Medical Devices Act 2017 | Pharmacy Notes

Medical Devices Act, 2017, Pharmacy Notes, Jurisprudence, Pharmacy, D.Pharm, B.Pharm, Pharmapedia, ThePharmapedia

Medical Devices Act 2017

Regulatory body CDSCO (Central Drugs Standard Control Organisation) is responsible to regulate Medical Devices, In vitro devices(IVDs) & Drugs in India. CDSCO works under Ministry of Health & Family Welfare, Govt of India. DCGI is the head of CDSCO is responsible for regulating MD & Other regulation of D & C act 1940 & rule 1945. To Regulate Medical Devices in India, MoHFW notified Medical Devices Act (MDA) 2017. Prior to this, MD are regulated under D & C act 1940 & rule 1945. MD act 2017 has been effective from 1st January 2018. MD act deal with

  1. Medical devices (other than in vitro diagnosis devices)
  2. Medical Devices for In-Vitro Diagnosis

Definition of Medical Device

Medical devices are devices

  • intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease in man or other animals.
  •  intended to affect the structure or any function of the body of man or other animals.

To understand Medical devices act 2017,  MDA 2017 basically deal with two major sections i.e.

  1. Medical devices other than in vitro diagnostic
  2. Medical devices for in vitro diagnostic  (IVD)- Reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions. Example- Home Pregnancy Test, Glucose Test Strip.

Medical Devices Act applicable to substances used for

  • In-vitro diagnosis
  • Surgical Dressings
  • Surgical bandages
  • Surgical staples
  • Surgical sutures
  • Ligatures
  • Blood & Blood component collection bag with or without anticoagulant
  • Mechanical contraceptive (condoms, intrauterine devices, tubal rings)
  • Disinfectants & Insecticides
  • Any devices notified under D & C Avt 1940

Standards for Medical Devices

  • BIS (Bureau of Indian Standard) or
  • ISO (International Organisation for Standardisation) or
  • IEC (International Electro Technical Commission) 0r
  • Any Pharmacopoeial Standard or

As per MDA 2017, Medical Devices (MD) have been classified in four class (Class A, B, C & D) on the basis of their risk levels.

Classification of Medical Devices (MD)

In Schedule Ist of MD act 2017, MD are classified into four classes (Class A, Class B, Class C & Class D).

Part 1st  of Schedule 1st Deal with classification of medical devices other than in vitro diagnostic medical devices while part 2nd  deals with classification of  in vitro diagnostic medical devices. Schedule 1st  का Part 1st इन विट्रो डायग्नोस्टिक चिकित्सा उपकरणों के अलावा अन्य सभी चिकित्सा उपकरणों के classification  से संबंधित है, जबकि Part 2nd  इन विट्रो डायग्नोस्टिक चिकित्सा उपकरणों के classification से संबंधित है।

Medical Devices-Classification
Classification of Medical Devices based on risk levels.

Download complete list of devices with classification from CDSCO

Note: State Licencing has authority to issue licence

  1. for manufacturing of Class A & Class B Medical Devices.
  2. For sale, stock, exhibit or offer for sale or distribution of all Class of Medical Devices (Class A, B, C & D)
ChapterDescription
IPRELIMINARY
IIREGULATION OF MEDICAL DEVICE
IIIAUTHORITIES, OFFICERS AND BODIES
IVMANUFACTURE OF MEDICAL DEVICES FOR SALE OR FOR DISTRIBUTION
VIMPORT OF MEDICAL DEVICES
VILABELLING OF MEDICAL DEVICES
VIICLINICAL INVESTIGATION OF MEDICAL DEVICE AND CLINICAL PERFORMANCE EVALUATION OF NEW IN VITRO DIAGNOSTIC MEDICAL DEVICE
VIIIIMPORT OR MANUFACTURE MEDICAL DEVICE WHICH DOES NOT HAVE PREDICATE DEVICE
IXDUTIES OF MEDICAL DEVICE OFFICER,MEDICAL DEVICE TESTING OFFICER AND NOTIFIED BODY
XREGISTRATION OF LABORATORY FOR CARRYING OUT TEST OR EVALUATION
XISALE OF MEDICAL DEVICES
XIIMISCELLANEOUS
Chapter under Medical Devices Act 2017

Schedule to Medical Devices Act 2017

ScheduleDescription
FirstParameters for classification of medical devices and in vitro diagnostic medical devices Part -I:- classification of medical devices other than in vitro diagnostic medical devices (Class A, B, C & D) Part-II:- classification for in vitro diagnostic medical devices (Class A, B, C & D)
SecondFee (payable for licence, permission and registration certificate)
ThirdDocuments required for registration of Notified Body, its duties and functions Part-I:- Documents to be furnished along with application in Form MD-1 for grant of certificate of registration Part-II:- Duties and functions of Notified Body
FourtDocuments required for grant of licence to manufacturing of medical devices for sale or for distribution or import
FifthQuality Management System for medical devices and in vitro diagnostic medical devices
SixthPost approval change
SeventhRequirements for permission to import or manufacture investigational medical device for conducting clinical investigation
EighthExemptions
Schedule to Medical device act

Various Form of Medical Devices act 2017

FormDescription
MD 1Application for grant of Certificate of Registration of a Notified Body
MD 2Certificate of Registration for a Notified Body
MD 3Application for Grant of Licence to Manufacture of Class A or Class B medical device
MD 4Application for Grant of Loan Licence to Manufacture for Sale or for Distribution of Class A or Class B medical device
MD 5Licence to Manufacture for Sale or for Distribution of Class A or Class B Medical Device
MD 6Loan Licence to Manufacture for Sale or for Distribution of Class A or Class B medical device
MD 7Application for Grant of Licence to Manufacture for Sale or for Distribution of Class C or Class D
MD 8Application for Grant of Loan Licence to Manufacture for Sale or for Distribution of Class C or Class D
MD 9Licence to Manufacture for Sale or for Distribution of Class C or Class D
MD 10Loan Licence to Manufacture for Sale or for Distribution of Class C or Class D medical device
MD 11Form in which the Audit or Inspection Book shall be maintained
MD 12Application for licence to manufacture medical device for purpose of clinical investigations, test, evaluation, examination, demonstration or training
MD 13Licence to Manufacture Medical Devices for the Purposes of Clinical Investigations or Test or Evaluation or Demonstration or Training
MD 14Application for issue of import licence to import medical device
MD 15Licence to Import Medical Device
MD 16Application for Licence to Import Medical Devices for the Purposes of Clinical Investigations or Test or Evaluation or Demonstration or Training
MD 17Licence to Import Medical Devices for the Purposes of Clinical Investigations or Test or Evaluation or Demonstration or Training
MD 18Application for licence to import investigational medical devices for the purposes by a government hospital or statutory medical institution for the treatment of patients
MD 19Licence to import investigational medical device by a government hospital or statutory medical institution for the treatment of patients
MD 20Application for permission to import small quantity of medical devices for personal use
MD 21Permission to import of small quantity of medical devices for personal use
MD 22Application for Grant of permission to conduct clinical investigation of an investigational medical device
MD 23Permission to conduct Clinical Investigation
MD 24Application for grant of permission to conduct clinical performance evaluation of new in vitro diagnostic medical device
MD 25Permission to conduct clinical performance evaluation of new in vitro diagnostic medical device
MD 26Application for grant of permission to import / manufacture for sale or for distribution of medical device which does not have predicate medical device
MD 27Permission to import or manufacture for sale or for distribution of medical device which does not have predicate medical device
MD 28Application for grant of permission to Import or Manufacture for sale or for distribution of new in vitro diagnostic medical device
MD 29Permission to Import or Manufacture New In Vitro Diagnostic Medical Device
MD 30Memorandum to the Central Medical Device Testing Laboratory
MD 31Certificate of test or evaluation by the Central Medical Device Testing Laboratory
MD 32Report of Test or Evaluation of Medical Devices by Medical Device Testing Officer
MD 33Application from a purchaser for test or evaluation of a Medical Device under section 26 of the Drugs and Cosmetics Act, 1940 (23 of 1940)
MD 34Order under clause (c) of sub-section (1) of section of the Drugs and Cosmetics Act, 1940, (23 of 1940) requiring a person not to dispose of stock in his possession
MD 35Receipt for stock of medical devices for record, register, document or material object seized under clause (c) or clause (cc) of sub-section (1) of Section 22 of the Drugs and Cosmetics Act (23 of 1940)
MD 36Intimation of Person from Whom Sample is taken
MD 37Receipt for Sample of medical device(s) taken where fair price tendered thereof under sub-section (1) of Section 23 of the Drugs and Cosmetics Act, 1940 is refused
MD 38Memorandum to Medical Device Testing Officer
MD 39Application for grant of registration to Medical Device Testing Laboratory for carry out Test or Evaluation of a medical device on behalf of manufacturer
MD 40Certificate of registration to Medical Device Testing Laboratory for carry out Test or Evaluation of a medical device on behalf of manufacturer
Form MD Act 2017

Important Form number for Application to obtain License and to get License granted:

DescriptionApplication in formGrant in Licence
Registration of a Notified BodyMD 1MD 2
To licence Manufacture of Class A or Class B medical device
Loan licence Manufacture of Class A or Class B medical device respectively
MD 3
MD4
MD 5
MD 6
Licence to Manufacture for Sale or for Distribution of Class C or Class D   Loan Licence to Manufacture for Sale or for Distribution of Class C or Class DMD 7     MD 8MD 9     MD 10
licence to manufacture medical device for purpose of clinical investigations, test, evaluation, examination, demonstration or trainingMD 12MD 13
import licence to import medical deviceMD 14MD 15
Import Medical Devices for the Purposes of Clinical Investigations or TestMD 16MD 17
import investigational medical devices for the purposes by a government hospital or statutory medical institution for the treatment of patientsMD 18MD 19
permission to import small quantity of medical devices for personal useMD 20MD 21
permission to conduct clinical investigation of an investigational medical deviceMD 22MD 23
conduct clinical performance evaluation of new in vitro diagnostic medical deviceMD 24MD 25
permission to import / manufacture for sale or for distribution of medical device which does not have predicate medical deviceMD 26MD 27
Import or Manufacture of new in vitro diagnostic medical deviceMD 28MD 29
registration to Medical Device Testing LaboratoryMD 39MD 40
Important form number

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