device registration in india

WELCOMEWELCOMEAccredited Accredited

Consultants PvtConsultants Pvt.. Ltd Ltd..

What is a Medical Device ?What is a Medical Device ?

Devices intended for internal or external

use in the diagnosis, treatment, mitigation

or prevention of diseases or disorders in

human beings or animals.

Accredited Consultants Pvt. Ltd.

Who is the Regulatory Body ?Who is the Regulatory Body ?

The Drugs Controller General (India) of Central

Drugs Standard Control Organisation (CDSCO) is the

Regulatory Authority That:

Governs the Import,

manufacture,

sale and distribution of Medical Devices under the

Drug & Cosmetic Act 1940 & Rules.Accredited Consultants Pvt. Ltd.

Hierarchy of Medical Device Hierarchy of Medical Device Regulatory entities in IndiaRegulatory entities in India


Ministry of Health and Family Welfare

Drug Controller General of India - DCG(I)

Drug Controller General of India - DCG(I) Central Drugs Standard Control Organisation (CDSCO - Medical Devices Division)

Medical Devices Regulated In IndiaMedical Devices Regulated In India

Only Medical Devices that are

Notified under Drugs and Cosmetics

Acts are Regulated in India.


Notified Medical Devices Notified Medical Devices Disposable Hypodermic Syringes Disposable Hypodermic Needles Disposable Perfusion sets In-Vitro Diagnostic Devices for HIV, HbsAg and HCV Cardiac Stents Drug Eluting Stents Catheters Intra Ocular Lenses I.V. Cannulae Bone Cements Heart Valves Scalp Vein Set Orthopaedic Implants Internal Prosthetic Replacements


DEVICE

REGISTRATION

DRUG REGULATION SYSTEM IN INDIADRUG REGULATION SYSTEM IN INDIA

Drug Controller General of India is the head of

Central Drug Standard Control Organisation , which

regulates Devices & Drugs in India.

TR Challan: Fees of 1500 USD is required for site

registration and 1000 USD for registration of each

product.



FLOW CHART FOR REGISTRATIONFLOW CHART FOR REGISTRATION

Legal Documents Regulatory documents Technical Documents

Form 40 POA, DI & DII Undertakings Labels/Inserts

LEGAL DOCUMENTSLEGAL DOCUMENTSDocuments To be submitted by Indian agentForm 40- It should be signed and stamped by Indian agent.

Documents To be submitted by ManufacturerPOA- Power of attorney should be Appostilised or

Consularized from Indian embassy of country of origin, and should be co-jointly signed by both the parties i.e. Manufacturer and Indian Agent.

Schedule DI & DII- They should be signed and stamped by Manufacturer. (Need not to be notarized)


REGULATORY DOCUMENTSREGULATORY DOCUMENTSNotarized Plant Registration Certificate Notarized Manufacturing & Marketing LicenseNotarized Free Sale Certificate Notarized EU medical device directive (CE Certificate). CE Declaration of Conformity NotarizedNotarized CE Design CertificateNotarized CE full quality AssuranceGMP Certificate NotarizedISO Certificate NotarizedWhole Sale License (20B & 21B) of Indian Agent


Technical DocumentsTechnical Documents

I. Plant Master FileI. Plant Master File1.GENERAL INFORMATION Brief information on the site (including name and

address), relation to other sites Manufacturing activities as licensed by the Competent

AuthoritiesAny other operations carried out on the site Name and exact address of the site, including

telephone, fax numbers, web site URL and e-mail address


Type of medical devices handled on the site and information about specifically toxic or hazardous substances handled, mentioning the way they are handled and precautions taken

Short description of the site (size, location and immediate environment and other activities on the site

Number of employees engaged in Production, Quality Control, warehousing, and distribution

Use of outside scientific, analytical or other technical assistance in relation to the design, manufacture and testing

Short description of the quality management system of the company

Devices details registered with foreign countries


2.PERSONNEL Organization chart showing the arrangements for

key personnel Qualifications, experience and responsibilities of

key personnel Outline of arrangements for basic and in-service

training and how records are maintained Health requirements for personnel engaged in

production Personnel hygiene requirements, including clothing


3. PREMISES AND FACILITIES Layout of premises with indication of scale Nature of construction, finishes/fixtures and fittings Brief description of ventilation systems. More details

should be given for critical areas with potential risks of airborne contamination (including schematic drawings of the systems). Classification of the rooms used for the manufacture of sterile products should be mentioned

Special areas for the handling of highly toxic, hazardous and sensitizing materials

Brief description of water systems (schematic drawings of the systems are desirable) including sanitation

Maintenance (description of planned preventive maintenance programs for premises and recording system)


4. EQUIPMENT Brief description of major production and quality

control laboratories equipment (a list of the equipment is required)

Maintenance (description of planned preventive maintenance programs and recording system

Qualification and calibration, including the recording system. Arrangements for computerized systems validation.

5. SANITATION Availability of written specifications and procedures for

cleaning the manufacturing areas and equipments


6. PRODUCTION Brief description of production operations using,

wherever possible, flow sheets and charts specifying important parameters

Arrangements for the handling of starting materials, packaging materials, bulk and finished products, including sampling, quarantine, release and storage.

Arrangements for reprocessing or rework Arrangements for the handling of rejected materials

and products Brief description of general policy for process

validation


7. QUALITY CONTROLS Description of the Quality Control system and of

the activities of the Quality Control Department. Procedures for the release of finished products

8. STORAGE Policy on the storage of medical device

9. DOCUMENTATION Arrangements for the preparation, revision and

distribution of necessary documentation, including storage of master documents


10. MEDICAL DEVICE COMPLAINTS AND FIELD

SAFETY CORRECTIVE ACTION Arrangements for the handling of complaints Arrangements for the handling of field safety

corrective action 11. SELF INSPECTION Short Description of the internal audit system 12. CONTRACT ACTIVITIES Description of the way in which the compliance of

the contract acceptor is assessed


II. Device Master FileII. Device Master File

1. Executive summary

2. Device Description and product specification, including variants and accessories

Device Description Product Specification Reference to predicate and/or previous generation

of the device

3. Labeling

4. Design and Manufacturing information Device Design Manufacturing Processes

5. Essential Principal ChecklistAccredited Consultants Pvt. Ltd.

6. Risk Analysis and control Summary7. Product Verification and validation General Biocompatibility Medicinal Substance Biological safety Sterilization Software Verification and validation Animal Studies Shelf life/Stability Data Clinical Evidence Post Marketing Surveillance DATA (Vigilance reporting)


III. LABELS AND INSERTSIII. LABELS AND INSERTS

Product labels should show the address of Manufacturer.

Product inserts should describe the brief description of the product and its intended use.


PROCESSING PROCEDUREPROCESSING PROCEDURE After ensuring all documents correctly as per therequirements of FDA, they are submitted. It generally takes about 4-5 months to scrutinize

these documents by Technical Data Associates/Drug inspectors of CDSCO.

During this period clarification if any, are required by them are answered.

Thereafter we get the Renewed Registration Certificate (RC).


IMPORT PROCESSINGIMPORT PROCESSING After getting the registration certificate from CDSCO,

the Indian agent is now import the products from the manufacturer. Following documents are further required to get Form 10 (Import license).

Form 8 TR Challan- (Rs 1000 for Ist. product then Rs 100 for

each additional product)Form 9Copy of Wholesale License (Indian agent)-NotarizedCopy of Registration Certificate-Notarized


TIME LINE FOR IMPORT LICENSETIME LINE FOR IMPORT LICENSE The Importer (Indian agent) is not authorized to import

the products from foreign manufacturer unless he obtains Import license (Form 10) form CDSCO.

It generally takes about one month to scrutinize thesedocuments by Technical Data Associates/Drug inspectorsof CDSCO and during this period clarification if any, arerequired by them are answered and thereafter the importergets the Import license. For Import license application TR Challan of Rs 1,000.00[INR One Thousand only] for First product then Rs 100.00for each additional product isrequired.


Contact DetailsContact DetailsAddress:Accredited ConsultantsPrivate Limited,D-29, First Floor,Acharya Niketan, Mayur Vihar Phase-I, Delhi-110091.Telephones:Landline: 011-22758204, Mobile: +91-9310040434,

+91-9266665201

Fax: 011-22758994

Email: [email protected] [email protected]@acplgroupindia.co.in Websites:www.apclgroupindia.co.in www.apclgroupindia.com

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