Senior Regulatory Affairs Executive
4 Years of Experience Medical device regulatory professional specializing in EU MDR 2017/745
International Exhibition of Pharma and Healthcare (iPHEX) on Tuesday.
In a move to improve ease of doing business, India is increasing the validity of the World Health Organisation(WHO) Good Manufacturing Practices (GMP) certificate to three years. The CDSCO WHO GMP certificate was earlier valid for two years, said Drug Controller General of India Eswara Reddy during the 6th annual International Exhibition of Pharma and Healthcare (iPHEX) on Tuesday.
The measure would also result in more product registration for exports, he said, adding that a key demand of the industry has been met.
Likewise, the protocol for clinical trial approvals has also been changed by setting the timeline of approval at 45 days. Once approval does not come within this timeline, the protocol would be deemed to be approved.
Also Read: Parliamentary Panel Recommends Decentralisation of Medical Device Approvals in India.
CDSCO Registration Consultant For Medical Devices
When it comes to CDSCO medical device license process, Operon strategist makes the lengthy process easy and smooth with the best technical team working for you, along with excellent assistance, timely responses and affordable fees structure.
Government is committed to promoting pharmaceutical exports to untapped markets, including China which has agreed for a high-level bilateral roundtable to pave way for Indian pharma to get market access and penetration in their market, commerce and industry minister Suresh Prabhu said during iPHEX.
The US accounts for over 30% of India’s $17.25 billion pharma exports and India has the highest number of US FDA approved plants outside the US, according to data from the Pharmaceutical Export Promotion Council (PHARMEXCIL).”The effort is on to ensure uniform quality. We take it very seriously and want to ensure that consistent quality and efficacy come out of the Indian products” added commerce secretary Rita Teotia. The size of the Indian pharmaceutical industry is expected to increase to $50 billion in the next few years from the present size of $32-33 billion, according to PHARMEXCIL chairman Madan Mohan Reddy.
Operon Strategist will help you with the CDSCO Wholesale and Manufacturing License process.
Also Read: Nephrology and Renal Care Medical Device Registration.
FAQ
Where to apply for 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 Indian agent for medical devices. This is the important condition for filling 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 Indian medical device industries and pharmaceutical industries. It is the licensing authority which approves any new medical device import to India. The Indian CDSCO is controlled and governed by 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 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 of 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 of 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 nation Licensing government (SLA). The nation Licensing Authority is responsible for the control and enforcement of regulations related to the sale, stock, providing on the market of medical devices in India.
Does medical device import require license from Indian FDA?
Yes. Under the provision of Drugs and Cosmetic act 1940, cdsco registration and import license is 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.
Senior Regulatory Affairs Executive | 4 Years of Experience
Medical device regulatory professional specializing in EU MDR 2017/745 technical documentation, CE marking, risk management, clinical and biological evaluation, and post-market surveillance. His expertise includes SFDA MDMA submissions, CDSCO licensing, ISO 13485, MDSAP, US FDA regulatory requirements, and BIS certification.
