Information

Medical devices

GUIDELINES FOR IMPORT AND MANUFACTURE OF MEDICAL DEVICES

The Ministry of Health and F.W. under Gazette notification S.O. 1468 (E) dated 6/10/2005 declared the following sterile devices to be considered as drugs under Section 3 (b) (iv) of the Act.

  • Cardiac Stents.
  • Drug Eluting Stents.
  • Catheters.
  • Intra Ocular Lenses.
  • I.V. Cannulae.
  • Bone Cements.
  • Heart Valves.
  • Scalp Vein Set.
  • Orthopedic Implants.
  • Internal Prosthetic replacements.
 

It was also notified vide GSR 627 (E) dated 7/10/2005 that control over manufacture of these devices would be exercised by CLAA i.e. DCG(I) under the said Rules.

The Ministry of Health and Family Welfare have now approved the following procedures to be adopted in respect of licensing of import as well as manufacture of these Medical Devices in the country.

NEW MEDICAL DEVICE RULES 2017 (New-Guidelines)

Government of India has introduced new medical devices rules that are being implemented from 1/1/2018.

The salient points of the new rules are as follows:

  • A new portal, SUGAM, has been created for the online application of import or manufacturing applications.
  • Form 10 license that were required as per the old rules has been abolished. Each and every importer has to get import registration certificate/ licensefrom CDSCO.
  • New forms for application and license have been prescribed Manufacturing/ Import license for various medical devices.

    Briefly, fees for manufacturing/ import have been enhanced by the government. Fee structure for manufacturing, import registration for each device and manufacturing site, testing is annexed.

    Devices have been classified as A, B, C, D based on risk factor
    Classification details available on CDSCO website
  • In summary, Documents required for both manufacturing and import are listed below:

    Plant Master File
    Device Master File
    CE certificate duly notarized
    ISO13485 for duly notarized
    Free Sale Certificate Duly Notarized

    Other regulatory certificates (New medical device Rules-CDSCO)
  • Recently, Government has issued that the following medical devices
    will be regulated12 months from date of notice Link
     

 

REGISTRATION OF MEDICAL DEVICES FOR IMPORT (Old- Guidelines)

  • Application for Registration Certificate in respect of the premises and the devices manufactured by the manufacturer and meant for import into India is required to be made by the manufacturer or importer or his agent in India, in Form 40 and in form and manner as under Rule 24A of the Drugs and Cosmetics Rules. The application addressed to the Drugs Controller General (India) shall be deposited at the CDSCO, FDA Bhawan, Kotla Road, Near Mata Sundari College, ITO, New Delhi-110002.
  • A fee of US$ 1500 or its equivalent shall be paid alongwith the application as registration fee for the premises where the devices, intended to be imported are being manufactured by the manufacturer.
  • A fee of US$ 1000 or its equivalent shall be paid for registration of single Medical Device (which may include variation in sizes or shape without any change in the material or method of use) and an additional fee US$1000 for each additional device shall be paid.
  • The fee shall be paid through a challan in the Bank of Baroda as prescribed under the said Rules.
  • The informations and undertakings required to be furnished under Schedule DI and DII may be modified to suit the requirements of devices in place of normal pharmacological products. The information shall include the following details:-
 

(A) Applicant Details

  • Applicant’s company name, address and contact number.
  • Name and address of foreign manufacturer (Manufacturing premises).
  • Copy of the Plant Master File.
  • Name and address of the local authorized representative.
  • Name and address of the importer.
  • Local manufacturer, if any processing is being done in the country.
 

(B) Product Information

  • Proprietary/Brand name.
  • Brief description of the device.
  • Category of device.
  • Intended use and method of use.
  • Medicals specialty in which the device is used.
  • Qualitative and quantitative particulars of the constituents.
  • Brief description of the method of the manufacture and specification of the materials used.
  • Contraindications, warnings, precautions potential adverse events and alternate therapy, wherever applicable.
  • List of accessories and other devices or equipment to be used in combination with the device. Other descriptive information, including accessories packaged with the product.
  • Variations in shape, style or size of the device, if applicable.
  • Labeling details conforming to Drugs and Cosmetics Rules, 1945.
  • Physician manual and promotional literature (Literature insert) in English.
  • Packaging description including pack sizes.
  • Recommended storage conditions.
  • Summary indications of any reported problems.
  • Details of standards to which the device conform alongwith the copy of the standard.
 

(C) Regulatory Status

  • Approval of the product from any other regulatory agency (Separate evidence for the approval from the each agency)
    • US FDA clearance/approval.
    • EU medical device directive (CE Certificate).
    • Australia/Canada/Japan approval.
    • Approval in any other country.
  • Copy of ISO/EN Certification if any for the manufacturing facility.
  • List of countries where the device is being sold.
  • List of countries where device is withdrawn from sale with reasons, if any
 

(D) Master File (Details of Good Manufacturing Practices employed by the manufacturer to ensure quality of the device)

  • Component/Material used.
  • Device Master File.
  • Manufacturing process/Flow Chart.
  • Quality Assurance procedures/process controls.
  • Final product testing or design inputs/outputs verification, if applicable.
  • Functionality Test protocol and report, if applicable.
  • Risk Assessment as per ISO 14971.
  • Sterilization process and validation/verification.
  • Stability data or statement of established stability of material used as applicable.
  • Shelf life of the device.
  • Biocompatibility and Toxicological data, wherever applicable.
  • Device GMP Certificate.
 

(E) Devices containing medicinal product

  • If device incorporates a medicinal product, which is liable to act upon the body with action ancillary to that of the device, data on the safety, quality and usefulness of the medicinal substance used.
  • Data on compatibility with medicinal products, if device intended to deliver medicinal products.
  • Clinical data and published articles, if any.
  • Batch Release Certificate for products incorporating any medicinal substance or substances of animal origin.
  • For devices not approve for marketing in the country of origin, the applicant shall submit reports of clinical trials, details of sales, certificates of satisfactory use from the medical specialists about the use of the device and details of product complaints, if any.

    (Medical Devices with prior approval from any of the recognized regulatory authorities will be subjected to an abridged evaluation and only a summary of all the studies and information described above is to be submitted)
 

(F) Post Market Surveillance

  • Procedures for distribution of records.
  • Complaint handling.
  • Adverse incident reporting.
  • Procedure for product recall.
 

(G) Undertaking of conformity with respect to product standards, safety and effectiveness requirements and quality systems in the country of origin.

  • The Registration Certificate shall be issued in Form 41 of the said Rules.
  • The application for import licence shall be made in Form 8 alongwith a fee of Rs. 1000/- in the Form and manner prescribed under the Drugs and Cosmetics Rules.
 

MANUFACTURE OF MEDICAL DEVICES IN THE COUNTRY

  • Application for the grant of licence for manufacture of these notified sterile Devices in the country shall be made in Form 27 to the State Licensing Authority, accompanied by the requisite fee in the Form and manner as prescribed in the said Rules alongwith a copy to the office of DCG(I).
  • A period of 60 days would be provided for making the application for manufacture from the date of publication of these guidelines.
  • In case of devices belonging to above said categories which have not been manufactured in the country before the date of notification, no manufacture would be permitted hence forth without the approval of the competent authority as per norms prescribed.
  • The applicant shall provide the following information alongwith the application for consideration of the licensing authority.
    Manufacturing Details:-
    • Complete details about the names, addresses of the directors of the company and addresses of the manufacturing premises and registered offices of the manufacturer.
    • A brief project highlight indicating the plans of the company, devices to be manufacture, their viability and other relevant profiles.
    • Copy of the Site Master File.
    • A brief description of the manufacturing process of the devices to be manufactured.
    • Details of the standards followed by the company for Good Manufacturing Practices and product evaluation.
    • Name, qualification and experience of technical staff under whose supervision the devices will be manufactured.
    • Copies of ISO or any other certifications, if any, obtained by the firm for its manufacturing facility.
    Product Details:-
    • Proprietary/Brand name.
    • Brief description of the device.
    • Category of device.
    • Intended use and method of use.
    • Medical specialty in which the device is used.
    • Qualitative and quantitative particulars of the constituents.
    • Specifications of the materials used.
    • Testing facilities available in the manufacturing premises for testing.
    • Standards and procedures for testing the device.
    • Contraindications, warnings, precautions potential adverse events and alternate therapy, wherever applicable.
    • List of accessories and other devices or equipment to be used in combination with the device. Other descriptive information, including accessories packaged with the product.
    • Information on stability of the product.
    • Details of clinical trials, (wherever applicable) carried out on the product.
    • Variations in shape, style or size of the device, if applicable.
    • Labeling details conforming to Drugs and Cosmetics Rules, 1945.
    • Physician manual and promotional literature (Literature insert) in English.(if any)
    • Packaging description including pack sizes.
    • Recommended storage conditions.
    • Summary indications of any reported problems.
  • For the purpose of evaluation of Medical Devices which are new or do not have any benchmark certification, Expert Committees shall be setup to examine in detail the information provided by the applicant for the assessment of the device.
  • The committee after completing their assessment forward the opinion regarding suitability of the device to the competent authority for the purpose of grant of permission for placing the device in the market.
  • The State Licensing Authority after Joint Inspection and verification would forward the licence to CLAA for approval.
  • The licence shall be issued in Form 28 of the said Rules after due approval of CLAA.
 

Wholesale Drugs Sale license

List of documents required for applying for the whole sale drug licence
  • Form 19 duly filled with court fee stamp for Rs.2/- for each Licence.
  • Declaration Form
  • Licence Fees of Rs. 1500/- for each Licence paid by challan in State Bank of India for form 20 / 21 / 20 B / 21 B. For Licence in Form 20 F / 20 G, Licence Fee is Rs.500/- for each Licence.
  • Partnership deed in Rs.300/- Stamp paper – Memorandum of Association / Articles of Association for Private Limited / Limited concerns. For change in Constitution / Retirement Deed / Reconstitution Deed in Rs. 100/- Stamp paper.
  • Rental Agreement in Rs.50/- Stamp Paper for minimum period of 5 years with relevant property Licence or copy of relevant property document.
  • Legal Tenancy Affidavit Rs. 20/- Stamp paper.
  • Blue Print of the plan of the premises duly signed by Licenced Engineer, and the applicant. Minimum area of a detail (Licence in Form 20 / 21) shall be 10 square meter (preferable to have 15 square meter).
  • Copy of Registration Certificate of registered Pharmacist.
  • Affidavit of Registered pharmacist in Rs.20/- stamp paper.
  • Copy of Qualification and Experience Certificate of Competent person for grant of licence in From 20B / 21B. Competent person shall be a Registered Pharmacist or a person with degree certificate with 1 year experience in Drug Trade of S.S.L.C. with 4 years experience in Drug Trade. The experience Certificate for Competent person should accompanied by the Pay acquittance for the experience period and copy of the attendance register.
  • Two recent passport size photos of Proprietor / Partner / Managing Director
  • Proof of residence – copy of Ration card / Driving Licence / Voter’s Card.
  • Purchase bill of refrigerator, Air-Conditioner and Generator.
  • If the applicant is for grant of Licence due to change in constitution / Change of premises, working condition Certificate for the Refrigerator from a competent firm.
  • Separate declaration as per rule 62 B 2(II) of Drugs & Cosmetics Rules indicating the occupation, trade or Business carried on by such applicant for the preceding three years.
  • Self addressed stamped (Rs.50/-) envelope ( 35 c.m. x 25 c.m.).
  • Premises should be air-conditoned with generator.
  • All documents shall be duly attested by gazetted officer or Notary Public.

    The completed application shall be duly signed by the applicant with date and enter all the particulars in the application form and declaration form without any omission and ambiguity.

    The application file shall be properly tied and shall have a check list of the documents enclosed.
 

Retail Drugs Sale license

The following are the requirement for getting Drug licence for stocking & selling Drugs by Retail
  • Covering letter to concerned State Drugs controller affixing the required court fees stamp.
  • Application in Form no 19(Two numbers) to be filled for SCH C&CI &Non C&CI Drugs along with fees Rs 1500 for each form & thus a total of Rs 3000 as official fees to be paid to state Drugs controller.tru Challan
  • Form No 19C to be filled for selling Sch X Drugs with fees of Rs 500/-
  • An area of 120 Sq ft & 65 Sq ft(For Dispensing of Drugs as per Sch N) are minimum for for starting a retail Shop. So a total of 185 Sq ft is minimum for Dispensing & Chemists & Druggist Store. The flooring & walls shall be smooth surface for capable of easy cleaning.
  • The above total area shall be Airconditioned
  • Adequate capacity of Refrigerators are to be installed for storing Drugs between 2 to 15degree centigrade
  • Generator required in the event of failure of power.
  • Registered Pharmacist is must –
  • Adequate racks & cupboard shall be provided for stocking the Drugs.
  • Schedule N shall be complied for Dispensing of Drugs(List enclosed)
  • Proof of the Building engaged in Retail Licence ie Property Tax receipt
  • Rental or lease agreement for minimum of 5 years for the place of retail store between the owner & tenant
  • Plan of the premises
  • Company memorandum of article or partnership deed along with list of Directors & their address & their Photos
  • Self addressed envelope with stamp for Registered post.
  • A declaration Form duly filled & signed by the Pharmacist as fulltime employee
  • A declaration form duly filled & signed by the Applicant
 

Drugs

The following are the documents required for applying for the registration of manufacturer’s SITE and Drug.

  • Covering letter
  • An Authorisation letter
  • Form – 40
  • TR – 6 Challan -- Fees
  • Power of Attorney
  • Legal undertaking by way of an affidavit
  • Whole Sale Drug Licence
  • Schedule D – (I)
  • Plant Master File (Site Master File)
  • Schedule D – (II)
  • Drug Master File
  • Free Sale Certificate / Cert. to foreign Govt. / Certificate of marketability
  • COPP
  • Manufacturing licence and/or Market authorization certificate in respect of the applied drugs
  • Valid copy of the Establishment License in respect of the foreign manufacturing sites.
  • Copy of the Inspection / audit report latest carried out by the National Regulatory Authority of the country of origin or other regulatory authorities like USFDA, MHRA, EU and TGA.

 

COSMETICS

Guidelines on Registration of Import of cosmetics given by CDSCO