An overview of CDSCO approval process for registration of Medical Devices, Cosmetics, IVD’s and Drugs in India.

At the federal government level, all notified medical products are regulated by the Central Drugs Standard Control Organization (CDSCO) under the Ministry of Health and Family Welfare. The responsibility lies with the Drugs Controller General of India (DCGI) under the CDSCO (can be referred to Indian FDA) for license or product approval. The CDSCO is responsible for approval and regulation of New Drugs and Clinical Trials in the country, laying down the standards for Drugs, control over the quality of imported Drugs, coordination of the activities of State Drug Control Organizations and providing expert advice with a view of bring about the uniformity in the enforcement of the Drugs and Cosmetics Act. Manufacturers can leverage their approvals in the US, Canada, Europe, Australia or Japan for the Registration process in India.

Medical Devices:

Earlier, manufacturers could sell medical devices in India without any jurisdictions. Since 2006, medical devices entering India must be in compliance with the Indian Medical Device Regulation has been set by the CDSCO (Indian FDA). In India, for marketing of imported medical devices which comes under the notified category, Registration Certificate in Form-41 and Import License in Form-10 are required under the regulation of Drugs and Cosmetics Act, 1940.

For Medical Device Registration in India, 21 devices categories have been listed as ‘Notified Medical Devices’ by the CDSCO. However, devices which require registration approval process from the CDSCO extends beyond the listed. A team of regulatory consultants specialized for medical devices at Morulaa can assist in determining whether your medical device requires regulatory license in India. Medical devices which undergo regulatory approval process in India include spinal needles, cochlear implants, annuloplasty rings, trachestomy tubes, syringes and needle, dental implants, surgical sealants, heart valves, cardiac stents, orthopedic implants, endotracheal tubes, and catheters, among others – Full List of Notified Medical Devices in India.

Time Line and Validity

The time period for Registration of Medical Devices in India is generally 6-9 months, post the submission of complete and accurate regulatory dossier and fees to obtain the registration / license. Registration is valid for 3 years and renewal applications (re-registration) need to be submitted 6 months in advance of expiry of the registration certificate.

Study in DetailMedical Device Registration in India

Cosmetics

For the import of cosmetics into India, the cosmetic products need to be registered with the licensing authority as defined under Rule 21 of Drugs & Cosmetic Rules. The regulatory application needs to be submitted in Form 42 along with Soft copies of the information about the brands, products and manufacturer, product specification and testing protocol to receive the cosmetics registration certificate in Form 43.

A list of documents including Schedule D III, shall be submitted to CDSCO. The full list of documents required for submission and the labeling requirements for importing cosmetics into India is explained in Step by Step process of Cosmetic Registration.  The Cosmetics that are supposed to be imported are categorized into Brands. These brands are divided into 4 main category namely Skin products, Hair and scalp products, nail and cuticle products and Oral hygiene  products.

Time Line and Validity

The cosmetic product approval license in Form 43 will issued within 6 six  by CDSCO from the time of submission of regulatory application provided all documents are proper. However, as per a notification in 2014, the targeted timeline for cosmetics regulatory approval process is 90 days.  Like Form 41 (medical device license), cosmetic license is also valid for 3 years unless its suspended or cancelled sooner.

Study in DetailCosmetics Registration in India

In Vitro Diagnostics Kits

IVD kits/reagents are classified into 2 category as Notified and Non-notified IVD products. The Notified products are  “In-Vitro Diagnostic Devices for HIV, In-Vitro Diagnostic Devices for HBV, In-Vitro Diagnostic Devices for HCV and In-Vitro Blood grouping sera”. All In-Vitro Diagnostic kits and Reagents excluding those notified category would be covered under the category of Non-Notified IVD products. 

For the Registration of In Vitro Diagnostics Kits in India, Registration Certificate in Form-41 would be required in case of notified IVDs and Import License in Form-10 in case of non-notified IVDs under Drugs and Cosmetics Rules. This guidance documents has been prepared to specify the general requirements for grant of registration certificate in Form-41. A Test License in Form 11 and Performance Evaluation report would be required before the registration application of IVD products.

Time Line

The validity of a Form 11(Test License) is one year unless its sooner suspended or cancelled. Registration certificate od IVDs is valid for 3 years.

Study in Detail IVD (In-Vitro Diagnostics) Registration in India

CDSCO Regulatory Challenges  in India

Manufacturers of medical devices, cosmetics, IVDs are attracted to the Indian market due to its reliance on imports. However the challenge is that the Regulatory Body in India is currently at its infancy and rules may be updated within short periods resulting in uncertainty over the approval process.

The general timeline followed by the CDSCO for the various process of approval, trials, applications can be found – CDSCO Timelines. Contact Harshita Gupta for additional consultation or information. Morulaa HealthTech as successful regulatory consultants has delivered high level professionalism and quality towards our clients.

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