IMPORT OF MEDICAL DEVICES IN INDIA
For the purpose of import of Medical Devices in India , the procedure for registration and import licence as prescribed under the Drugs and Cosmetics Rules is followed.
REGISTRATION OF MEDICAL DEVICES FOR IMPORT
1. 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.
2. 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.
3. 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.
4. The fee shall be paid through a challan in the Bank of Baroda as prescribed under the said Rules.
5. 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.
On grant of RC Certificate , import license is applied by the Importer.
(A) Applicant Details
1. Applicant’s company name, address and contact number.
2. Name and address of foreign manufacturer (Manufacturing premises).
3. Copy of the Plant Master File.
4. Name and address of the local authorized representative.
5. Name and address of the importer.
6. Local manufacturer, if any processing is being done in the country.
(B) 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 the constituents.
7. Brief description of the method of the manufacture and specification of the materials used.
8. Contraindications, warnings, precautions potential adverse events and alternate therapy, wherever applicable.
9. 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.
10. Variations in shape, style or size of the device, if applicable.
11. Labeling details conforming to Drugs and Cosmetics Rules, 1945.
12. Physician manual and promotional literature (Literature insert) in English.
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
(C) Regulatory Status
1. Approval of the product from any other regulatory agency (Separate evidence for the approval from the each agency)
(i) US FDA clearance/approval.
(ii) EU medical device directive (CE Certificate).
(iii) Australia/Canada/Japan approval.
(iv) Approval in any other country.
1. Copy of ISO/EN Certification if any for the manufacturing facility.
2. List of countries where the device is being sold.
3. List of countries where device is withdrawn from sale with reasons,