Things you must know about Medical Device Registration India and Pharma CTD dossier

by Varsha Gaur teacher

If an individual wants to introduce a new medical device regulation india or wish to manufacture any regulated device, then it is required by the individual to abide by medical device rules (MDR, 2017). In this article, we will discuss the medical device regulations and the importance of Pharma CTD dossier for drug regulation.

After the publication of MDR 2017, the government of India has finally released some clearly defined rules for a medical device in India that came into effect from January 1, 2018.

Let's have a look at some of the important points for medical device regulation. These rules are applicable in respect of :

·       substances used for in vitro diagnosis and surgical dressings, surgical bandages, surgical staples, surgical sutures, ligatures, blood, and blood component collection bag with or without anticoagulant covered under sub-clause (i);

·       substances including mechanical contraceptives (condoms, intrauterine devices, tubal rings), disinfectants and insecticides notified under sub-clause (ii); and

·       devices notified from time to time under sub-clause (iv)of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940 (23 of 1940).

Now coming to the dossier, you must know what is Dossier?

The word “Dossier” has its English meaning as - a collection or file of documents on the same subject, especially a file containing detailed information about the person or a topic.

Registration Dossier” of the pharmaceutical product is a document that contains all the technical data (administrative, quality, nonclinical and clinical) of a pharmaceutical product to be approved/registered/ marketed in a country

Pharma CTD dossier is one of the best choices of the healthcare industry for controlling regulatory affairs services in India. It provides assistance on various regulatory aspects in the pharmaceutical industry and all other industries where regulations are consistently undergoing evolution. The CTD format influences the content of the review by imposing a consistent order of information and data. This shapes both the conduct of the review and the presentation of the results of the review and promotes good review practices and increased efficiencies.

This ASEAN Common Technical Dossier (ACTD) is a guideline of the agreed upon common format for the preparation of a well-structured Common Technical Dossier (CTD) applications that will be submitted to ASEAN regulatory authorities for the registration of pharmaceuticals for human use.ACTD Dossier compliance helps a lot in the documentation of Pharma regulatory services. In addition to that the regulatory affairs, laboratory classification, regulatory affairs consultation product, medical and lingual translation, advertisement approvals, manufacturer registration and product registration are well taken care of.

The pharmaceutical industry is vast and extends to a greater extent in the world. The drug regulatory agencies need Pharma CTD dossier to get the approval for drug marketing. The Pharma dossier consists of varied documents that represent the number of research years. These researches involve multi-discipline information about safety and drug efficiency.

Management of Pharma CTD Dossier

The regulatory process and the dossier submission require several communications between the company that approaches for submission and the regulatory authority. This is the reason, why the effort of gathering the documents and then presenting in a compliant format depends on the sponsor's shoulders. The whole process is very complicated that requires high costs and needs management of various components and documents during the process of approval.

Thus, we can say that pharmaceutical dossier is one of the detailed documents of drugs that need exclusive data on several aspects. The compilation of data needs various skills of sourcing, interpreting and document writing. The whole process of Pharma dossier requires an expert team of a data analyst, pharmacist as well as research assistants. It is time taking as well as expensive. So, it's better to shoulder this responsibility on Consultants who have expertise in Dossier Compilation and submission.

Conclusion: Thus, it is concluded that it is out most important to follow rules and regulation before introducing any new product in the market.

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About Varsha Gaur Freshman   teacher

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Joined APSense since, May 23rd, 2019, From New Delhi, India.

Created on Jun 21st 2019 06:37. Viewed 295 times.


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