Section 2017 in The Medical Devices Rules, 2017

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Union of India - Section

Section 2017 in The Medical Devices Rules, 2017

2017.

Place: __________	Signature
Date: ___________	(Name and designation)
	[To be signed digitally]

Annexure

S.N.	Generic name	Model No.	Intended use	Class of medical device	Material of construction	Dimension (if any)	Shelf life	Sterile or Non sterile	Brand Name (if registered under the Trade MarksAct, 1999)

Form MD-15[See sub-rule (1) of rule 36]Licence to Import Medical DeviceLicence No.: _______________

1.	M/s ___________________________ (Name, full address, as perwholesale licence/ manufacturing licence, of authorized agentwith telephone and e-mail address) is hereby licenced to importthe medical device(s) manufactured by overseas manufacturerhaving manufacturing site as specified below.
2.	Details of overseas manufacturer and manufacturing site underthis licence.
	{\|
Sr. No.	Name & address of overseas manufacturer(full address with telephone and email address of themanufacturer)	Name & address of overseas manufacturingsite (full address with telephone and e-mail address of themanufacturing site)

|-| 3.| Details of medical device(s) [Annexed].|-| 4.| The authorized agent M/s. ________________________ will beresponsible for the business activities of the overseasmanufacturer, in India in all respects.|-| 5.| This licence is subject to the provisions of the MedicalDevices Rules, 2017 and conditions prescribed therein.|}

Place: __________	Central Licensing Authority
Date: ___________	Seal or Stamp

Annexure

S.N.	Generic name	Model No.	Intended use	Class of medical device	Material of construction	Dimension (if any)	Shelf life	Sterile or Non sterile	Brand Name (if registered under the Trade MarksAct, 1999)

Form MD-16[See sub-rule (2) of rule 40]Application for Licence to Import Medical Devices for the Purposes of Clinical Investigations or Test or Evaluation or Demonstration or Training

1.	Name of applicant:
2.	Address of applicant including telephone number, mobilenumber, fax number and e-mail id:
3.	Name and Address of device Manufacturer:
4.	Name and Address of site(s) where test or evaluation isproposed to be conducted:
5.	Details of medical device(s) to be imported [Annexed].
6.	Brief description of the medical device
7.	Purpose of import
8.	Justification for quantity to be imported
9.	An undertaking stating that required facilitiesincluding equipment, instrument and personnel have been providedto test or evaluate medical device
10.	An undertaking stating that the medical deviceproposed to be imported to be used exclusively for purposespecified at serial number 7 and shall not be used for commercialpurpose
11.	Fee paid on _______________ Rs____________________ receipt/challan/ transaction id___________.
12.	I hereby state and undertake that, I shall comply with allapplicable provisions of the Drugs and Cosmetics Act, 1940 (23 of1940) and the Medical Devices Rules, 2017.

Place: __________	Signature
Date: ___________	(Name and designation)
	[To be signed digitally]

Annexure

S.N.	Generic name	Model No.	Intended use	Class of medical device	Material of construction	Dimension (if any)	Shelf life	Sterile or Non sterile	Brand Name (if registered under the Trade MarksAct, 1999)

Form MD-17[See sub-rule (1) of rule 41]Licence to Import Medical Devices for the Purposes of Clinical Investigations or Test or Evaluation or Demonstration or Training

1.	M/s.............................................is hereby licenced to import the medical device specified belowfrom M/s ..................... (Name and full address of overseasmanufacturer) for the purposes of clinical investigations or testor evaluation or demonstration or training at........................ (Name and address, where clinicalinvestigations or test or evaluation or is to be carried out).
2.	This licence is subject to conditions prescribed under theMedical Devices Rules, 2017.
	{\|
S.N.	Generic name	Class of medical device	Quantity permitted to be imported

|-| 3.| This licence shall, unless previously suspended or revoked, bein force for a period of three year from the date specifiedbelow:-|}

Place: __________	Central Licensing Authority
Date: ___________	[To be signed digitally]

Form MD-18[See sub-rule (1) of rule 42]Application for licence to import investigational medical devices for the purposes by a government hospital or statutory medical institution for the treatment of patients

1.	I ................................. (Name anddesignation) ................................................ of....................................... (Name of the GovernmentHospital or Statutory Medical Institution) hereby apply for alicence to import small quantities of investigational medicaldevice specified below manufactured by M/s................................ (Name and full address ofoverseas manufacturer) for the purpose of treatment of patientsfor the disease .................................................(Name of the disease)................................................... at..................................... (name and address of thehospital).
2.	Details of medical device to be imported:
	{\|
Name of the investigational Medical device	Name and address of the manufacturer	Quantities which may be imported

|-| 3.| I shall comply with the provisions of the Drugs and CosmeticsAct, 1940 (23 of 1940) and the Medical Devices Rules, 2017.|-| 4.| A fee of Rs. _____________________ has been credited to theGovernment under the Head through Challan/ receipt No. _____________dated _________________ (copy attached).|}

Place: __________	Signature .........................
Date: ___________	Name ...............................
	Seal or Stamp .................

CertificateCertified that the investigational medical device specified above for import are urgently required for the treatment of patients suffering from .................... and that the said medical device is not available in India.

Place: __________	Signature ..........................................
Date: ___________	Medical Superintendent of the Government Hospital/Head of Statutory Medical Institution Seal or Stamp

Form MD-19[See sub-rule (2) of rule 42]Licence to import investigational medical device by a government hospital or statutory medical institution for the treatment of patientsLicence No. ________________________________

1.	Dr. ___________________________ (Name anddesignation) of _________________ (Name of Hospital or StatutoryMedical Institution) here by grant licence to import from M/s....................... (Name and full address of manufacturer)the medical devices specified below for the purpose of treatmentof patients for the disease ___________ (name of the disease) at..................................... (name and address of thehospital).
2.	Details of medical device to be imported:
	{\|
Name of medical device	Quantities which may be imported

|-| 3.| This licence shall, unless previously suspended or revoked, bein force for a period of one year from the date of issuespecified above.|}

Place: __________	Central Licensing Authority
Date: ___________	Seal or Stamp

Form MD-20[See sub-rule (2) of rule 43]Application for permission to import small quantity of medical devices for personal useToThe Central Licensing Authority,__________________________________________________Sir/ Madam,

1.	I ..........................................resident of....................... by occupation................... hereby apply for a permission to import themedical device specified below for personal use manufactured by.............................. (Name and full address ofmanufacturer) for the treatment of .................. (name ofthe disease).
	{\|
Name of medical device	Quantity which may be imported

|-| 2.| The prescription from a registered medical practitionerprescribing the need for the said medical device is attached.|-| 3.| The particular of the patients is specified below.|-||

Name	Age	Gender	Complete Address

Place: __________	Signature of applicant
Date: ___________

Form MD-21[See sub-rule (3) of rule 43]Permission to import of small quantity of medical devices for personal use

Permit No. _____________________

Date __________________

1.	....................................is herebypermitted to import the medical device manufactured by.............................. (Name and full address ofmanufacturer) specified below for personal use.
	{\|
Name of the medical device	Quantity

|-| 2.| This licence is subject to conditions prescribed in theMedical Devices Rules, 2017.|-| 3.| This licence shall, unless previously suspended or revoked, bein force for a period of one hundred and eighty days from thedate of issue specified above.|}Central Licensing AuthoritySeal or StampForm MD-22[See sub-rule (1) of rule 51]Application for Grant of permission to conduct clinical investigation of an investigational medical device

1.	Name of Applicant:
2.	Nature and constitution of applicant:
	(i.e. proprietorship, partnership including Limited LiabilityPartnership, company, society, trust, other to be specified)
3.	(i)	Sponsor address including telephone number, mobile number, faxnumber and e-mail id:
	(ii)	Clinical investigation site address including telephonenumber, mobile number, fax number and e-mail id:
	(iii)	Address for correspondence:
4.	Details of investigational medical device(s) and Clinicalinvestigation site [Annexed].
5.	Clinical investigation plan number with date:
6.	Fee paid on _______________ Rs. ____________________ receipt/challan/ transaction id ___________.
7.	I have enclosed the documents as specified in the SeventhSchedule of Medical Devices Rules, 2017.
8.	I hereby state and undertake that:
	(i)	I shall comply with all the provisions of the Drugs andCosmetics Act, 1940 and the Medical Devices Rules, 2017.

Place: __________	Signature
Date: ___________	(Name and designation)
	[To be signed digitally]

Annexure

S. N.	Generic name	Intended use	Class of medical device

S. N.	Name and address of site(s)	Ethics Committee details	Name of Principle Investigator

Form MD-23[See clause (i) of rule 52]Permission to conduct Clinical InvestigationPermission No. __________

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Union of India - Section

Section 2017 in The Medical Devices Rules, 2017

2017.