As is the case with the Made in China 2025 initiative, the Make in India program has at least a decade of history to look back on, with some benefits accruing to the nation’s med-tech sector. All the same, Gunjan Bagla, CEO of Los Angeles-based Amritt Inc., told BioWorld that the initiative could be more successful if the legislature would tweak the laws to create a more helpful environment for industry.

China’s National Medical Products Administration is arguably more active than regulatory agencies in many nations in advancing guidance for AI in medical technology, but Chang-Hong Whitney, President/CEO of Whitney Consulting Ltd., told BioWorld that the premarket review process still carries some unpredictability.

Japan’s Pharmaceuticals and Medical Devices Agency has traditionally been less than receptive to clinical data from other nations, but that aversion is slowly giving way. Ames Gross of Pacific Bridge Medical told BioWorld that a trial conducted in another nation with significant representation of those of Japanese ancestry can go a long way toward obviating the need for a trial conducted in Japan.

As is the case with the Made in China 2025 initiative, the Make in India program has at least a decade of history to look back on, with some benefits accruing to the nation’s med-tech sector. All the same, Gunjan Bagla, CEO of Los Angeles-based Amritt Inc., told BioWorld that the initiative could be more successful if the legislature would tweak the laws to create a more helpful environment for industry.

China’s National Medical Products Administration is arguably more active than regulatory agencies in many nations in advancing guidance for AI in medical technology, but Chang-Hong Whitney, President/CEO of Whitney Consulting Ltd., told BioWorld that the premarket review process still carries some unpredictability.

The U.S. Federal Trade Commission has posted notice to health care companies that their use of noncompete agreements for physicians and nurses may violate the law. The advisory may allow physicians and nurses engaged in clinical trials to move to other employers, thus complicating the conduct of those trials.

Japan’s Pharmaceuticals and Medical Devices Agency has traditionally been less than receptive to clinical data from other nations, but that aversion is slowly giving way. Ames Gross of Pacific Bridge Medical told BioWorld that a trial conducted in another nation with significant representation of those of Japanese ancestry can go a long way toward obviating the need for a trial conducted in Japan.

The draft Medicare physician fee schedule (MPFS) for 2026 proposed to treat skin substitutes as incident-to supplies in the related procedures, but the blowback was pronounced and vigorous, with London-based Convatec plc arguing that the agency lacks the statutory authority to make such a change.

The first phase of the EU’s Data Act is now officially in place, although member state enforcement of the Act might be spotty. This is because several nations, including Germany, have yet to finalize implementing regulations for the Data Act, a problem these nations will have to fix as the secondary and tertiary compliance dates arrive in August 2026 and August 2027.

Health Canada posted a report on reduction of red tape, which includes a proposal for mutual recognition of other regulators’ inspections of device and drug manufacturing facilities.