Regulatory Guidelines for Import of Medical Devices as per Medical Devices Rules, 2017

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....per the requirements of the Medical Devices Rules, 2017 - reg. The attention of the Importers, Customs Brokers, and all concerned is invited to Medical Device Rules, 2017 published vide G.S.R. 78(E) dated 31.01.2017 and letter F. No. 29/Misc/03/2022-DC (273) dated 03.01.2023 issued by the Central Drugs Standard Control Organization, New Delhi on the above subject. 2. The Central Drugs Standa....

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....under licensing regime w.e.f. 01.10.2022 and 01.10.2023 respectively. Surgical Gloves and Medical Examination Gloves fall under the definition of Medical Devices and are classified under Class B and Class A respectively. 3. In this regard, it is brought to the notice of all stakeholders that all the Bills of Entry containing Medical Devices including Surgical and Medical Examination Gloves can ....

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...., such device shall conform to the standard laid down by the International Organization for Standardization (ISO) or the International Electro- Technical Commission (IEC), or by any other pharmacopeia standards. (3) In case of the standards which have not been specified under sub-rule (1) and sub-rule (2), the device shall conform to the validated manufacturer's standards. D.....