Medical device registration in India
In India import, manufacturing, sale and distribution of medical devices is regulated as Indian MEDICAL DEVICES RULES 2017, under Drug & cosmetic act.
Two authorities are responsible for issuing certification- CDSCO (for class C & D products) and the State licencing authority (For class A & B products).
- Process:
1.1 Classification of medical devices as per IMDR.
1.2 Implement QMS System.
1.3 Compliance to statutory & Regulatory requirements.
1.4 Technical files for Products.
1.5 Audit carried out by licensing authority (Notified Body).
1.6 Certification
- Documents required for registration of medical devices in India
| Sr.No. | Documents Name |
|---|---|
| 1 | Covering letter along with payment of application fee. |
| 2 | Self-Assessed check list of documents |
| 3 | Authorization letter |
| 4 | Form 40 |
| 5 | TR6 Challan |
| 6 | Plant master file |
| 7 | Device master file |
| 8 | Manufacturing license |
| 9 | Free sale certificate |
| 10 | IFU & Device label |
1. Authorised agent” (Authorised representative) means a person including any firm or organisation who has been appointed by an overseas manufacturer through a power of attorney to undertake import of medical device in India.
2. “licence” means a licence granted by the State Licensing Authority or the Central Licensing Authority in Form MD-5, Form MD-6, Form MD-9, Form MD-10, Form MD-15, Form MD-17 or Form MD-19
3. Application for manufacture for sale or for distribution of Class A or Class B medical device. — (1) Any person who intends to manufacture a Class A or Class B medical device including in vitro diagnostic medical device shall make an application for grant of licence or loan licence to manufacture for sale or for distribution to the State Licensing Authority.
4. Application for manufacturing Class C or Class D devices.— (1) An application shall be made to the Central Licensing Authority through an identified online portal of the Central Government for licence or loan licence to manufacture for sale or for distribution, as the case may be, of Class C or Class D medical device in Form MD-7 or Form MD-8, respectively.
5. Application for grant of import licence.— (1) An authorised agent having licence to manufacture for sale or distribution or wholesale licence for sale or distribution under these rules, shall make an application for grant of import licence for medical device to the Central Licensing Authority through an identified online portal of the Ministry of Health and Family Welfare in the Central Government in Form MD-14 for obtaining a licence.
6. Registration fees-
| Sr.No. | Subject | Fees |
|---|---|---|
| 01 | Manufacturing licence or loan licence to manufacture Class A or Class B medical device for one site. | 5000 INR |
| 02 | Manufacturing licence or loan licence to manufacture Class C or Class D medical device for one site. | 50000 INR |
| 03 | Import licence for Class A medical device other than in vitro Diagnostic medical device for one site. | $1000 |
| 04 | Import licence for Class B medical device other than in vitro diagnostic medical device for one site. | $2000 |
| 05 | Import licence for Class C or Class D medical device other than in vitro diagnostic medical device for one site. | $3000 |
| 06 | Certificate to export of each distinct medical device | 1000 INR |
