Services Details

Cosmetics & Medical Approvals

Central Drugs Standard Control Organization

Cosmetics

Import - No cosmetic shall be imported into India unless the product has been registered in accordance with Cosmetics Rules, 2020 by the Central Licensing Authority. An application for registration of a cosmetic product intended to be imported into India shall be made in Form COS- 1 either by the manufacturer himself or by his authorized agent or the importer in India or by the subsidiary in India authorized by the manufacturer

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The Central Licensing Authority may, on being satisfied, grant import registration in Form COS- 2 or may reject such application.

In case of a new cosmetic, the applicant shall obtain prior permission in Form COS- 3 as provided in Chapter V from the Central Licensing Authority before registration of import of new cosmetic into India.

No cosmetic, the manufacture, sale or distribution of which is prohibited in the country of origin, shall be imported under the same name or under any other name except for the purpose of examination, test or analysis.

MANUFACTURE OF COSMETICS FOR SALE OR DISTRIBUTION - Any person who intends to manufacture cosmetics shall make an application for grant of a license or loan license to manufacture for sale or for distribution in Form COS- 5 for license or in Form COS- 6 for loan license.

In case of a new cosmetic, the applicant shall obtain prior permission in Form COS- 3.

If cosmetics are manufactured at more than one premises, a separate application for each of such premises shall be made and a separate license obtained for each such premises.

A license or loan license to manufacture cosmetics for sale or distribution shall be granted in Form COS- 8 and loan license in Form COS- 9.

PERMISSION FOR IMPORT OR MANUFACTURE OF NEW COSMETIC - Any person who intends to import or manufacture a new cosmetic, shall apply to the Central Licensing Authority in Form COS- 12. The Central Licensing Authority, after being satisfied that the cosmetic if permitted to be manufactured or imported shall be safe and effective for use in the country, may issue a prior permission in Form COS- 3.

India Compliance & Testing Laboratories, an experienced CDSCO consultant firm are here to help you in obtaining CDSCO certification with simplicity. Our expert CDSCO consultants will assist you at every step from product evaluation, testing to extensive documentation for the CDSCO certification.

Product Categories

Product Categories

Product Categories

1- Face care products other than face mask 31- Eye shadow 58- Other hair styling products
2- Face mask 32- Eye pencil 59- Hair sun protection products
3- Eye contour products 33- Eye liner 60- Other hair and scalp products
4- Lip care products 34- Other eye make-up products 61- Nail varnish / Nail make-up
5- Hand care products 35- Lip stick 62- Nail varnish remover
6- Foot care products 36- Lipstick sealer 63- Nail varnish thinner
7- Body care products 37- Other lip make-up products 64- Nail bleach
8- External intimate care products 38- Body or face paint, including "carnival make-up" 65- Other nail varnish and remover products
9- Chemical exfoliation products 39- Other make-up products 66- Nail care products
10- Mechanical exfoliation products 40- Hydro alcoholic perfumes 67- Nail hardener
11- Skin lightening products 41- Non hydro alcoholic perfumes 68- Other nail care / nail hardener products
12- Other skin care products 42- Before and after sun products Sun protection products 69- Nail glue remover
13- Soap products 43- Self-tanning products 70- Cuticle remover / softener
14- Bath / shower products 44- Other sun and self-tanning products 71- Nail sculpting products
15- Make-up remover products 45- Other skin products 72- Other nail and cuticle products
16- External Intimate hygiene products 46- Hair conditioner 73- Toothpaste
17- Other skin cleansing products 47- Scalp and hair roots care products 74- Tooth cleansing powder / salt
18- Chemical depilatories 48- Anti hair loss products 75- Other tooth care products
19- Physical epilation products 49- Other hair and scalp care and cleansing products 76- Mouth wash
20- Other body hair removal products 50- Antidandruff products 77- Breath spray
21- Bleach for body hair 51- Oxidative hair colour products 78- Other mouth wash / breath spray products
22- Products with antiperspirant activity 52-Non-oxidative hair colour products 79- Tooth whiteners
23- Products without antiperspirant activity 53- Hair bleaching and dye remover products 80- Other oral hygiene products
24- Shaving products 54- Other hair coloring products
25- Pre-/ after-shaving products 55- Products for temporary hair
26- Other shaving and pre- / after- shaving products 56- styling Permanent wave products
27- Foundation 57- Hair relaxer / straightener products

Medical Approvals

Medical devices including in vitro diagnostic medical devices are classified in the following classes: —

(i) low risk - Class A

(ii) low moderate risk - Class B

(iii) moderate high risk - Class C

(iv) high risk - Class D.

Medical devices along with in Vitro medical devices, being imported or manufactured, require permission from CDSCO. The approval is given by CDSCO’s State Licensing Authority (SLA) or the Central Licensing Authority (CLA).

Applicable Licenses

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Forms

Application Type

1

Form MD-3

Application for Grant of License to Manufacture for Sale and Distribution of Class A or Class B medical device

2

Form MD-4

Application for Grant of Loan License to Manufacture for Sale or for Distribution of Class A or Class B medical device

3

Form MD-5

License to Manufacture for Sale or for Distribution of Class A or Class B Medical Device

4

Form MD-6

Loan License to Manufacture for Sale or for Distribution of Class A or Class B medical device

5

Form MD-7

Application for Grant of License to Manufacture for Sale or for Distribution of Class C or Class D

6

Form MD-8

Application for Grant of Loan License to Manufacture for Sale or for Distribution of Class C or Class D

7

Form MD-9

License to Manufacture for Sale or for Distribution of Class C or Class D

8

Form MD-10

Loan License to Manufacture for Sale or for Distribution of Class C or Class D medical device

9

Form MD-14

Application for issue of import license to import medical device

10

Form MD-15

License to Import Medical Device

11

Form MD-41

Application for Grant of Registration certificate to sell, stock, exhibit or offer for sale.

12

Form MD-42

Registration Certificate to sell, stock, exhibit or offer for sale.

India Compliance & Testing Laboratories, an experienced CDSCO consultant firm are here to help you in obtaining CDSCO certification with simplicity. Our expert CDSCO consultants will assist you at every step from product evaluation, testing to extensive documentation for the CDSCO certification.

Regulated Product Categories

Device Name Device Name
1-Disposable Hypodermic Syringes 19- Condoms
2-Disposable Hypodermic Needles 20- Tubal Rings
3-Disposable Perfusion Sets 21- Surgical Dressing
4-In vitro Diagonostic for HIV, HbsAg & HCV 22- Umbilical Tapes
5-Cardiac Stents 23- Blood/ Blood Component Bags
6-Drug Eluting Stents 24- Disinfectant.
7-Catheters 25- Nebulizer
8-Intra Ocular Lenses 26- Blood pressure monitoring device
9-I.V. Cannulae 27- Digital Thermometer
10-Bone Cements 28-Glucometer
11-Heart Valves 29- All Implantable Medical Device
12-Scalp Vein Set 30- MRI Equipment
13-Orthopedic Implants 31- CT Scan Equipment
14-Internal Prosthetic Replacements 32-Dialysis Machine
15-Ablation Devices 33- PET Equipment
16- Blood Grouping Sera and Substances for In Vitro Diagnosis 34- X Ray Machine
17- Ligatures, Sutures and Staplers 35-Defibrillator
18- Intra Uterine Devices (Cu-T) 36-Bone Merrow Cell Seperator
37-Ultrasound Equipment