CDSCO Guideline Approved for Medical Devices Safety & Performance

CDSCO Guideline Approved for Medical Devices Safety & Performance

CDSCO Guidelines for Medical Devices Safety and Performance

CDSCO guidelines approved under the Central Drugs Standard Control Organization (CDSCO) is the Central Drug Authority for discharging functions assigned to the Central Government under the Drugs and Cosmetics Act. One of the major functions of CDSCO is the approval of new drugs in the country. During the month of March 2018, the CDSCO guideline was approved on the following issuance of the CDSCO guidelines under the provisions of the Medical Devices Rules, 2017 on Essential Principles for Safety and Performance of medical devices CDSCO.

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As per CDSCO guidelines if a person or firm wants to import the devices they need to apply for a CDSCO import license and if a person/firm wants to manufacture medical devices then they need to obtain a CDSCO manufacturing license. Both the licensing process needs correct documentation. Recently CDSCO issued guidance for the  mandatory registration of medical devices, so one needs to consult with the medical devices consultant to speed up the registration process with CDSCO

The new medical device rule “MDR 2017, India” has come into result from January 2018. Under control with that, the CDSCO (Central Drug Standard Control Organization) has recently been releasing guidance papers, CDSCO guideline reports, and various other important updates to allocate unalterable guidance for use in the manufacturing and registration of medical devices which are planned to be sold in India. Just like that, CDSCO has released a new draft guidance document, which concisely highlights the essential principles for the safety and production of various medical devices (MDs) based on rule 6 of MDR 2017.

Normally there are 3 levels of the standard used to meet the medical devices’ essential principles for safety and performance. These need to be examined as a whole i.e. basic standard, group standard, and product standard. Basic standards are standards specifying elemental concepts, principles, with consideration to general safety which is relevant to a wide range of products, whereas group standards consist of features applicable to families of similar products making reference as far as possible to basic standards. Eventually, product standards indicate the requisite safety and performance of specific products making reference as far as possible, to basic standards and group standards.

It is essential to mention that IVD medical devices have been divided from medical devices in the new rule although the classification for each type follows class A, class B, class C, and class D categories. There are some important principles declared for all MDs including IVDs and some important principles for MDs except IVDs whereas some are substantially made for IVDs.

Important principles for all classes of MDs mostly highlight the fact that they should be planned and manufactured in such a way that they will perform as intended by the user without compromising the clinical conditions and safety of patients. Every medical device needs clinical evidence, appropriate for its intended use and categorization of the medical device, demonstrating that the device follows with the applicable provisions of the important principles.

As per Cdsco Guideline Imminent to the Product Standards of MDs Care Should Be Taken During Manufacturing Keeping the Following Aspects in Mind i.e.

(1) Chemical, physical and biological properties.

(2) Infection and microbial contamination.

(3) MDs incorporating materials of biological origin.

(4) Environmental properties

(5) Performance evaluation

(6) Protection against radiation

(7) MDs that incorporate software and standalone medical device software

(8) Active devices

(9) Protection against mechanical and thermal risks

(10) Performance evaluation including analytical performance and, where suitable, clinical performance.

For IVD medical devices above points still, hold along with some additions related to the use of reagents or bimolecular. For new IVDs, clinical evaluation studies using specimens from human subjects should be carried out according to the CDSCO guideline.

Our experienced team of medical device regulatory consultants provides guidance for the CDSCO medical device registration process as per the guidelines. Also, provides medical device QMS services with ISO 13485 certification and 21 CFR part 820. for any query on this, you can contact us.

FAQ

Where to apply for a medical device import license?

For the licensing is regulated by the Ministry of Health and family welfare in the central government. The ministry has verified the CDSCO registration online portal through which the import license has to be made. The application is made to the central licensing authority using Form MD-14. The applicant should also submit some other documents along with the application Form for verification. Firstly the application must have a cover letter in a proper format having proper details for the application. The applicant needs to submit a valid manufacturer license of an Indian agent for medical devices. This is an important condition for filling out an application.

which license is required to sell medical devices in India?

Before the introduction of a new medical device in the Indian market, the manufacturer has to accept certain regulations. If a sole person wants to import a new medical device, a license for the manufacturer of the product is necessary. The Central Drugs Standard Control Organization known as the (CDSCO) is a regulatory body, for the Indian medical devices industry, under regulatory provisions of the Drugs & Cosmetics Act 1940 & 1945. CDSCO is the national regulatory body for the Indian medical device industries and pharmaceutical industries. It is the licensing authority that approves any new medical device import to India. The Indian CDSCO is controlled and governed by the Directorate General of Health Services which comes under the Ministry of Health and family wealth government of India. The CDSCO regulations are responsible for the registration and sale of notified medical devices in India.

How to get a medical device registered in India?

To launch a medical device, the manufacturer has to adhere to numerous norms set by way of the countrywide regulatory bodies of India. The number one regulatory frame for medical devices in India is the central drugs trendy control organization (CDSCO). The applications for all elegance of scientific gadgets are made to the important licensing Authority (CLA) in which the Drug Controller General of India (DCGI) takes obligation for the approval of manufacturing, registration, import, and sale of medical devices in India. The medical devices might also or won’t want to be registered before the sale. While there may be no want for registration, the producer must gain a no-objection certificate (NOC) from the DCGI before releasing the product inside the marketplace. Whilst the medical device to be launched is imported, it has a fixed of issued steps to be observed like filling out a registration form at the side of the fees. The form will include the applicant’s and manufacturer’s details, product facts, the regulatory fame of the product, info on good manufacturing practices included, and publish-marketing surveillance at the side of an assignment shape. The retailers, stockiest, and importers shall also gain the respective sale licenses from the national Licensing government (SLA). The National Licensing Authority is responsible for the control and enforcement of regulations related to the sale, stock, and providing on the market of medical devices in India.

Does medical device import require a license from Indian FDA?

Yes. Under the provision of the Drugs and Cosmetic Act 1940, CDSCO registration and import license are required to import Medical Devices in India. For the introduction of medical device in the Indian market, the Manufacturers has to obey various norms set by national regulatory bodies of India. The main regulatory body for medical device in India is Central Drugs Standard Control Organization (CDSCO). The Application for all classes of medical devices as per cdsco guidelines are submitted to Central Licensing Authority, where the (DCGI) Drug Controller General of India takes the responsibility for approval of Manufacturing, Registration, Import and Sale of Medical Devices in India. When the Medical Device released to be imported it has some issued steps to be followed. Only those medical devices require import license which are listed in Notified medical devices by CDSCO.

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