The Indian drug regulatory system which was formed in 1940, created Drugs & Cosmetics rule The Drug rules were been framed in 1945 to give effective support to the Drugs & cosmetic Act. This two Act and Rules been amended several times, and various legislative texts were passed to regulate the import, manufacture, distribution and sale of drugs in India.
The regulatory process in India is composed of several important stake holders in the fields of biotechnology, biomedical sciences, agriculture, health care, animal sciences and environment Thus, the Indian drug regulatory system is divided into central (federal) and state (provincial) authorities.
In recent times India has emerged as a Major supplier of Medical products globally. The medical device industry is a multiproduct industry, manufacturing a wide range of products. India medical market is growing as a key market for medical devices and diagnostics. Early, these medical device have not been regulated but according to the amended Drugs & Cosmetics Act 1940, in 2006 Central Drugs Standard Control Organization (CDSCO) stated Medical products need to be regulated under Medical device Rule 2017. Thus CDSCO will also regulate the import, manufacture, distribution and sale of medical device.
The aim of CDSCO is to safeguard and enhance public health by assuring the safety, efficacy and quality of drugs, cosmetics and medical devices. CDSCO also monitors the quality of imported medical devices at the port offices by Central licensing Authority and State Licensing Authority. While there is a specific list of regulated products, CDSCO Occasionally adds new products to the lists and also changes the regulatory system in India. This article gives an overview of the new regulatory system in India.
New Regulatory system that is been published by Central Drugs Standard Control Organization (CDSCO) has set of new guidance documents or legal documents for registration and re-registration for the notified medical devices. These legal documents have been framed on the basis of Medical device rule 2017, which effectively came to force on 1st January 2018.
CDSCO Guidance Document for new registration after 2018:
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Regulatory Dossier is applied in MD 14
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Registration is obtained in MD 15
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Predicate: Predicate is one of the important things under this Registration process, having predicate device available locally in India is Must, without predicate CDSCO process delays and becomes tedious. If predicate is not available, it need to be applied in different Dossier in MD 26/Registration is obtained in MD 27
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Regulatory documents to be applied in MD 14 dossier:
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MD 14
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TR6 Challan
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Power of Attorney
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Schedule D(II) or Device Master File
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ISO 13485 certificate
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Full Quality Assurance Certificate
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CE design certificate
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Declaration of Conformity
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Free sale certificate
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Batch release certificate
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PMS report
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Plant Master File/quality manual
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Business licence/Plant registration certificate
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Audit report
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Constitution details (Indian agent)
4. Power of Attorney documents includes Medical device generic and model names as well as shelf life information must now be included, which helps to solve the existing model amendment can be made before importing it into India.
5. Documents submitted to CDSCO must be valid for at least six month following their submissions
6. Documents that is been submitted must specify legal and manufacturing site names and addresses along with product names, generic names and model name as necessary.
CDSCO Guidance Document for Re-registration after 2018:
- CDSCO has also included guidelines for Re-registration. Re-registration process must have an additional attachment of old Registration certificate MD 41.
- No change in Plant master file and No change in Device master file also need to submitted
How Morulaa helps in new registration and Re-registration Process?
- Morulaa team constantly works with the expertise team and fine tunes the process that is carried smoothly and ensures to be soon registered with in our Indian market.
- Morulaa also consistently supports for the import activities carried after Registration