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
- Medical devices (other than in vitro diagnosis devices)
- 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.
- Medical devices other than in vitro diagnostic
- 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।
Download complete list of devices with classification from CDSCO
Note: State Licencing has authority to issue licence
- for manufacturing of Class A & Class B Medical Devices.
- For sale, stock, exhibit or offer for sale or distribution of all Class of Medical Devices (Class A, B, C & D)
| Chapter | Description |
| I | PRELIMINARY |
| II | REGULATION OF MEDICAL DEVICE |
| III | AUTHORITIES, OFFICERS AND BODIES |
| IV | MANUFACTURE OF MEDICAL DEVICES FOR SALE OR FOR DISTRIBUTION |
| V | IMPORT OF MEDICAL DEVICES |
| VI | LABELLING OF MEDICAL DEVICES |
| VII | CLINICAL INVESTIGATION OF MEDICAL DEVICE AND CLINICAL PERFORMANCE EVALUATION OF NEW IN VITRO DIAGNOSTIC MEDICAL DEVICE |
| VIII | IMPORT OR MANUFACTURE MEDICAL DEVICE WHICH DOES NOT HAVE PREDICATE DEVICE |
| IX | DUTIES OF MEDICAL DEVICE OFFICER,MEDICAL DEVICE TESTING OFFICER AND NOTIFIED BODY |
| X | REGISTRATION OF LABORATORY FOR CARRYING OUT TEST OR EVALUATION |
| XI | SALE OF MEDICAL DEVICES |
| XII | MISCELLANEOUS |
Schedule to Medical Devices Act 2017
| Schedule | Description |
| First | Parameters 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) |
| Second | Fee (payable for licence, permission and registration certificate) |
| Third | Documents 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 |
| Fourt | Documents required for grant of licence to manufacturing of medical devices for sale or for distribution or import |
| Fifth | Quality Management System for medical devices and in vitro diagnostic medical devices |
| Sixth | Post approval change |
| Seventh | Requirements for permission to import or manufacture investigational medical device for conducting clinical investigation |
| Eighth | Exemptions |
Various Form of Medical Devices act 2017
| Form | Description |
| MD 1 | Application for grant of Certificate of Registration of a Notified Body |
| MD 2 | Certificate of Registration for a Notified Body |
| MD 3 | Application for Grant of Licence to Manufacture of Class A or Class B medical device |
| MD 4 | Application for Grant of Loan Licence to Manufacture for Sale or for Distribution of Class A or Class B medical device |
| MD 5 | Licence to Manufacture for Sale or for Distribution of Class A or Class B Medical Device |
| MD 6 | Loan Licence to Manufacture for Sale or for Distribution of Class A or Class B medical device |
| MD 7 | Application for Grant of Licence to Manufacture for Sale or for Distribution of Class C or Class D |
| MD 8 | Application for Grant of Loan Licence to Manufacture for Sale or for Distribution of Class C or Class D |
| MD 9 | Licence to Manufacture for Sale or for Distribution of Class C or Class D |
| MD 10 | Loan Licence to Manufacture for Sale or for Distribution of Class C or Class D medical device |
| MD 11 | Form in which the Audit or Inspection Book shall be maintained |
| MD 12 | Application for licence to manufacture medical device for purpose of clinical investigations, test, evaluation, examination, demonstration or training |
| MD 13 | Licence to Manufacture Medical Devices for the Purposes of Clinical Investigations or Test or Evaluation or Demonstration or Training |
| MD 14 | Application for issue of import licence to import medical device |
| MD 15 | Licence to Import Medical Device |
| MD 16 | Application for Licence to Import Medical Devices for the Purposes of Clinical Investigations or Test or Evaluation or Demonstration or Training |
| MD 17 | Licence to Import Medical Devices for the Purposes of Clinical Investigations or Test or Evaluation or Demonstration or Training |
| MD 18 | Application for licence to import investigational medical devices for the purposes by a government hospital or statutory medical institution for the treatment of patients |
| MD 19 | Licence to import investigational medical device by a government hospital or statutory medical institution for the treatment of patients |
| MD 20 | Application for permission to import small quantity of medical devices for personal use |
| MD 21 | Permission to import of small quantity of medical devices for personal use |
| MD 22 | Application for Grant of permission to conduct clinical investigation of an investigational medical device |
| MD 23 | Permission to conduct Clinical Investigation |
| MD 24 | Application for grant of permission to conduct clinical performance evaluation of new in vitro diagnostic medical device |
| MD 25 | Permission to conduct clinical performance evaluation of new in vitro diagnostic medical device |
| MD 26 | Application for grant of permission to import / manufacture for sale or for distribution of medical device which does not have predicate medical device |
| MD 27 | Permission to import or manufacture for sale or for distribution of medical device which does not have predicate medical device |
| MD 28 | Application for grant of permission to Import or Manufacture for sale or for distribution of new in vitro diagnostic medical device |
| MD 29 | Permission to Import or Manufacture New In Vitro Diagnostic Medical Device |
| MD 30 | Memorandum to the Central Medical Device Testing Laboratory |
| MD 31 | Certificate of test or evaluation by the Central Medical Device Testing Laboratory |
| MD 32 | Report of Test or Evaluation of Medical Devices by Medical Device Testing Officer |
| MD 33 | Application 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 34 | Order 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 35 | Receipt 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 36 | Intimation of Person from Whom Sample is taken |
| MD 37 | Receipt 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 38 | Memorandum to Medical Device Testing Officer |
| MD 39 | Application for grant of registration to Medical Device Testing Laboratory for carry out Test or Evaluation of a medical device on behalf of manufacturer |
| MD 40 | Certificate of registration to Medical Device Testing Laboratory for carry out Test or Evaluation of a medical device on behalf of manufacturer |
Important Form number for Application to obtain License and to get License granted:
| Description | Application in form | Grant in Licence |
| Registration of a Notified Body | MD 1 | MD 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 D | MD 7 MD 8 | MD 9 MD 10 |
| licence to manufacture medical device for purpose of clinical investigations, test, evaluation, examination, demonstration or training | MD 12 | MD 13 |
| import licence to import medical device | MD 14 | MD 15 |
| Import Medical Devices for the Purposes of Clinical Investigations or Test | MD 16 | MD 17 |
| import investigational medical devices for the purposes by a government hospital or statutory medical institution for the treatment of patients | MD 18 | MD 19 |
| permission to import small quantity of medical devices for personal use | MD 20 | MD 21 |
| permission to conduct clinical investigation of an investigational medical device | MD 22 | MD 23 |
| conduct clinical performance evaluation of new in vitro diagnostic medical device | MD 24 | MD 25 |
| permission to import / manufacture for sale or for distribution of medical device which does not have predicate medical device | MD 26 | MD 27 |
| Import or Manufacture of new in vitro diagnostic medical device | MD 28 | MD 29 |
| registration to Medical Device Testing Laboratory | MD 39 | MD 40 |
Join WhatsApp channel to get latest Job notification, Study material, Previous paper, MCQ quiz, Admission alerts & News etc. for Pharmacy aspirants.
Subscribe our Telegram channel for Pharmacy Notes, MCQ Quiz, , Previous paper, Admission alerts & News etc. for Pharmacy professionals.
Join Telegram group for all Pharmacy books, Pharmacopoeia (IP, USP, BP), Pharmacy Notes, Previous Year Question papers in pdf format.
Find us on social platform-
