer • SMF • Device Master File • Essential Principles Check list • Test Lic for testing &generation of QC data • Signed Undertaking agreement of compliance • In vitro performance evaluation report for IVD 27 12/22/2022
- 28. APPLICATION CATEGORIES • Single,Family, IVD test kit, System, IVD Cluster & Group • Single – sold as a distinct pack • Licensed separately • Part of a group must be licensed separately • Group – combination assembled together as one pack, as in first aid kit. 28 12/22/2022
- 29. CONDITIONS OF LICENCE •Lic. shall be produced on request by MDO • Shall inform any occurrence of suspected/unexpected/serious/adverse event and action taken including recall within 15 days of the notice of licensee to SLA/CLA • Licensee shall obtain prior approval from CLA/SLA before making any major changes in the MD, within 45 days. 29 12/22/2022
- 30. CONDITIONS contd • Minorchanges to be reported within 30 days • Must test each batch before release • Must keep an audit/inspection book in MD-11 • Must keep 1 ref sample for 180 days after exp. • Must keep mfg, testing & sales records • Must accompany user manual/package insert • Mfg &testing to be done with TS only • Closure/stoppage of mfg for 30 days more must be informed to SLA/CLA 30 12/22/2022
- 31. LICENSEES TO KNOW •During change in constitution of the firm inform the SLA/CLA within 45 days & obtain MDL within 180 days • Lic is valid for 5 yrs.Can apply late up to 180 days with payment of retention fee. • Licensee must withdraw the MD found to be non conforming to specifications from the market under intimation to CLA/SLA. 31 12/22/2022
- 32. RESPONSIBILITIES OF THE Mfrer •Must determine the classification • Intended purpose • Appropriate MD nomenclature code • Select & apply appropriate conformity assessment procedures to demonstrate with the essential principles • All documents connected with the design, production or intended performance of the MD must be updated. 32 12/22/2022
- 33. TEST LICENSE CONDITIONS •Small quantities of MD can be Mfd for clinical Investigation, test evaluation, examination, demonstration or training by submitting in Form MD-12 to CLA with fees, along with • Brief description of the MD with intended use, material of construction, design stating the list of equipments, instruments, qualified TS, copy of Mfg Lic. and approval letter authorizing to undertake R&D activities issued by any G O. 33 12/22/2022
- 34. TEST LICENCE CONDITIONS •Test lic in Form MD-13 by CLA within 30 days • The Licensee shall keep records of mfg • Valid for 3 yrs from date of issue. Fee 500/- per item. • The MD must be used only for clinical investigation ,test, evaluation, demonstration and training purpose. The licensee shall keep • Records of mfg ,testing and stock of the MD & The MDO must verify them during inspection 34 12/22/2022
- 35. IMPORT OF MD-CHAPTER V • Apply in Form MD-14 to CLA by a licensee • Grant lic in Form MD-15 within 9 months, after document verification and inspection • For investigational MD or new IVDMD prior permission in Form MD-27/MD-29 from CLA needed • VALID FOR 5 YRS • For personal use, with invoice & prescription 35 12/22/2022
- 36. LABELLING - CHAPTER6 • Must be labeled with • Name of the MD with its quantity /packing • Batch no, mfg date/sterilization date ,exp date • Name & address of the manufacturer • Mention that MD contains medicinal/biological substance& give storage/handling condition • Warning / precaution indication, usage as single use, sterile state & method used etc 36 12/22/2022
- 37. LABELLING CONDITIONS • ImportedMD must contain import lic.no., • Name & address of importer, address of the mfg premises and mfg date as sticker • For export,the law of that country&code no • W e f 01-01-22, MD must bear a unique identification no for device & production- global trade item no & batch no & exp date • Exp date is up to 5 yrs from mfg date 37 12/22/2022
- 38. DUTIES OF MD O • Inspect NLT once in a year • Conform that the lic. conditions are complied • Take samples for test & to send to MDTL • Maintain record of inspection, sampling, prosecution • Conduct enquiries ,investigations and to institute prosecution actions • Review technical dossier of MD 38 12/22/2022
- 39. AUDIT PROCEDURES • TechnicalReview of Documents • On- site Audit of the mfrers QMS • Checking of SOPs with reality • Check the competency of the TS • Establish design conformity to ensure its quality, safety and performance • Check post approval changes • Assess conformity to the product & process 39 12/22/2022
- 40. APPLICATION DOCUMENTS • CONSTITUTIONDETAILS OF THE FIRM • S/PMF • DEVICE MASTER FILE • ESSENTIAL PRINCIPLES CHECK LIST • TEST LIC: FOR GENERATING Q C DATA • OWNERSHIP DOCUMENTS • BUILDING PLAN • DETAILS OF MDs TO BE MANUFACTURED • DETAILS OF COMPETENT T Ss ETC 40 12/22/2022
- 41. SITE/ PLANT MASTERFILE • General information • Brief information on the site, location, • Address, mfg activities, type of devices mfd, details of employees in production, QC, ware housing & distribution. • External assistance taken in QA • QMS details, testing protocols • Devices registered in foreign countries 41 12/22/2022
- 42. PERSONNEL & PREMISES •Organizational chart with Qualification,exp & responsibilities of key personnels • Training schedule, medical exam& records • Personal hygiene details & clothing • Layout, fittings and HVAC system details • Ancillary areas- water, maintainance,ETP, • sterilization facilities, area for handling toxic/hazardous materials 42 12/22/2022
- 43. PRODUCTION • Production flowcharts & processes • Handling of starting materials,packaging, • bulk & finished products including sampling, quarantine,release and storage • Handling of rejected goods & reprocessing • Process validation, sterilization facilities • QA system& release procedures ,storage • documentation,complaints handling,audits 43 12/22/2022
- 44. Q M S •The manufacturer shall establish, document, implement & maintain a QMS & maintain its effectiveness • Processes needed include processes for management activities, provision of resources, product realization & measurement. 44 12/22/2022
- 45. ESSENTIAL DOCUMENTS • Statementof Quality policy& objectives • Quality manual • Documented procedures • Documents required to ensure effective planning, operation & process controls • Records required by QMS • Prepare a Device Master File document • Electronic data recording is allowed 45 12/22/2022
- 46. QUALITY MANUAL • WithScope of the QMS • Documented procedures/references • Structure of the documentation • Prepare a Site/Plant Master File about the manufacturing activities with premises & facilities, personnel, equipment, Sanitation, Production, • Quality Assurance, Storage, Documentation, • Medical device complaints & field safety Corrective action, Internal audits, Contract activities 46 12/22/2022
- 47. MANAGEMENT REVIEWS • Auditreports • Customer feedback • Process performance & product conformity • Status of CAPA • Follow up actions from previous reviews • Changes that could affect QMS • Recommendations of improvement • New or revised regulatory requirements 47 12/22/2022
- 48. PREVENTIVE ACTION • Eliminatethe causes of non conformities to prevent their occurrence • A documented procedure is established for determining potential non conformities • Evaluate the need for action • Determine & implement actions • Recording of investigation & ATR • Reviewing preventive action taken & its effectiveness 48 12/22/2022
- 49. DEVICE MASTER FILE •Executive summary of the MD containing • The introductory description, intended use, indications, Class of MD, novel features of the device, shelf life, sterilization details etc. • Device description(variants &accessories) • Product specification, design, mfg process, • product verification & validation on biocompatibility, safety, animal studies, • stability, clinical evidence, vigilance reporting 49 12/22/2022
- 50. ENVIRONMENT REQUIREMENTS • SURGICALDRESSINGS- Class 9 of ISO • Weaving, assembly & gauzing, final pack • SUTURES- Class 9 & 8 • Extrusion (9),assembly& packing(8) • The area must be well lit, floors and walls well maintained without cracks and roofs must contain ceiling for protection. Area must be free from rodents,ants etc. 50 12/22/2022
- 51. STERILIZATION METHODS • Steamsterilization • Dry heat sterilization • Autoclaving • Radiation methods • ETO sterilization- preconditioning Chamber, Sterilization chamber,Aeration chamber • Biological indicators are used to check 12/22/2022 51
- 52. ISO 13485-2016 • TheGuidance contained in ISO 13485 is for improving the QMS specified for the manufacturing of Medical devices. • It contains requirements for improvement using feedback from sources like complaint handling, post market surveillances, handling of non conformities and CAPA. It is useful for regulatory compliances, product quality improvement 52 12/22/2022
- 53. EXPECTATION OF CUSTOMERS •RELIABLE • SAFE • EFFECTIVE • AFFORDABLE • PRECISE • SPEEDY RELIEF • DURABLE • EASY TO USE • PATIENT FRIENDLY USER MANUAL 12/22/2022 53
- 54. THANK YOU • MR Pradeep.M.Pharm • CEO,PHARMA FIRST • Muvattupuzha-686661. • Ph 9446056081 • Email: rdipradeep@gmail.com • Website: www.pharmafirstconsulting.com 12/22/2022 54