Registration of Medical Devices in India

8/6/2019 Registration of Medical Devices in India

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Registration ofmedical devices in

India

Presented by:

E.Dinesh

B.Pharmacy IV Year

Talla Padmavathi college of pharmacy,Orus, kareemabad, Warangal.

Under the Guidance of

G.Sandeep Gupta

Asst. Professor

Dept. of Pharmacy, TPCP.


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Definition

An instrument, apparatus, machine, contrivance, implant, invitro reagent, or similar or related article, including anycomponent, part, or accessory which is:

recognized in the official National Formulary, or the USPharmacopeia, or supplement to them, intended for use in thediagnosis of disease or other conditions, or in the cure,mitigation, treatment, or prevention of disease, in human oranimals,

or

intended to affect the structure or any function of the body, andwhich does NOT achieve any of its intended purposes throughchemical action within the body of man or other animals and

which is not dependent upon being metabolized for theachievement of any of its principal intended purposes


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The Ministry of Health notifies that the followingsterile devices to be considered as drugs underSection 3(b) (iv) of the Act.

1. Cardiac Stents

2. Drug Eluting Stents3. Catheters

4. Intra Ocular Lenses

5. I.V. Cannulae

6. Bone Cements

7. Heart Valves

8. Scalp Vein Set

9. Orthopedic Implants

10.Internal Prosthetic replacements


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Classification

Medical devices are classified mainly into four classesbased on risk.

Class A

-devices involving lowest risk levelsClass B

- devices involving low to moderate risks

Class C

-devices involving moderate to highrisks

Class D

- devices involving highest risks


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MANUFACTURE OF MEDICAL DEVICES IN THECOUNTRY

1. Application for the grant of licence for manufactureof the notified sterile Devices in the country shall bemade in Form 27 to the State Licensing Authority,accompanied by the requisite fee in the Form and

manner as prescribed in the said Rules along with acopy to the office of DCG(I).

2. A period of 60 days would be provided for making

the application for manufacture from the date ofpublication of these guidelines.


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Continued

3. In case of devices belonging to above said categorieswhich have not been manufactured in the countrybefore the date of notification, no manufacture wouldbe permitted hence forth without the approval of the

competent authority as per norms prescribed.

4. The applicant shall provide the following informationalong with the application for consideration of the

licensing authority


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Manufacturing Details:-

(a) Complete details about the names, addresses of thedirectors of the company and addresses of themanufacturing premises and registered offices of themanufacturer.

(b) A brief project highlight indicating the plans of thecompany, devices to be manufacture, their viabilityand other relevant profiles.

(c) Copy of the Site Master File.

(d) A brief description of the manufacturing process ofthe devices to be manufactured.


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Continued

(e) Details of the standards followed by the companyfor Good Manufacturing Practices and productevaluation.

(f) Name, qualification and experience of technical

staff under whose supervision the devices will bemanufactured.

(g) Copies of ISO or any other certifications, if any,

obtained by the firm for its manufacturing facility.


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Product Details:

A. Proprietary/Brand name.B. Brief description of the device.

C. Category of device.

D. Intended use and method of use.

E. Medical specialty in which the device is used.F. Qualitative and quantitative particulars of the

constituents.

G. Specifications of the materials used.

H. Testing facilities available in the manufacturingpremises for testing.

I. Standards and procedures for testing the device.


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Continued

J. Contraindications, warnings, precautions potentialadverse events and alternate therapy, whereverapplicable.

K. List of accessories and other devices or equipment to

be used in combination with the device. Otherdescriptive information, including accessoriespackaged with the product.

L. Information on stability of the product.

M. Details of clinical trials, (wherever applicable)carried out on the product.

N. Variations in shape, style or size of the device, ifapplicable.


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Continued

O. Labeling details conforming to Drugs and CosmeticsRules, 1945.

P. Physician manual and promotional literature(Literature insert) in English.(if any)

Q. Packaging description including pack sizes.

R. Recommended storage conditions.

S. Summary indications of any reported problems.


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Continued

5. For the purpose of evaluation of Medical Deviceswhich are new or do not have any benchmarkcertification, Expert Committees shall be setup toexamine in detail the information provided by the

applicant for the assessment of the device.6. The committee after completing their assessment

forward the opinion regarding suitability of the deviceto the competent authority for the purpose of grant ofpermission for placing the device in the market.

7. The State Licensing Authority after Joint Inspectionand verification would forward the licence to DCG forapproval.

8. The licence shall be issued in Form 28 of the said

Rules after due approval of DCG.


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IMPORT OF MEDICAL DEVICES

1. A period of 60 days would be provided for theimporters to make application for import andregistration from the date of publication of theseguidelines.

2. In case of devices which have not been imported in

the country before the date of notification no importwould be permitted without the approval of thecompetent authority.


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Continued

3. For the time being and for a period upto six months,until an application is approved or rejected,whichever is earlier, the devices which are currentlyin use will be permitted to be sold. In case of stents or

drug eluting stents the import will not be permitted ifthe applicant has sold less than One thousand stentsof the particular specification prior to the date ofissue of these guidelines.


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Continued

4. Separate committees consisting of subject experts andrepresentative of DCG(I) office would be setup fortheir expert advice for evaluation of specificcategories of devices. The expert committees would

formulate their own benchmarks and procedures forevaluations and the standards to which such devicesshould conform.


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REGISTRATION OF MEDICAL DEVICES FORIMPORT

1. Application for Registration Certificate in respect ofthe premises and the devices manufactured by themanufacturer and meant for import into India isrequired to be made by the manufacturer or importer

or his agent in India, in Form 40 and in form andmanner as under Rule 24A of the Drugs andCosmetics Rules

2. A fee of US$1500 or its equivalent shall be paid

along with the application as registration fee for thepremises where the devices, intended to be importedare being manufactured by the manufacturer.


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Continued

3. A fee ofUS$ 1000 or its equivalent shall be paid forregistration of single Medical Device (which mayinclude variation in sizes or shape without any changein the material or method of use) and an additional

fee US$1000 for each additional device shall be paid.4. The information and undertakings required to be

furnished under Schedule DI and DII may bemodified to suit the requirements of devices in place

of normal pharmacological products. The informationshall include the following details:-


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Applicant Details

1. Applicants company name, address and contactnumber.

2. Name and address of foreign manufacturer(Manufacturing premises).

3. Copy of the Plant Master File.

4. Name and address of the local authorizedrepresentative.

5. Name and address of the importer.

6. Local manufacturer, if any processing is being done

in the country.


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Product Information

1. Proprietary/Brand name.

2. Brief description of the device.

3. Category of device.

4. Intended use and method of use.5. Medicals specialty in which the device is used.

6. Qualitative and quantitative particulars of theconstituents.

7. Brief description of the method of the manufactureand specification of the materials used.

8. Contraindications, warnings, precautions potentialadverse events and alternate therapy, whereverapplicable.

.


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Continued..

9. List of accessories and other devices or equipmentto be used in combination with the device. Otherdescriptive information, including accessoriespackaged with the product.

10. Variations in shape, style or size of the device, ifapplicable

11. Labeling details conforming to Drugs and CosmeticsRules, 1945.

13. Packaging description including pack sizes.14. Recommended storage conditions.

15. Summary indications of any reported problems.

16. Details of standards to which the device conform

alongwith the copy of the standard


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Present scenario

Customs duty is levied on the imported medicaldevices. The duty levied depends on the productclassification and the end user. The products that are

classified by the Ministry of Health as life savingmedical equipment have reduced duty applicable onthem.

Also, the government hospitals/institutions arepermitted to import equipment/devices at a reducedduty. The government hospitals can import at a lowerduty rate only if the product is imported directly fromthe manufacturer. Hence, invoicing and payment ismade directly to the foreign company.


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Regulatory Status

1. Approval of the product from any other regulatoryagency

(i) US FDA clearance/approval.

(ii) EU medical device directive.

(iii) Australia/Canada/Japan approval.

(iv) Approval in any other country.

2. Copy of ISO/EN Certification if any for themanufacturing facility.

3. List of countries where the device is being sold.

4. List of countries where device is withdrawn from salewith reasons, if any.


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Indian market Present Scenario

Indian market for medical devices was largelyunregulated. Medical devices are freely imported intoIndia. The purchaser has to evaluate the quality of theproduct being purchased.

Normally, the FDA approved products are preferredbecause of their better quality and performance. But,India being a price sensitive market, low priced

medical devices find a big market.


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The authority regulating medical devices in India isCentral Drug Standard Control Organization(CDSCO) under the Ministry of Health.

The CDSCO is the authority, which laid down therules, standards and approves import andmanufacturing of drugs, diagnostics, devices, andcosmetics.

CDSCO is the approving authority for import,manufacture and sale of medical devices in India atpresent.


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Conclusion

To ensure the quality of healthcare service, CDSCO isin the process of developing regulations for medicaldevices.

According to industry contacts and the Ministry ofHealth officials, a notification is expected that wouldbring a select group of medical devices under theregulatory framework.


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Registration of Medical Devices in India

Documents

Transcript of Registration of Medical Devices in India