Drugs Controller General invites comments on draft guidance document on “Essential Principles for safety and performance of Medical Devices”
In the backdrop of the upcoming enforcement of the Medical Devices Rules, 2017, which is 1st January, 2018, the Drugs Controller General, India (“DCGI”) has issued a draft guidance document on “Essential Principles for safety and performance of Medical Devices” (“Draft Guidance Note”).
This Draft Guidance Note has been prepared in consultation with the Medical Devices and IVD stakeholders.
Objections / suggestions are invited from all stakeholders, which needs to be sent within a period of three weeks either through e-mail to firstname.lastname@example.org or by post to the DDCI (MD), CDSCO HQ FDA Bhawan, Kotla Road, New Delhi – 110002.
The Draft Guidance Note is prepared to provide binding guidance for use in the manufacturing of medical devices which are intended to be sold in India. It also provides an overview on meeting the essential principles for safety and performance of medical devices. But does not dictate the manner in which the manufacture should prove that their medical device has met the essential principles laid down in this note.
Key Takeaways of the Draft Guidance Note are:
- Medical devices including in vitro diagnostic medical devices (“IVD”) should be designed and manufactured in such a way that their use does not compromise the clinical condition or the safety of patients or users of the devices.
- Manufacturer of a medical device, including in IVD, must apply the following safety principles based on the priority order, at the time of designing medical devices:
- identify known or foreseeable hazards and estimate the associated risks arising from the intended use and foreseeable misuse;
- eliminate risks as far as reasonably practicable through inherently safe design and manufacture;
3. reduce as far as reasonably practicable the remaining risks by taking adequate protection measures, including alarms; and
- inform users of any residual risks.
- The devices excluding IVD should be designed, manufactured and packaged in such a way, that it minimizes the risk posed by contaminants and residues to the persons transporting, storing and using the devices.
- While designing, and manufacturing medical devices other than IVD, particular attention has to be paid to some of the following requirements:
- the choice of materials used, particularly as regard toxicity, biodegradability and, where appropriate, flammability;
- the compatibility between the materials used and biological tissues, cells, and body fluids taking account of the intended purpose of the device;
3. the choice of materials used, reflecting, where appropriate, matters such as hardness, wear and fatigue strength.
- Where IVD medical devices include tissues, cells and substances originating from animals, the processing, preservation, testing and handling of tissues, cells and substances of animal origin should be carried out to provide optimal safety for user, professional or lay, or other person.
Please click on the hyperlink below to view the Draft Guidance Note in details.