Drug and Cosmetic Act mandates Medical Devices manufacturers to avail license from CDSCO from commencing the production undertaking. Medical device licensing with CDSCO is a complicated procedure, and thus it should be pursued under the expert’s supervision. This article discusses the CDSCO Medical Devices Manufacturing Registration Requirement in detail.
General CDSCO Medical Devices are covered under the Drugs and Cosmetics Act
It’s been two years since the Ministry of Health and Family Welfare brought the medical device under the Drugs and Cosmetics Act by including them under the Drug category.
General CDSCO medical devices that can be found under the said legislation include;
- Prosthetic Replacements,
- Digital Thermometers
- Monitoring Machines
- Blood Bags
- Intravenous Cannulae
CDSCO mandates producers and importers of such devices to share the following information for registration purpose.
- Generic name,
- Model number,
- Intended use
- Class of medical device
- Material of construction
- Shelf life and brand name
As soon as the registration is available, the applicant becomes liable to affix the registration number on the licensed devices.
CDSCO Medical Devices Manufacturing Registration Form and other key Requirements
- Applicant seeking a manufacturing license for medical devices needs to approach the state’s drug authority and submit a duly filled application (Form 27) along with the required documentation and fees. Also, the application should be accompanied by a copy to the office of DCG (I).
- The applicant must share the following detail and the prescribed application for consideration by governing authority.
- Complete particulars relating to the company’s directors and the company in question, such as a name, and address.
- Completed details relating to the manufacturer’s registered office.
- A detailed project reflecting the company’s plan, devices to be manufactured, their intended uses and other relevant profiles.
- Copy relating to the Site Master File
- Description relating to the manufacturing process of the proposed CDSCO medical devices
- Details of the provisions followed by the applicant firm for product evaluation and Good Manufacturing Practices.
- Contact and other key details of technical staff accountable for producing medical devices
- Copies of ISO or other relevant certification, if any,
- Proprietary/Brand name.
- Category of device.
- Brief description of the device.
- Intended use and method of use.
- Medical speciality in which the device is used.
- Qualitative as well as quantitative particulars of the constituents.
- Specifications of the materials utilized.
- Testing facilities are present in the production facility for testing.
- Standards and procedures followed by the applicant firm for testing the device.
- Detail relating to contraindications, warnings, and precautions tagged with the medical products.
- List of accessories and other equipment or devices to be utilized in combination with the device. Other key information, including accessories packaged with the medical products.
- Information pertaining to the product’s stability.
- Particulars around the clinical trials conducted on the product.
- Deviation, style, shape or size of the medical device, if applicable.
- Labeling particulars that are in line with Drugs and Cosmetics Rules, 1945
- Physician manual and promotional literature (printed in English), if any
- Packaging description, including pack sizes.
- Recommended storage conditions.
- Detailed report of any reported problems.
- For the vetting purpose of the medical devices which are new or lack any benchmark certification, an expert committee shall be established to vet information shared by the application for the device’s assessment.
- Post completion of the assessment, the committee, shared the opinion regarding the viability of the CDSCO medical devices to the concerned department for the issuance of approval.
- The State Licensing Authority, post collective vetting, shall forward the license to the CLAA for approval.
- The licensing authority shall confer the license in form 28 post due to approval of CLAA.
An overview of Site Master Plan
The site master plan is prepared by the pharmacy company and it encloses details around;
- Quality management policies (including those based on GMP)
- Undertakings of the production facility
- Manufacturing operations
- any closely integrated operations at nearby premises, if any
Site Master File must not contain anything other than specific details. For example, in the case of partial production, there is no requirement to add detail of an entire production process in the Site Master File. The site Master File should be as pictorial as possible when disclosing schematic layouts. The usage of narratives should be minimal in this context.
Even the slightest alternation in the QMS or production technique should be reflected in the site master plan.
CDSCO Medical Devices Manufacturing Registration adheres to different technicalities which might seek expert advice. These include the preparation of a site plan, the appointment of authorized personnel if the applicant belongs to a foreign territory, procurement of a GMP certificate, and so forth. Thus, it is advisable to get in touch with Professional Avenue like Corpbiz to help overcome such obstacles with ease.
Read our Article:Classification of Medical Devices by CDSCO: An Overview