Général
|
| Pays |
India |
| Région géographique: |
South-East Asia |
| Le niveau de revenu (Banque mondiale ): |
Lower middle income |
| Population (women 15-49 years) in millions, 2015: |
331,9 |
| Are condoms (male/female) regulated in the country? |
yes |
| If yes, describe the applicable regulation or directive: |
" The Standard for mechanical contraceptive (condom) shall be such as are laid down in Schedule R of Drugs & Cosmetics Act 1940; " |
| Condom classification (medical device, medicines, others): |
Regulated as 'drugs' and included in the Notified Medical Device list |
| National competent (regulatory) authority: |
"CDSCO (Central Drugs Standard Control Organization) Under Directorate General of Health Services, Ministry Of Health & Family Welfare " |
Essential Medicines List
|
| Condoms on EML? |
yes |
| Female condoms specified on EML? |
yes |
| EML Version (year): |
2011 |
Registration Requirements
|
| Applicant eligibility: |
Appoint an India Authorized Agent to interact with the CDSCO on your behalf. Agent must have a valid wholesale |
| Administrative documents: |
"Cover letter; Letter of authorisation issued by the India agent firm; Completed application form (form 40); Power of attorney issued by the manufacturer" |
| Technical documents: |
"Wholesale license; Manufacturing license; Free sale certificate; ISO certificate 13485:2003; CE Design Examination certificate; Declaration of conformity; Schedule DI and Plant Master File; Schedule DII and Device Master File " |
| Sample: |
"Exhibits & reference sample 90 units & Test sample 100 units (25+75) if any. Sample of label & notarised instruction for use (IFU) " |
| Timeline: |
"6 to 9 months for CDSCO to issue Registration Certificate. It usually takes 4 to 5 weeks to obtain an Import License " |
| Registration Fee: |
"$1,500 for registration of manufacturing premises & $1,000 for single device, plus $1,000 per additional device to be imported to India " |
| Validity of registration: |
"Registration Certificates (Form 41) and Import Licenses (Form 10) are valid for 3 years " |
