The CDSCO is to safeguard and enhance public health by assuring the safety, efficacy and quality of drugs and medical products that is been registered within India. In India 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. Medical device is not been regulated since 2006 later CDSCO has notified certain medical device to be regulated. So under this CDSCO has generated a process of submission of regulatory documents which is internally reviewed by CDSCO expertise team. This Regulatory document consists of many and one most important document is predicate device. This article explains about the importance of predicate.

To Register the Product in India we need to determine whether a specific device requires registration or not. They are two types of device that is been notified by CDSCO, notified Medical devices, non notified medical devices. Only the notified medical devices come under the regulation that is specified in the Drug and cosmetic Act 1940. Some of the medical devices are regarded as “Drugs” under Drugs & Cosmetics Act 1940 & Rules 1945 which are also termed as non-notified medical devices. The list of notified device is also currently revised by CDSCO.

Some devices that are not mentioned in the above list of the notified medical devices are required to undergo registration process with CDSCO. It is often recommended in the cases where manufacturer is unclear about the regulatory status of their product in India, to review their device application by Drugs Controller General of India (DCGI) and obtain a No Objection Certificate (NOC). The CDSCO after examining the product information and other related documents will issue a written statement on the regulatory status of the products. The process will take about 4 to 12 weeks for the CDSCO to review the application and issue the NOC.

Importance of Predicate Device:

Importance of predicate and choosing the right predicate device from India is very important and need to be updated to Central drug standard and control organization CDSCO, through which the authority determines the product efficacy.

The time for registration process can take anywhere between 6 to 9 months. If the products do not have a predicate in India the processing time will increase and special committee will be appointed to determine the products’ safety and efficacy for the Indian market.

Predicate comparison which has been submitted to CDSCO must have similar Product description, Intended use, design, Material of construction, Advantage and disadvantage, Contraindication which are all need to be similar when compared with product that need to be registered, so while working with predicate information these are some basic overview that need to be worked for.

The classification of device from CDSCO which generally classifies the Product as CLASS A, CLASS B, CLASS C and CLASS D according to the risk involved in usage of the product. Product Code is another important category in finding the predicate device, whether they have already registered with CDSCO

Classification of the device and product code is essential in searching for predicate devices. Classification of your device can be found by performing a search on the Product code and classification database. This classification database provides the Common name, product code, Registration number, manufacturer information, Indian agent details. Thus, knowing the information of predicate available in India which further needs to be worked for sending to CDSCO.

Importance things noted when No Predicate device found in India:

If the product does not have predicate device available in India then we should apply in FORM MD 26. A special investigation team set by CDSCO reviews this in all aspects especially they are very much keen about the clinical investigation carried out by the manufacture.

Provided further that in respect of investigational medical device of Class A, data on clinical investigation

may not be required, except in cases, where depending on the nature of the medical device,

Provided also that subject to other provisions of these rules, in case of medical device of which drugs are

also a part, the submission of requirements relating to animal toxicology, reproduction studies, teratogenic studies, perinatal studies, mutagenicity and carcinogenicity may be relaxed in case of drugs already approved and marketed in India and supported by adequate published evidence regarding safety of the drug.

Provided also that, the results of clinical investigation may not be required to be submitted where the

investigational medical device is approved by the regulatory authorities of either the United Kingdom or the United States of America or Australia or Canada or Japan and the said device has been marketed for at least two years in that country and the Central Licencing Authority is satisfied with the data of safety, performance and pharmacovigilanceof the device, and,-

(a) there is no evidence or theoretical possibility, on the basis of existing knowledge, of any difference in the behavior and performance in Indian population;

(b) the applicant has given an undertaking in writing to conduct post marketing clinical investigation with the objective of safety and performance of such investigational medical device as per protocol approved by the Central Licensing Authority.

How Morulaa will assist in finding predicate

Morulaa basically have its hands on experience in finding the predicate information. Morulaa has high level internal regulatory team to support in predicate identification; there are many successful registered products in CDSCO with support of Morulaa done consistently.


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