India

General

Country: India
Geographic region: South-East Asia
Income level (World bank): 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 "
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